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Trial record 27 of 66 for:    strength | ( Map: India )

Nutrition, Physical Performance & Fitness in Indian School Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00876018
Recruitment Status : Completed
First Posted : April 6, 2009
Results First Posted : August 3, 2017
Last Update Posted : March 1, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Other
Conditions Physical Fitness
Nutritional Status
Interventions Other: Nutritional supplement
Other: Placebo
Enrollment 300
Recruitment Details Participants were recruited from three schools of Karnataka at a clinical site in Karnataka.
Pre-assignment Details A total of 379 participants were screened. Out of which 300 participants were randomized.
Arm/Group Title Experimental Group (Fortified Nutritional Supplement) Control Group A (Un-fortified Nutritional Powder) Control Group B (No Intervention)
Hide Arm/Group Description Participants were administered with fortified choco-malt beverage powder (including 19 key vitamins and minerals) as single serves of 40 gram (g) in 100 milliliter (mL) water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays. Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group) as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays. Participants were not administered with any intervention.
Period Title: Overall Study
Started 100 100 100
Completed 95 95 97
Not Completed 5 5 3
Reason Not Completed
Lost to Follow-up             0             1             1
Withdrew Consent due to Adverse Event             5             4             2
Arm/Group Title Experimental Group (Fortified Nutritional Supplement) Control Group A (Unfortified Nutritional Powder) Control Group B (No Intervention) Total
Hide Arm/Group Description Participants were administered with fortified choco-malt beverage powder as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays. Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group). Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays. Participants were not administered with any intervention. Total of all reporting groups
Overall Number of Baseline Participants 100 100 100 300
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 100 participants 100 participants 100 participants 300 participants
8.26  (1.02) 8.18  (1.01) 8.29  (1.04) 8.24  (1.02)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 100 participants 100 participants 300 participants
Female
50
  50.0%
50
  50.0%
50
  50.0%
150
  50.0%
Male
50
  50.0%
50
  50.0%
50
  50.0%
150
  50.0%
1.Primary Outcome
Title Change From Baseline in Maximal Aerobic Capacity (VO2max)- 12 Inch Step Test After 4 Months
Hide Description Maximal aerobic capacity (VO2max) is defined as the maximum rate of oxygen consumption, measured during incremental exercise. VO2max was measured with the help of an externally placed 12-inch step test to assess the aerobic fitness/cardio-respiratory endurance of the study participants. In this test, participants were asked to step at 22 steps a minute for 3 minutes. The pulse rate was recorded manually, within 15sec of stopping the test. VO2max was calculated as (VO2 x HRmax) divided by HR observed, where HRmax = 220-Age in years. HRmax= maximum heart rate. VO2 is equal to (0.2 x Stepping Rate) + (2.4 x Step height x Stepping Rate) + 3.5 mL/kg/min. mL/kg/min.= milliliter per kilogram per minute.
Time Frame Baseline, after 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis for this outcome was performed on all randomized population. Number of participants analyzed is the number of participants from the randomized population evaluated at specific time points for respective treatment arm.
Arm/Group Title Experimental Group (Fortified Nutritional Supplement) Control Group A (Unfortified Nutritional Powder) Control Group B (No Intervention)
Hide Arm/Group Description:
Participants were administered with fortified choco-malt beverage powder (including 19 key vitamins and minerals) as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group) as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
Participants were not administered with any intervention.
Overall Number of Participants Analyzed 100 100 100
Mean (Standard Deviation)
Unit of Measure: mL/kg/min.
At Baseline Number Analyzed 99 participants 100 participants 99 participants
36.8  (5.3) 37.9  (5.6) 37.0  (5.3)
After 4 months Number Analyzed 95 participants 95 participants 97 participants
38.9  (5.6) 37.6  (5.3) 37.8  (5.3)
Change from baseline after 4 months Number Analyzed 95 participants 95 participants 97 participants
2.00  (6.03) -0.25  (6.23) 0.7  (5.87)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Experimental Group (Fortified Nutritional Supplement), Control Group A (Unfortified Nutritional Powder)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method Mann Whitney U test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Experimental Group (Fortified Nutritional Supplement), Control Group B (No Intervention)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.147
Comments [Not Specified]
Method Mann Whitney U test
Comments [Not Specified]
2.Primary Outcome
Title Change From Baseline in Aerobic Capacity-shuttle Test (VO2peak) After 4 Months
Hide Description Aerobic capacity(VO2peak) is defined as maximum rate of oxygen consumption attained on a particular exercise test. VO2peak was measured by 20m shuttle run test to assess aerobic & whole body endurance. In this test, participants were asked to move around one cone to another placed at 19m distance, reversing direction & in accordance with a pace dictated by sound signal, that got progressively faster at one minute intervals. The initial pace was set at 4.0 km/hr & with subsequent increases of 0.5 km/hr every subsequent minute. This test was conducted in groups (of at least 3 children per group). The shuttle was stopped when either the participant chose to stop because of exhaustion or when participant was > 1m away from cone at 2 consecutive paced signals. The number of shuttles at stoppage was noted. VO2peak was calculated as 31.025 + (3.325 x speed) – (3.248 x age). Speed is speed attained in previous level of shuttle, computed as speed (km/hr) = v + 0.5 x n/60; and age is in years.
Time Frame Baseline, after 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis for this outcome was performed on all randomized population. Number of participants analyzed is the number of participants from the randomized population evaluated at specific time points for respective treatment arm.
Arm/Group Title Experimental Group (Fortified Nutritional Supplement) Control Group A (Unfortified Nutritional Powder) Control Group B (No Intervention)
Hide Arm/Group Description:
Participants were administered with fortified choco-malt beverage powder (including 19 key vitamins and minerals) as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group) as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
Participants were not administered with any intervention.
Overall Number of Participants Analyzed 100 100 100
Mean (Standard Deviation)
Unit of Measure: km/hr*years
At Baseline Number Analyzed 100 participants 100 participants 100 participants
31.6  (4.3) 32.8  (4.1) 32.4  (4.2)
After 4 months Number Analyzed 95 participants 95 participants 97 participants
39.1  (4.3) 38.6  (3.7) 38.2  (4.1)
Change from baseline after 4 months Number Analyzed 95 participants 95 participants 97 participants
7.52  (3.51) 5.74  (6.02) 5.80  (3.56)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Experimental Group (Fortified Nutritional Supplement), Control Group A (Unfortified Nutritional Powder)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Mann Whitney U test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Experimental Group (Fortified Nutritional Supplement), Control Group B (No Intervention)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method Mann Whitney U test
Comments [Not Specified]
3.Primary Outcome
Title Change From Baseline in Time Taken for 40 Meter (m) Sprint After 4 Months
Hide Description A 40m sprint was used to assess speed with time taken to complete the sprint being recorded manually using a digital stopwatch. The moment any part of the designated participant’s body reached the marker level, the corresponding examiner stopped their watches and recorded the time for the sprint.
Time Frame Baseline, after 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis for this outcome was performed on all randomized population. Number of participants analyzed is the number of participants from the randomized population evaluated at specific time points for respective treatment arm.
Arm/Group Title Experimental Group (Fortified Nutritional Supplement) Control Group A (Unfortified Nutritional Powder) Control Group B (No Intervention)
Hide Arm/Group Description:
Participants were administered with fortified choco-malt beverage powder as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group). Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
Participants were not administered with any intervention.
Overall Number of Participants Analyzed 100 100 100
Mean (Standard Deviation)
Unit of Measure: seconds (Sec)
At Baseline Number Analyzed 100 participants 100 participants 100 participants
9.0  (1.3) 8.9  (1.0) 8.9  (1.0)
After 4 months Number Analyzed 95 participants 95 participants 97 participants
8.6  (1.1) 8.9  (1.0) 8.639  (1.0)
Change from baseline after 4 months Number Analyzed 95 participants 95 participants 97 participants
-0.34  (0.99) -0.05  (0.93) -0.26  (1.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Experimental Group (Fortified Nutritional Supplement), Control Group A (Unfortified Nutritional Powder)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.153
Comments [Not Specified]
Method Mann Whitney U test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Experimental Group (Fortified Nutritional Supplement), Control Group B (No Intervention)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.903
Comments [Not Specified]
Method Mann Whitney U test
Comments [Not Specified]
4.Primary Outcome
Title Change From Baseline in Visual Reaction Time After 4 Months
Hide Description Visual reaction time was assessed using a customized computer based programme. Participant was provided with a periodic random test visual stimulus among many other ‘non test’ stimuli. Participant was required to tap the space bar of the computer as fast as possible on the appearance of the test visual stimulus. Three test visual cues were provided at each sitting to allow for training effects. The shortest visual reaction time of the three visual cues was used in analyses.
Time Frame Baseline, after 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis for this outcome was performed on all randomized population. Number of participants analyzed is the number of participants from the randomized population evaluated at specific time points for respective treatment arm.
Arm/Group Title Experimental Group (Fortified Nutritional Supplement) Control Group A (Unfortified Nutritional Powder) Control Group B (No Intervention)
Hide Arm/Group Description:
Participants were administered with fortified choco-malt beverage powder as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group). Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
Participants were not administered with any intervention.
Overall Number of Participants Analyzed 100 100 100
Mean (Standard Deviation)
Unit of Measure: milliseconds (msec)
At Baseline Number Analyzed 100 participants 100 participants 100 participants
958  (217) 932  (189) 939  (210)
After 4 months Number Analyzed 95 participants 95 participants 97 participants
863  (144) 884  (122) 864  (157)
Change from baseline after 4 months Number Analyzed 95 participants 95 participants 97 participants
-94  (227) -46  (180) -72  (249)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Experimental Group (Fortified Nutritional Supplement), Control Group A (Unfortified Nutritional Powder)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.143
Comments [Not Specified]
Method Mann Whitney U test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Experimental Group (Fortified Nutritional Supplement), Control Group B (No Intervention)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.678
Comments [Not Specified]
Method Mann Whitney U test
Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in Maximal Handgrip Strength for Dominant and Non-dominant Hand After 4 Months
Hide Description Maximal handgrip strength was measured using a Jamar handgrip dynamometer in dominant and non-dominant arms. The width of the grip was noted during the pre-intervention assessment and kept constant for an individual during the subsequent post-intervention assessment. Muscle strength was recorded as the best (highest) value for the dominant and non-dominant sides as well as average value of the 3 measurements.
Time Frame Baseline, after 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis for this outcome was performed on all randomized population. Number of participants analyzed is the number of participants from the randomized population evaluated at specific time points for respective treatment arm.
Arm/Group Title Experimental Group (Fortified Nutritional Supplement) Control Group A (Unfortified Nutritional Powder) Control Group B (No Intervention)
Hide Arm/Group Description:
Participants were administered with fortified choco-malt beverage powder as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group). Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
Participants were not administered with any intervention.
Overall Number of Participants Analyzed 100 100 100
Mean (Standard Deviation)
Unit of Measure: kg
Dominant hand, At Baseline Number Analyzed 100 participants 100 participants 100 participants
9.7  (3.9) 9.4  (3.7) 9.8  (3.4)
Dominant hand, after 4 months Number Analyzed 95 participants 95 participants 97 participants
11.1  (3.4) 10.6  (3.0) 10.9  (3.2)
Dominant hand, change after 4 months Number Analyzed 95 participants 95 participants 97 participants
1.41  (2.52) 1.21  (2.91) 1.09  (3.15)
Non-dominant hand, at Baseline Number Analyzed 100 participants 100 participants 100 participants
8.6  (3.5) 8.6  (3.5) 8.5  (3.2)
Non-dominant hand, after 4 months Number Analyzed 95 participants 95 participants 96 participants
9.9  (3.4) 9.47  (3.0) 9.6  (2.6)
Non-dominant hand,change after 4 months Number Analyzed 95 participants 95 participants 96 participants
1.34  (2.55) 0.72  (2.85) 1.11  (2.44)
6.Secondary Outcome
Title Change From Baseline in Time to Fatigue After 4 Months
Hide Description Time to fatigue is defined as the time in seconds taken for the handgrip to fall from maximal value to 50% of the maximal value. Time to fatigue was measured using Jamar hand dynamometer to assess the muscle strength. In this test, participants were required to sustain a maximal contraction until the force dropped to 50% of its maximal value.
Time Frame Baseline, after 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis for this outcome was performed on all randomized population. Number of participants analyzed is the number of participants from the randomized population evaluated at specific time points for respective treatment arm.
Arm/Group Title Experimental Group (Fortified Nutritional Supplement) Control Group A (Unfortified Nutritional Powder) Control Group B (No Intervention)
Hide Arm/Group Description:
Participants were administered with fortified choco-malt beverage powder as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group). Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
Participants were not administered with any intervention.
Overall Number of Participants Analyzed 100 100 100
Mean (Standard Deviation)
Unit of Measure: sec
At Baseline Number Analyzed 100 participants 100 participants 100 participants
12.31  (6.71) 12.36  (7.66) 11.13  (9.85)
After 4 months Number Analyzed 95 participants 95 participants 96 participants
14.71  (7.2457) 14.62  (6.35) 14.03  (7.25)
Change from baseline after 4 months Number Analyzed 95 participants 95 participants 96 participants
2.64  (6.37) 2.03  (8.39) 2.78  (6.26)
7.Secondary Outcome
Title Change From Baseline in Rate of Decline of Muscle Strength After 4 Months
Hide Description Rate of decline of muscle strength was assessed to measure the muscle endurance of forearm. Sustained isometric contraction of forearm flexors to 50% of maximal handgrip was measured using the Jamar hand dynamometer and was performed on the non-dominant arm. The participant was required to sustain a maximal contraction until the force dropped to 50% of its maximal value. Rate of decline of muscle strength was calculated as 50 percent of maximal value of contraction divided by time to fatigue (50%maximal value of contraction (MVC)/Time to fatigue).
Time Frame Baseline, after 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis for this outcome was performed on all randomized population. Number of participants analyzed is the number of participants from the randomized population evaluated at specific time points for respective treatment arm.
Arm/Group Title Experimental Group (Fortified Nutritional Supplement) Control Group A (Unfortified Nutritional Powder) Control Group B (No Intervention)
Hide Arm/Group Description:
Participants were administered with fortified choco-malt beverage powder as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group). Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
Participants were not administered with any intervention.
Overall Number of Participants Analyzed 100 100 100
Mean (Standard Deviation)
Unit of Measure: kg/sec
At Baseline Number Analyzed 100 participants 100 participants 100 participants
0.38  (0.23) 0.38  (0.24) 0.42  (0.26)
After 4 months Number Analyzed 95 participants 95 participants 97 participants
0.36  (0.17) 0.33  (0.16) 0.35  (0.16)
Change from baseline after 4 months Number Analyzed 95 participants 95 participants 96 participants
-0.01  (0.25) -0.05  (0.27) -0.06  (0.28)
8.Secondary Outcome
Title Change From Baseline in Hemoglobin Level After 4 Months
Hide Description Hemoglobin level was measured to assess the iron status in study participants.
Time Frame Baseline, after 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis for this outcome was performed on all randomized population. Number of participants analyzed is the number of participants from the randomized population evaluated at specific time points for respective treatment arm.
Arm/Group Title Experimental Group (Fortified Nutritional Supplement) Control Group A (Unfortified Nutritional Powder) Control Group B (No Intervention)
Hide Arm/Group Description:
Participants were administered with fortified choco-malt beverage powder as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group). Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
Participants were not administered with any intervention.
Overall Number of Participants Analyzed 100 100 100
Median (Inter-Quartile Range)
Unit of Measure: gram per decilitre (g/dl)
At Baseline
12.9
(12.3 to 13.4)
12.94
(12.50 to 13.60)
12.88
(12.30 to 13.48)
After 4 months
12.7
(12.0 to 13.1)
12.60
(11.80 to 13.30)
12.60
(12.05 to 13.15)
Change from baseline after 4 months
-0.20
(-0.70 to 0.20)
-0.31
(-0.80 to 0.10)
-0.20
(-0.70 to 0.10)
9.Secondary Outcome
Title Change From Baseline in Ferritin Level After 4 Months
Hide Description Ferritin level was measured to assess the iron status of study participants.
Time Frame Baseline, after 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis for this outcome was performed on all randomized population. Number of participants analyzed is the number of participants from the randomized population evaluated at specific time points for respective treatment arm.
Arm/Group Title Experimental Group (Fortified Nutritional Supplement) Control Group A (Unfortified Nutritional Powder) Control Group B (No Intervention)
Hide Arm/Group Description:
Participants were administered with fortified choco-malt beverage powder as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group). Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
Participants were not administered with any intervention.
Overall Number of Participants Analyzed 100 100 100
Median (Inter-Quartile Range)
Unit of Measure: nanogram per mililitre (ng/mL)
At Baseline Number Analyzed 100 participants 100 participants 100 participants
27.59
(17.32 to 45.46)
20.17
(13.14 to 28.96)
24.48
(16.88 to 39.76)
After 4 months Number Analyzed 93 participants 94 participants 95 participants
38.78
(29.06 to 54.95)
23.89
(14.58 to 34.34)
25.79
(16.92 to 36.92)
Change from baseline after 4 months Number Analyzed 92 participants 91 participants 92 participants
9.36
(2.42 to 17.61)
1.94
(-1.18 to 8.89)
0.17
(-5.44 to 6.64)
10.Secondary Outcome
Title Change From Baseline in Soluble Transferring Receptors (sTr) After 4 Months
Hide Description Soluble transferring receptors (sTr) was measured to assess the iron status of study participants.
Time Frame Baseline, after 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis for this outcome was performed on all randomized population. Number of participants analyzed is the number of participants from the randomized population evaluated at specific time points for respective treatment arm.
Arm/Group Title Experimental Group (Fortified Nutritional Supplement) Control Group A (Unfortified Nutritional Powder) Control Group B (No Intervention)
Hide Arm/Group Description:
Participants were administered with fortified choco-malt beverage powder as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group). Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
Participants were not administered with any intervention.
Overall Number of Participants Analyzed 100 100 100
Median (Inter-Quartile Range)
Unit of Measure: miligram per litre (mg/L)
At Baseline Number Analyzed 100 participants 100 participants 100 participants
5.91
(5.27 to 7.16)
6.20
(5.56 to 7.34)
5.98
(5.29 to 6.94)
After 4 months Number Analyzed 95 participants 95 participants 97 participants
5.75
(5.11 to 6.65)
5.99
(5.18 to 7.48)
6.01
(5.35 to 6.56)
Change from baseline after 4 months Number Analyzed 95 participants 95 participants 97 participants
-0.33
(-0.95 to 0.20)
-0.24
(-0.69 to 0.24)
-0.02
(-0.40 to 0.43)
11.Secondary Outcome
Title Change From Baseline in C-reactive Protein Level After 4 Months
Hide Description C-reactive protein level was measured.
Time Frame Baseline, after 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis for this outcome was performed on all randomized population. Number of participants analyzed is the number of participants from the randomized population evaluated at specific time points for respective treatment arm.
Arm/Group Title Experimental Group (Fortified Nutritional Supplement) Control Group A (Unfortified Nutritional Powder) Control Group B (No Intervention)
Hide Arm/Group Description:
Participants were administered with fortified choco-malt beverage powder as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group). Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
Participants were not administered with any intervention.
Overall Number of Participants Analyzed 100 100 100
Median (Inter-Quartile Range)
Unit of Measure: mg/L
At Baseline Number Analyzed 100 participants 100 participants 100 participants
0.20
(0 to 0.70)
0.30
(0 to 0.78)
0.40
(0 to 0.80)
After 4 months Number Analyzed 95 participants 95 participants 97 participants
0.40
(0 to 0.80)
0.20
(0 to 0.80)
0.40
(0.10 to 0.70)
Change from baseline after 4 months Number Analyzed 95 participants 95 participants 97 participants
0
(-0.20 to 0.40)
0
(-0.50 to 0.30)
0
(-0.40 to 0.30)
12.Secondary Outcome
Title Change From Baseline in Vitamin B2 Level After 4 Months
Hide Description Vitamin B2 level was measured by erythrocyte glutathione reductase coefficient (EGRAC) method as micronutrient markers in study participants.
Time Frame Baseline, after 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis for this outcome was performed on all randomized population. Number of participants analyzed is the number of participants from the randomized population evaluated at specific time points for respective treatment arm.
Arm/Group Title Experimental Group (Fortified Nutritional Supplement) Control Group A (Unfortified Nutritional Powder) Control Group B (No Intervention)
Hide Arm/Group Description:
Participants were administered with fortified choco-malt beverage powder as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group). Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
Participants were not administered with any intervention.
Overall Number of Participants Analyzed 100 100 100
Median (Inter-Quartile Range)
Unit of Measure: ratio
At Baseline Number Analyzed 100 participants 100 participants 100 participants
1.56
(1.47 to 1.64)
1.52
(1.43 to 1.61)
1.57
(1.48 to 1.70)
After 4 months Number Analyzed 95 participants 95 participants 97 participants
1.22
(1.17 to 1.28)
1.47
(1.41 to 1.56)
1.56
(1.47 to 1.69)
Change from baseline after 4 months Number Analyzed 95 participants 95 participants 97 participants
-0.32
(-0.41 to -0.26)
-0.04
(-0.10 to 0.00)
0.00
(-0.08 to 0.07)
13.Secondary Outcome
Title Change From Baseline in Vitamin B6 Level After 4 Months
Hide Description Vitamin B6 level was measured as micronutrient markers in study participants.
Time Frame Baseline, after 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis for this outcome was performed on all randomized population. Number of participants analyzed is the number of participants from the randomized population evaluated at specific time points for respective treatment arm.
Arm/Group Title Experimental Group (Fortified Nutritional Supplement) Control Group A (Unfortified Nutritional Powder) Control Group B (No Intervention)
Hide Arm/Group Description:
Participants were administered with fortified choco-malt beverage powder as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group). Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
Participants were not administered with any intervention.
Overall Number of Participants Analyzed 100 100 100
Median (Inter-Quartile Range)
Unit of Measure: nano mole per litre (nmol/L)
At Baseline Number Analyzed 97 participants 96 participants 98 participants
33.77
(20.71 to 50.30)
34.28
(22.44 to 50.66)
39.27
(21.76 to 51.98)
After 4 months Number Analyzed 94 participants 94 participants 96 participants
59.66
(39.62 to 79.15)
37.79
(27.02 to 50.14)
39.77
(24.29 to 61.77)
Change from baseline after 4 months Number Analyzed 91 participants 90 participants 95 participants
23.96
(6.74 to 45.00)
4.72
(-5.36 to 16.14)
2.52
(-11.02 to 19.60)
14.Secondary Outcome
Title Change From Baseline in Vitamin B12 Level After 4 Months
Hide Description Vitamin B12 was measured by electrochemilumenesence method as micronutrient markers in study participants.
Time Frame Baseline, after 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis for this outcome was performed on all randomized population. Number of participants analyzed is the number of participants from the randomized population evaluated at specific time points for respective treatment arm.
Arm/Group Title Experimental Group (Fortified Nutritional Supplement) Control Group A (Unfortified Nutritional Powder) Control Group B (No Intervention)
Hide Arm/Group Description:
Participants were administered with fortified choco-malt beverage powder as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group). Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
Participants were not administered with any intervention.
Overall Number of Participants Analyzed 100 100 100
Median (Inter-Quartile Range)
Unit of Measure: picomole per litre(pmol/L)
At Baseline Number Analyzed 100 participants 100 participants 100 participants
210.03
(166.77 to 285.74)
213.02
(163.21 to 296.66)
224.02
(164.41 to 270.24)
After 4 months Number Analyzed 95 participants 95 participants 97 participants
427.82
(348.71 to 565.46)
218.30
(171.22 to 315.05)
220.44
(158.56 to 272.99)
Change from baseline after 4 months Number Analyzed 95 participants 95 participants 97 participants
210.77
(164.64 to 266.12)
5.31
(-25.90 to 28.86)
-10.11
(-39.37 to 15.35)
15.Secondary Outcome
Title Change From Baseline in Folate Level After 4 Months
Hide Description Folate level was measured as micronutrient markers in study participants.
Time Frame Baseline, after 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis for this outcome was performed on all randomized population. Number of participants analyzed is the number of participants from the randomized population evaluated at specific time points for respective treatment arm.
Arm/Group Title Experimental Group (Fortified Nutritional Supplement) Control Group A (Unfortified Nutritional Powder) Control Group B (No Intervention)
Hide Arm/Group Description:
Participants were administered with fortified choco-malt beverage powder as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group). Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
Participants were not administered with any intervention.
Overall Number of Participants Analyzed 100 100 100
Median (Inter-Quartile Range)
Unit of Measure: nanogram per mililitre (ng/mL)
At Baseline Number Analyzed 100 participants 100 participants 100 participants
583.68
(532.68 to 669.43)
585.29
(543.79 to 644.00)
592.82
(510.63 to 684.32)
After 4 months Number Analyzed 95 participants 95 participants 97 participants
1013.40
(878.96 to 1147.08)
592.41
(533.26 to 647.71)
592.93
(510.63 to 688.04)
Change from baseline after 4 months Number Analyzed 95 participants 95 participants 97 participants
396.97
(286.74 to 496.87)
-13.03
(-49.56 to 40.02)
-9.62
(-56.45 to 48.42)
16.Secondary Outcome
Title Change From Baseline in Vitamin C Level After 4 Months
Hide Description Vitamin C level was measured as micronutrient markers in study participants.
Time Frame Baseline, after 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis for this outcome was performed on all randomized population. Number of participants analyzed is the number of participants from the randomized population evaluated at specific time points for respective treatment arm.
Arm/Group Title Experimental Group (Fortified Nutritional Supplement) Control Group A (Unfortified Nutritional Powder) Control Group B (No Intervention)
Hide Arm/Group Description:
Participants were administered with fortified choco-malt beverage powder as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group). Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays.
Participants were not administered with any intervention.
Overall Number of Participants Analyzed 100 100 100
Median (Inter-Quartile Range)
Unit of Measure: miligram per decilitre (mg/dL)
At Baseline Number Analyzed 96 participants 100 participants 96 participants
0.69
(0.43 to 1.04)
0.61
(0.41 to 0.98)
0.72
(0.45 to 1.23)
After 4 months Number Analyzed 95 participants 93 participants 96 participants
1.49
(1.20 to 1.75)
0.77
(0.46 to 1.19)
0.76
(0.43 to 1.21)
Change from baseline after 4 months Number Analyzed 92 participants 93 participants 93 participants
0.83
(0.48 to 1.09)
0.13
(-0.33 to 0.45)
0.09
(-0.46 to 0.44)
Time Frame [Not Specified]
Adverse Event Reporting Description General Disorders adverse events (AEs) terms are not coded.
 
Arm/Group Title Experimental Group (Fortified Nutritional Supplement) Control Group A (Unfortified Nutritional Powder) Control Group B (No Intervention)
Hide Arm/Group Description Participants were administered with fortified choco-malt beverage powder as single serves of 40g in 100mL water. Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays. Participants were administered with unfortified choco-malt beverage powder (energy equivalent of fortified choco-malt powder in experimental group). Administration was done once a day for 4 months under study personnel supervision on all school working days (6 days per week) and for self-consumption on weekends and/ or holidays. Participants were not administered with any intervention.
All-Cause Mortality
Experimental Group (Fortified Nutritional Supplement) Control Group A (Unfortified Nutritional Powder) Control Group B (No Intervention)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/100 (0.00%)   0/100 (0.00%)   0/100 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Experimental Group (Fortified Nutritional Supplement) Control Group A (Unfortified Nutritional Powder) Control Group B (No Intervention)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/100 (0.00%)   0/100 (0.00%)   0/100 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Experimental Group (Fortified Nutritional Supplement) Control Group A (Unfortified Nutritional Powder) Control Group B (No Intervention)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   29/100 (29.00%)   25/100 (25.00%)   8/100 (8.00%) 
Gastrointestinal disorders       
Insect bite  1/100 (1.00%)  0/100 (0.00%)  0/100 (0.00%) 
General disorders       
Vomiting  5/100 (5.00%)  2/100 (2.00%)  0/100 (0.00%) 
Loose stools  1/100 (1.00%)  0/100 (0.00%)  0/100 (0.00%) 
Skin allergy  1/100 (1.00%)  2/100 (2.00%)  0/100 (0.00%) 
Abdominal pain  1/100 (1.00%)  0/100 (0.00%)  1/100 (1.00%) 
Excessive tiredness after 20m shuttle  1/100 (1.00%)  1/100 (1.00%)  1/100 (1.00%) 
Abrasion during 20 m shuttle  0/100 (0.00%)  1/100 (1.00%)  1/100 (1.00%) 
Felt dizzy after blood collection  2/100 (2.00%)  1/100 (1.00%)  0/100 (0.00%) 
Fever  14/100 (14.00%)  8/100 (8.00%)  3/100 (3.00%) 
Otitis media  1/100 (1.00%)  0/100 (0.00%)  0/100 (0.00%) 
Urinary tract infection  0/100 (0.00%)  1/100 (1.00%)  0/100 (0.00%) 
Abrasion  0/100 (0.00%)  1/100 (1.00%)  0/100 (0.00%) 
Fall/Fracture  1/100 (1.00%)  1/100 (1.00%)  1/100 (1.00%) 
Chicken pox  0/100 (0.00%)  1/100 (1.00%)  0/100 (0.00%) 
Leg wound  1/100 (1.00%)  1/100 (1.00%)  0/100 (0.00%) 
Scabies  0/100 (0.00%)  0/100 (0.00%)  1/100 (1.00%) 
Tooth ache  0/100 (0.00%)  2/100 (2.00%)  0/100 (0.00%) 
Respiratory tract infection  0/100 (0.00%)  1/100 (1.00%)  0/100 (0.00%) 
Ear/leg pain  0/100 (0.00%)  1/100 (1.00%)  0/100 (0.00%) 
Perianal abscess  0/100 (0.00%)  1/100 (1.00%)  0/100 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00876018     History of Changes
Other Study ID Numbers: IND 001/2008
First Submitted: April 3, 2009
First Posted: April 6, 2009
Results First Submitted: April 25, 2017
Results First Posted: August 3, 2017
Last Update Posted: March 1, 2018