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Probing the Synergistic Effect of Pre-Biotics & Iron Fortificants in Anemic Subjects

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ClinicalTrials.gov Identifier: NCT03894449
Recruitment Status : Completed
First Posted : March 28, 2019
Results First Posted : August 22, 2019
Last Update Posted : August 22, 2019
Sponsor:
Information provided by (Responsible Party):
ABDUL MOMIN RIZWAN AHMAD, University of Veterinary and Animal Sciences, Lahore - Pakistan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Iron-deficiency
Intervention Combination Product: Prebiotic + Iron Forificant
Enrollment 75
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Only Prebiotic Inulin & Iron Salt NaFeEDTA Prebiotic Inulin & Iron Salt NaFeEDTA (2) Prebiotic Inulin & Iron Salt FeS04 Prebiotic GOS & Iron Salt NaFeEDTA
Hide Arm/Group Description Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects. Prebiotic + Iron Forificant: A combination dosage of 963 mg/kg Inulin and 10 ppm NaFeEDTA was given to the study subjects. Prebiotic + Iron Forificant: A combination dosage of 963 mg/kg Inulin and 20 ppm NaFeEDTA was given to the study subjects. Prebiotic + Iron Forificant: A combination dosage of 963 mg/kg Inulin and 30 ppm FeSO4 was given to the study subjects. Prebiotic + Iron Forificant: A combination dosage of 963 mg/kg GOS and 20 ppm NaFeEDTA was given to the study subjects.
Period Title: Overall Study
Started 15 15 15 15 15
Completed 15 15 15 15 15
Not Completed 0 0 0 0 0
Arm/Group Title Placebo Only Prebiotic Inulin & Iron Salt NaFeEDTA Prebiotic Inulin & Iron Salt NaFeEDTA (2) Prebiotic Inulin & Iron Salt FeS04 Prebiotic GOS & Iron Salt NaFeEDTA Total
Hide Arm/Group Description Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects. Prebiotic + Iron Forificant: A combination dosage of 963 mg/kg Inulin and 10 ppm NaFeEDTA was given to the study subjects. Prebiotic + Iron Forificant: A combination dosage of 963 mg/kg Inulin and 20 ppm NaFeEDTA was given to the study subjects. Prebiotic + Iron Forificant: A combination dosage of 963 mg/kg Inulin and 30 ppm FeSO4 was given to the study subjects. Prebiotic + Iron Forificant: A combination dosage of 963 mg/kg GOS and 20 ppm NaFeEDTA was given to the study subjects. Total of all reporting groups
Overall Number of Baseline Participants 15 15 15 15 15 75
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 15 participants 15 participants 15 participants 75 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
15
 100.0%
15
 100.0%
15
 100.0%
15
 100.0%
15
 100.0%
75
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 15 participants 15 participants 15 participants 75 participants
Female
15
 100.0%
15
 100.0%
15
 100.0%
15
 100.0%
15
 100.0%
75
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Pakistan Number Analyzed 15 participants 15 participants 15 participants 15 participants 15 participants 75 participants
15 15 15 15 15 75
1.Primary Outcome
Title Change in Hemoglobin Concentration From Baseline to 90 Days
Hide Description [Not Specified]
Time Frame Baseline, 30 days, 60 days, 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Only Prebiotic Inulin & Iron Salt FeSO4 Prebiotic GOS & Iron Salt FeSO4 Prebiotic Inulin & Iron Salt NaFeEDTA Prebiotic GOS & Iron Salt NaFeEDTA
Hide Arm/Group Description:
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Overall Number of Participants Analyzed 15 15 15 15 15
Mean (Standard Deviation)
Unit of Measure: g/dL
Baseline 11.44  (0.04) 11.58  (0.02) 11.54  (0.01) 11.61  (0.02) 11.28  (0.04)
30 days 11.52  (0.01) 11.71  (0.01) 11.62  (0.01) 11.78  (0.03) 11.54  (0.02)
60 days 11.64  (0.01) 11.83  (0.01) 11.74  (0.01) 11.90  (0.01) 11.84  (0.02)
90 days 11.91  (0.02) 12.04  (0.03) 11.85  (0.01) 12.17  (0.04) 12.33  (0.02)
2.Primary Outcome
Title Change in Hematocrit in Concentration From Baseline to 90 Days
Hide Description [Not Specified]
Time Frame Baseline, 30 days, 60 days, 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Only Prebiotic Inulin & Iron Salt FeSO4 Prebiotic GOS & Iron Salt FeSO4 Prebiotic Inulin & Iron Salt NaFeEDTA Prebiotic GOS & Iron Salt NaFeEDTA
Hide Arm/Group Description:
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Overall Number of Participants Analyzed 15 15 15 15 15
Mean (Standard Deviation)
Unit of Measure: % of RBCs in blood
Baseline 30.26  (0.17) 33.76  (0.19) 32.77  (0.07) 33.50  (0.06) 31.50  (0.06)
30 days 31.62  (0.04) 34.84  (0.12) 33.72  (0.08) 34.59  (0.09) 33.81  (0.13)
60 days 32.65  (0.03) 35.14  (0.10) 34.76  (0.17) 35.60  (0.07) 35.24  (0.06)
90 days 34.36  (0.16) 36.43  (0.07) 36.17  (0.07) 36.56  (0.06) 37.86  (0.26)
3.Primary Outcome
Title Change in Mean Corpuscular Volume From Baseline to 90 Days
Hide Description [Not Specified]
Time Frame Baseline, 30 days, 60 days, 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Only Prebiotic Inulin & Iron Salt FeSO4 Prebiotic GOS & Iron Salt FeSO4 Prebiotic Inulin & Iron Salt NaFeEDTA Prebiotic GOS & Iron Salt NaFeEDTA
Hide Arm/Group Description:
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Overall Number of Participants Analyzed 15 15 15 15 15
Mean (Standard Deviation)
Unit of Measure: fL
Baseline 68.53  (0.11) 69.56  (0.11) 73.79  (0.19) 76.61  (0.13) 78.06  (0.09)
30 days 70.46  (0.29) 71.63  (0.24) 74.70  (0.17) 78.77  (0.14) 80.03  (0.13)
60 days 72.72  (0.09) 75.11  (0.49) 80.18  (0.17) 81.82  (0.17) 81.96  (0.14)
90 days 77.09  (0.15) 78.64  (0.17) 83.77  (0.13) 83.64  (0.15) 85.59  (0.24)
4.Primary Outcome
Title Change in Mean Corpuscular Hemoglobin From Baseline to 90 Days
Hide Description [Not Specified]
Time Frame Baseline, 30 days, 60 days, 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Only Prebiotic Inulin & Iron Salt FeSO4 Prebiotic GOS & Iron Salt FeSO4 Prebiotic Inulin & Iron Salt NaFeEDTA Prebiotic GOS & Iron Salt NaFeEDTA
Hide Arm/Group Description:
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Overall Number of Participants Analyzed 15 15 15 15 15
Mean (Standard Deviation)
Unit of Measure: pg
Baseline 21.94  (1.35) 23.63  (1.02) 20.63  (0.79) 24.02  (0.69) 24.56  (0.79)
30 days 23.24  (1.14) 24.83  (0.86) 21.86  (0.74) 25.31  (1.08) 27.42  (0.66)
60 days 24.47  (1.00) 25.05  (0.45) 24.29  (0.69) 26.47  (0.28) 28.26  (0.88)
90 days 25.09  (0.89) 26.76  (0.59) 26.28  (0.51) 26.93  (0.26) 30.75  (0.81)
5.Primary Outcome
Title Change in Mean Corpuscular Hemoglobin Concentration From Baseline to 90 Days
Hide Description [Not Specified]
Time Frame Baseline, 30 days, 60 days, 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Only Prebiotic Inulin & Iron Salt FeSO4 Prebiotic GOS & Iron Salt FeSO4 Prebiotic Inulin & Iron Salt NaFeEDTA Prebiotic GOS & Iron Salt NaFeEDTA
Hide Arm/Group Description:
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Overall Number of Participants Analyzed 15 15 15 15 15
Mean (Standard Deviation)
Unit of Measure: g/dL
Baseline 31.44  (0.77) 29.30  (0.79) 28.06  (0.31) 29.05  (0.50) 28.51  (0.38)
30 days 31.07  (0.74) 30.30  (1.11) 30.08  (0.76) 30.74  (0.67) 30.67  (0.77)
60 days 31.70  (0.45) 31.91  (0.59) 31.19  (0.94) 33.42  (0.96) 34.25  (0.85)
90 days 32.78  (0.58) 33.46  (0.83) 33.13  (0.94) 34.15  (1.06) 36.91  (0.98)
6.Primary Outcome
Title Change in Serum Iron Levels From Baseline to 90 Days
Hide Description [Not Specified]
Time Frame Baseline, 30 days, 60 days, 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Only Prebiotic Inulin & Iron Salt FeSO4 Prebiotic GOS & Iron Salt FeSO4 Prebiotic Inulin & Iron Salt NaFeEDTA Prebiotic GOS & Iron Salt NaFeEDTA
Hide Arm/Group Description:
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Overall Number of Participants Analyzed 15 15 15 15 15
Mean (Standard Deviation)
Unit of Measure: mcg/dL
Baseline 68.41  (0.70) 70.97  (0.70) 72.65  (0.50) 71.41  (0.60) 72.60  (0.33)
30 days 69.17  (0.85) 72.34  (1.01) 73.95  (0.77) 72.62  (0.73) 74.51  (0.39)
60 days 70.25  (0.85) 74.34  (1.12) 75.50  (0.90) 73.96  (0.99) 76.61  (0.53)
90 days 70.93  (0.95) 75.36  (1.23) 77.42  (0.91) 76.16  (1.09) 79.10  (0.95)
7.Primary Outcome
Title Change in Serum Folate Levels From Baseline to 90 Days
Hide Description [Not Specified]
Time Frame Baseline, 30 days, 60 days, 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Only Prebiotic Inulin & Iron Salt FeSO4 Prebiotic GOS & Iron Salt FeSO4 Prebiotic Inulin & Iron Salt NaFeEDTA Prebiotic GOS & Iron Salt NaFeEDTA
Hide Arm/Group Description:
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Overall Number of Participants Analyzed 15 15 15 15 15
Mean (Standard Deviation)
Unit of Measure: ng/mL
Baseline 8.74  (0.12) 9.26  (0.18) 8.05  (0.08) 8.96  (0.11) 8.20  (0.05)
30 days 8.81  (0.11) 10.03  (0.17) 8.32  (0.10) 9.40  (0.12) 9.97  (0.07)
60 days 8.88  (0.09) 10.31  (0.15) 8.99  (0.11) 9.75  (0.13) 10.87  (0.12)
90 days 8.94  (0.09) 10.74  (0.16) 9.46  (0.13) 10.02  (0.14) 11.01  (0.17)
8.Primary Outcome
Title Change in Serum Ferritin Levels From Baseline to 90 Days
Hide Description [Not Specified]
Time Frame Baseline, 30 days, 60 days, 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Only Prebiotic Inulin & Iron Salt FeSO4 Prebiotic GOS & Iron Salt FeSO4 Prebiotic Inulin & Iron Salt NaFeEDTA Prebiotic GOS & Iron Salt NaFeEDTA
Hide Arm/Group Description:
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Overall Number of Participants Analyzed 15 15 15 15 15
Mean (Standard Deviation)
Unit of Measure: ng/mL
Baseline 11.76  (0.11) 13.73  (0.18) 13.29  (0.31) 12.03  (0.09) 12.67  (0.23)
30 days 11.86  (0.08) 14.09  (0.53) 13.59  (0.34) 12.86  (0.10) 13.56  (0.24)
60 days 11.98  (0.09) 16.28  (0.54) 14.31  (0.37) 13.37  (0.14) 14.77  (0.25)
90 days 12.04  (0.17) 16.88  (0.55) 15.77  (0.36) 15.10  (0.27) 17.55  (0.21)
9.Primary Outcome
Title Change in Serum Transferrin Levels From Baseline to 90 Days
Hide Description [Not Specified]
Time Frame Baseline, 30 days, 60 days, 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Only Prebiotic Inulin & Iron Salt FeSO4 Prebiotic GOS & Iron Salt FeSO4 Prebiotic Inulin & Iron Salt NaFeEDTA Prebiotic GOS & Iron Salt NaFeEDTA
Hide Arm/Group Description:
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Overall Number of Participants Analyzed 15 15 15 15 15
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline 16.84  (0.05) 16.74  (0.09) 16.38  (0.08) 16.79  (0.07) 17.15  (0.06)
30 days 16.74  (0.04) 16.63  (0.09) 16.30  (0.09) 16.69  (0.10) 16.97  (0.04)
60 days 16.55  (0.09) 16.52  (0.11) 16.21  (0.09) 16.59  (0.14) 16.69  (0.16)
90 days 16.44  (0.08) 16.41  (0.13) 16.09  (0.10) 16.46  (0.08) 16.47  (0.12)
10.Primary Outcome
Title Change in Transferrin Saturation Factor Levels From Baseline to 90 Days
Hide Description [Not Specified]
Time Frame Baseline, 30 days, 60 days, 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Only Prebiotic Inulin & Iron Salt FeSO4 Prebiotic GOS & Iron Salt FeSO4 Prebiotic Inulin & Iron Salt NaFeEDTA Prebiotic GOS & Iron Salt NaFeEDTA
Hide Arm/Group Description:
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Overall Number of Participants Analyzed 15 15 15 15 15
Mean (Standard Deviation)
Unit of Measure: % Transferrin
Baseline 16.92  (0.20) 17.66  (0.24) 18.49  (0.19) 17.73  (0.14) 17.64  (0.10)
30 days 17.22  (0.23) 18.13  (0.32) 18.91  (0.23) 18.13  (0.19) 18.29  (0.13)
60 days 17.69  (0.19) 18.75  (0.38) 19.41  (0.27) 18.58  (0.26) 19.13  (0.16)
90 days 17.98  (0.20) 19.13  (0.42) 20.05  (0.30) 19.28  (0.33) 20.02  (0.27)
11.Primary Outcome
Title Change in Total Iron Binding Capacity Levels From Baseline to 90 Days
Hide Description [Not Specified]
Time Frame Baseline, 30 days, 60 days, 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Only Prebiotic Inulin & Iron Salt FeSO4 Prebiotic GOS & Iron Salt FeSO4 Prebiotic Inulin & Iron Salt NaFeEDTA Prebiotic GOS & Iron Salt NaFeEDTA
Hide Arm/Group Description:
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Overall Number of Participants Analyzed 15 15 15 15 15
Mean (Standard Deviation)
Unit of Measure: mcg/dL
Baseline 404.26  (1.16) 401.81  (2.12) 393.06  (1.93) 402.84  (1.68) 411.67  (1.53)
30 days 401.75  (1.07) 399.06  (2.19) 391.08  (2.06) 400.55  (1.72) 407.29  (1.61)
60 days 397.21  (2.16) 396.57  (2.62) 388.93  (2.09) 398.17  (1.63) 400.57  (1.52)
90 days 394.63  (2.04) 393.92  (3.17) 386.16  (2.30) 395.03  (1.95) 395.20  (1.75)
12.Secondary Outcome
Title Change in Liver Functions Tests (ALT) From Baseline to 90 Days
Hide Description [Not Specified]
Time Frame Baseline, 30 days, 60 days, 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Only Prebiotic Inulin & Iron Salt FeSO4 Prebiotic GOS & Iron Salt FeSO4 Prebiotic Inulin & Iron Salt NaFeEDTA Prebiotic GOS & Iron Salt NaFeEDTA
Hide Arm/Group Description:
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Overall Number of Participants Analyzed 15 15 15 15 15
Mean (Standard Deviation)
Unit of Measure: IU/L
Baseline ALT 10.51  (0.10) 11.80  (0.18) 15.18  (0.44) 14.73  (0.08) 11.59  (0.31)
30 days ALT 10.61  (0.23) 11.10  (0.35) 14.31  (0.52) 13.24  (0.45) 10.54  (0.56)
60 days ALT 10.59  (0.24) 10.69  (0.40) 12.85  (0.76) 12.32  (0.75) 9.75  (0.70)
90 days ALT 11.28  (0.60) 10.27  (0.40) 11.81  (0.84) 11.13  (0.89) 9.27  (0.66)
13.Secondary Outcome
Title Change in Liver Functions Tests (AST) From Baseline to 90 Days
Hide Description [Not Specified]
Time Frame Baseline, 30 days, 60 days, 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Only Prebiotic Inulin & Iron Salt FeSO4 Prebiotic GOS & Iron Salt FeSO4 Prebiotic Inulin & Iron Salt NaFeEDTA Prebiotic GOS & Iron Salt NaFeEDTA
Hide Arm/Group Description:
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Overall Number of Participants Analyzed 15 15 15 15 15
Mean (Standard Deviation)
Unit of Measure: IU/L
Baseline AST 16.83  (0.15) 15.93  (0.53) 18.07  (0.11) 18.77  (0.14) 16.09  (0.26)
30 days AST 16.81  (0.14) 15.76  (0.54) 17.13  (0.19) 18.90  (0.82) 15.99  (0.21)
60 days AST 16.68  (0.13) 15.73  (0.55) 17.04  (0.22) 18.80  (0.85) 15.87  (0.27)
90 days AST 16.55  (0.11) 15.62  (0.56) 16.84  (0.25) 18.78  (0.90) 15.75  (0.32)
14.Secondary Outcome
Title Change in Liver Functions Tests (ALP) From Baseline to 90 Days
Hide Description [Not Specified]
Time Frame Baseline, 30 days, 60 days, 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Only Prebiotic Inulin & Iron Salt FeSO4 Prebiotic GOS & Iron Salt FeSO4 Prebiotic Inulin & Iron Salt NaFeEDTA Prebiotic GOS & Iron Salt NaFeEDTA
Hide Arm/Group Description:
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Overall Number of Participants Analyzed 15 15 15 15 15
Mean (Standard Deviation)
Unit of Measure: IU/L
Baseline ALP 65.84  (1.54) 69.35  (0.76) 73.92  (1.33) 74.99  (1.25) 68.43  (1.31)
30 days ALP 65.63  (2.03) 71.07  (0.72) 73.77  (1.32) 74.86  (1.23) 68.37  (1.30)
60 days ALP 65.51  (1.41) 73.34  (0.73) 73.42  (1.36) 74.72  (1.24) 68.19  (1.24)
90 days ALP 65.48  (1.38) 76.06  (0.71) 73.14  (1.35) 74.55  (1.19) 68.12  (1.24)
15.Secondary Outcome
Title Change in Liver Functions Tests (Total Bilirubin) From Baseline to 90 Days
Hide Description [Not Specified]
Time Frame Baseline, 30 days, 60 days, 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Only Prebiotic Inulin & Iron Salt FeSO4 Prebiotic GOS & Iron Salt FeSO4 Prebiotic Inulin & Iron Salt NaFeEDTA Prebiotic GOS & Iron Salt NaFeEDTA
Hide Arm/Group Description:
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Overall Number of Participants Analyzed 15 15 15 15 15
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline Total Bilirubin 0.31  (0.02) 0.44  (0.02) 0.47  (0.02) 0.61  (0.05) 0.35  (0.03)
30 days Total Bilirubin 0.31  (0.03) 0.41  (0.03) 0.43  (0.03) 0.55  (0.07) 0.20  (0.04)
60 days Total Bilirubin 0.26  (0.04) 0.36  (0.05) 0.41  (0.04) 0.51  (0.08) 0.13  (0.05)
90 days Total Bilirubin 0.19  (0.06) 0.27  (0.07) 0.28  (0.07) 0.43  (0.06) 0.11  (0.03)
16.Secondary Outcome
Title Change in Renal Functions Tests (Serum Urea) From Baseline to 90 Days
Hide Description [Not Specified]
Time Frame Baseline, 30 days, 60 days, 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Only Prebiotic Inulin & Iron Salt FeSO4 Prebiotic GOS & Iron Salt FeSO4 Prebiotic Inulin & Iron Salt NaFeEDTA Prebiotic GOS & Iron Salt NaFeEDTA
Hide Arm/Group Description:
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Overall Number of Participants Analyzed 15 15 15 15 15
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline Serum Urea 18.86  (0.13) 17.59  (0.19) 19.60  (0.33) 21.02  (0.46) 21.55  (0.27)
30 days Serum Urea 18.53  (0.20) 17.77  (0.18) 19.63  (0.34) 21.01  (0.44) 21.56  (0.29)
60 days Serum Urea 18.23  (0.21) 17.86  (0.17) 19.65  (0.35) 21.06  (0.47) 21.59  (0.31)
90 days Serum Urea 18.01  (0.10) 17.92  (0.20) 19.10  (2.51) 21.04  (0.55) 21.65  (0.35)
17.Secondary Outcome
Title Change in Renal Functions Tests (Serum Creatinine) From Baseline to 90 Days
Hide Description [Not Specified]
Time Frame Baseline, 30 days, 60 days, 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Only Prebiotic Inulin & Iron Salt FeSO4 Prebiotic GOS & Iron Salt FeSO4 Prebiotic Inulin & Iron Salt NaFeEDTA Prebiotic GOS & Iron Salt NaFeEDTA
Hide Arm/Group Description:
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Overall Number of Participants Analyzed 15 15 15 15 15
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline Serum Creatinine 0.77  (0.02) 0.83  (0.02) 0.89  (0.01) 0.62  (0.02) 0.65  (0.02)
30 days Serum Creatinine 0.76  (0.03) 0.86  (0.03) 0.93  (0.02) 0.70  (0.04) 0.74  (0.03)
60 days Serum Creatinine 0.78  (0.03) 0.90  (0.03) 0.95  (0.02) 0.77  (0.05) 0.84  (0.05)
90 days Serum Creatinine 0.80  (0.02) 0.93  (0.03) 0.92  (0.03) 0.86  (0.06) 0.94  (0.03)
18.Secondary Outcome
Title Change in Immunoglobulins (IgA) From Baseline to 90 Days
Hide Description [Not Specified]
Time Frame Baseline, 30 days, 60 days, 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Only Prebiotic Inulin & Iron Salt FeSO4 Prebiotic GOS & Iron Salt FeSO4 Prebiotic Inulin & Iron Salt NaFeEDTA Prebiotic GOS & Iron Salt NaFeEDTA
Hide Arm/Group Description:
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Overall Number of Participants Analyzed 15 15 15 15 15
Mean (Standard Deviation)
Unit of Measure: g/dL
Baseline IgA 200.91  (0.66) 214.75  (1.39) 210.56  (1.26) 204.54  (1.31) 199.97  (1.34)
30 days IgA 201.09  (0.98) 212.33  (1.82) 207.42  (2.34) 201.29  (2.95) 194.84  (2.56)
60 days IgA 198.97  (1.05) 209.24  (2.06) 203.48  (4.55) 198.56  (2.99) 191.90  (3.65)
90 days IgA 196.23  (1.20) 205.58  (2.75) 200.37  (4.67) 195.68  (3.22) 186.22  (3.65)
19.Secondary Outcome
Title Change in Immunoglobulins (IgE) From Baseline to 90 Days
Hide Description [Not Specified]
Time Frame Baseline, 30 days, 60 days, 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Only Prebiotic Inulin & Iron Salt FeSO4 Prebiotic GOS & Iron Salt FeSO4 Prebiotic Inulin & Iron Salt NaFeEDTA Prebiotic GOS & Iron Salt NaFeEDTA
Hide Arm/Group Description:
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Overall Number of Participants Analyzed 15 15 15 15 15
Mean (Standard Deviation)
Unit of Measure: IU/mL
Baseline IgE 195.02  (1.06) 184.86  (1.14) 186.02  (2.81) 174.62  (1.59) 193.76  (1.49)
30 days IgE 192.59  (1.34) 181.87  (2.19) 182.36  (3.44) 171.73  (2.63) 189.69  (2.47)
60 days IgE 190.81  (1.32) 179.00  (2.63) 178.23  (3.79) 168.62  (3.31) 185.56  (2.83)
90 days IgE 187.32  (1.39) 176.28  (3.49) 174.09  (3.50) 164.60  (3.98) 177.73  (3.90)
20.Secondary Outcome
Title Change in Immunoglobulins (IgG) From Baseline to 90 Days
Hide Description [Not Specified]
Time Frame Baseline, 30 days, 60 days, 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Only Prebiotic Inulin & Iron Salt FeSO4 Prebiotic GOS & Iron Salt FeSO4 Prebiotic Inulin & Iron Salt NaFeEDTA Prebiotic GOS & Iron Salt NaFeEDTA
Hide Arm/Group Description:
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Overall Number of Participants Analyzed 15 15 15 15 15
Mean (Standard Deviation)
Unit of Measure: g/dL
Baseline IgG 1684.10  (2.39) 1718.47  (3.49) 1734.16  (2.61) 1691.93  (2.76) 1707.56  (2.14)
30 days IgG 1681.23  (2.12) 1708.98  (5.18) 1727.20  (3.66) 1687.67  (3.06) 1684.95  (2.32)
60 days IgG 1678.54  (2.46) 1704.64  (5.80) 1719.79  (4.51) 1682.53  (4.26) 1655.01  (2.39)
90 days IgG 1674.86  (1.86) 1700.06  (6.47) 1711.76  (4.32) 1678.98  (5.66) 1622.73  (2.45)
21.Secondary Outcome
Title Change in Immunoglobulins (IgM) From Baseline to 90 Days
Hide Description [Not Specified]
Time Frame Baseline, 30 days, 60 days, 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Only Prebiotic Inulin & Iron Salt FeSO4 Prebiotic GOS & Iron Salt FeSO4 Prebiotic Inulin & Iron Salt NaFeEDTA Prebiotic GOS & Iron Salt NaFeEDTA
Hide Arm/Group Description:
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Overall Number of Participants Analyzed 15 15 15 15 15
Mean (Standard Deviation)
Unit of Measure: g/dL
Baseline IgM 303.66  (2.51) 285.20  (2.57) 273.74  (2.20) 267.76  (3.05) 256.37  (1.69)
30 days IgM 300.55  (2.51) 281.25  (2.36) 271.15  (2.31) 264.41  (3.05) 234.41  (1.87)
60 days IgM 299.38  (2.51) 278.21  (2.59) 267.81  (2.83) 259.83  (3.23) 213.71  (2.28)
90 days IgM 296.90  (2.51) 271.64  (2.93) 264.02  (3.15) 256.95  (3.16) 203.21  (3.43)
Time Frame 3 months
Adverse Event Reporting Description The participants were regularly asked if they developed constipation. diarrhea or bloating during the study period, however no one developed such symptoms.
 
Arm/Group Title Placebo Only Prebiotic Inulin & Iron Salt NaFeEDTA Prebiotic Inulin & Iron Salt NaFeEDTA (2) Prebiotic Inulin & Iron Salt FeS04 Prebiotic GOS & Iron Salt NaFeEDTA
Hide Arm/Group Description Prebiotic + Iron Forificant: A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects. Prebiotic + Iron Forificant: A combination dosage of 963 mg/kg Inulin and 10 ppm NaFeEDTA was given to the study subjects. Prebiotic + Iron Forificant: A combination dosage of 963 mg/kg Inulin and 20 ppm NaFeEDTA was given to the study subjects. Prebiotic + Iron Forificant: A combination dosage of 963 mg/kg Inulin and 30 ppm FeSO4 was given to the study subjects. Prebiotic + Iron Forificant: A combination dosage of 963 mg/kg GOS and 20 ppm NaFeEDTA was given to the study subjects.
All-Cause Mortality
Placebo Only Prebiotic Inulin & Iron Salt NaFeEDTA Prebiotic Inulin & Iron Salt NaFeEDTA (2) Prebiotic Inulin & Iron Salt FeS04 Prebiotic GOS & Iron Salt NaFeEDTA
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/15 (0.00%)   0/15 (0.00%)   0/15 (0.00%)   0/15 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Only Prebiotic Inulin & Iron Salt NaFeEDTA Prebiotic Inulin & Iron Salt NaFeEDTA (2) Prebiotic Inulin & Iron Salt FeS04 Prebiotic GOS & Iron Salt NaFeEDTA
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/15 (0.00%)   0/15 (0.00%)   0/15 (0.00%)   0/15 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Only Prebiotic Inulin & Iron Salt NaFeEDTA Prebiotic Inulin & Iron Salt NaFeEDTA (2) Prebiotic Inulin & Iron Salt FeS04 Prebiotic GOS & Iron Salt NaFeEDTA
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/15 (0.00%)   0/15 (0.00%)   0/15 (0.00%)   0/15 (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.
The research is the property of the University and we have signed an Intellectual Property Rights agreement whereby we will not disclose the study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Waqas Ahmed
Organization: University of Veterinary & Animal Sciences, Lahore, Pakistan
Phone: 0092-42-99211449 ext 296
EMail: waqas.niaz@uvas.edu.pk
Layout table for additonal information
Responsible Party: ABDUL MOMIN RIZWAN AHMAD, University of Veterinary and Animal Sciences, Lahore - Pakistan
ClinicalTrials.gov Identifier: NCT03894449     History of Changes
Other Study ID Numbers: 2015-VA-04
First Submitted: March 25, 2019
First Posted: March 28, 2019
Results First Submitted: July 13, 2019
Results First Posted: August 22, 2019
Last Update Posted: August 22, 2019