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Effect of Regular Consumption of Micronutrient Fortified Beverage on the Micronutrient Status of Indian Schoolchildren

This study has been completed.
Sponsor:
Collaborator:
St. John's Research Institute
Information provided by (Responsible Party):
Mondelēz International, Inc.
ClinicalTrials.gov Identifier:
NCT01415557
First received: July 22, 2011
Last updated: November 5, 2013
Last verified: November 2013

July 22, 2011
November 5, 2013
August 2011
March 2012   (final data collection date for primary outcome measure)
Change from baseline in the micronutrient status in the study subjects at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
The primary outcome measures will be change from baseline in the micronutrient status in the study subjects at end of intervention.
Same as current
Complete list of historical versions of study NCT01415557 on ClinicalTrials.gov Archive Site
  • Change from baseline in cognitive performance at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Change from baseline in cognitive test scores at the end of the intervention for all subjects.
  • Change from baseline in the physical performance at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Change from baseline in the physical test scores at end of intervention for all subjects
  • Change from baseline in the fatigue score at 6 months [ Time Frame: Baseline and Endline (six months) ] [ Designated as safety issue: No ]
    Change from baseline in the fatigue score at end of intervention for all subjects
  • Morbidity Assessment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Morbidity will be recorded on a weekly basis from the start until the end of the intervention
  • Prevalence of Micronutrient Deficiency [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Prevalence of micronutrient deficiency in each study arm at the end the intervention
  • Change from baseline in anthropometric scores at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Change from baseline in anthropometric measures (Standardized (WHO, 2007) weight for age, height for age and BMI for age of the study subjects) at the end of the intervention
  • Change from baseline in cognitive performance at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Change from baseline in cognitive test scores at the end of the intervention for all subjects.
  • Change from baseline in the physical performance at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Change from baseline in the physical test scores at end of intervention for all subjects
  • Change from baseline in the fatigue score at 6 months [ Time Frame: Baseline and Endline (six months) ] [ Designated as safety issue: No ]
    Change from baseline in the fatigue score at end of intervention for all subjects
  • Morbidity Assessment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Morbity will be recorded on a weekly basis from the start until the end of the intervention
  • Prevalence of Micronutrient Deficiency [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Prevalence of micronutrient deficiency in each study arm at the end the intervention
  • Change from baseline in anthropometric scores at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Change from baseline in anthropometric measures (Standardized (WHO, 2007) weight for age, height for age and BMI for age of the study subjects) at the end of the intervention
Not Provided
Not Provided
 
Effect of Regular Consumption of Micronutrient Fortified Beverage on the Micronutrient Status of Indian Schoolchildren
The Effects of Regular Consumption of a Multiple Micronutrient Fortified Beverage on the Micronutrient Status of Indian Schoolchildren and on Their Mental and Physical Performance

The purpose of this study is to assess the impact of regular consumption of micronutrient fortified drink in improving nutritional and micronutrient status in Indian school children. The test beverage will be fortified with both, vitamins and minerals.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Healthy
  • Other: Non-Fortified Control Product
    Non-Fortified Control Beverage
  • Other: Micronutrient Fortified Test Product
    Micronutrient Fortified Test Beverage
  • Placebo Comparator: Non-Fortified Control Product
    Non-fortified control beverage
    Intervention: Other: Non-Fortified Control Product
  • Active Comparator: Micronutrient Fortified Test Product
    Micronutrient fortified test beverage
    Intervention: Other: Micronutrient Fortified Test Product
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
227
September 2012
March 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Apparently healthy school going children
  • not severely malnourished weight-for-height z-score ≥-2 not severely anemic (Hb<8g/dl)
  • Age: 7-10 years
  • Not taking any food supplements/fortified drinks
  • Not planning to move out during the study duration

Exclusion Criteria:

  • Age: <7 and >10 years
  • Severe anemia (Hb < 8 g/dl)
  • Severely malnourished children with weight-for-height z-score <-3 will be excluded.
  • Cardiovascular disease on clinical examination or history
  • Underlying respiratory disease with impairment of lung function
  • Physical disability which can interfere or limit performance of tests
  • Recent history (3 months prior) of serious infections, injuries and/ or surgeries
  • Any food allergy or food intolerance
  • Participation in any nutritional study in the last 1year
  • Children consuming nutritional supplements and/ or health food drinks
Both
7 Years to 10 Years
Yes
Contact information is only displayed when the study is recruiting subjects
India
 
NCT01415557
KFTSJRI2011
No
Mondelēz International, Inc.
Mondelēz International, Inc.
St. John's Research Institute
Principal Investigator: Prashanth Thankachan, PhD St. John's Research Institute
Mondelēz International, Inc.
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP