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| Name | Class |
|---|---|
| St. John's Research Institute | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-Fortified Control Product | Placebo Comparator | Non-fortified control beverage |
|
| Micronutrient Fortified Test Product | Active Comparator | Micronutrient fortified test beverage |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-Fortified Control Product | Other | Non-Fortified Control Beverage |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the micronutrient status in the study subjects at 6 months | The primary outcome measures will be change from baseline in the micronutrient status in the study subjects at end of intervention. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in cognitive performance at 6 months | Change from baseline in cognitive test scores at the end of the intervention for all subjects. | 6 months |
| Change from baseline in the physical performance at 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Prashanth Thankachan, PhD | St. John's Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Johns Research Institute | Bangalore | Karnataka | 560034 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25746819 | Derived | Kuriyan R, Thankachan P, Selvam S, Pauline M, Srinivasan K, Kamath-Jha S, Vinoy S, Misra S, Finnegan Y, Kurpad AV. The effects of regular consumption of a multiple micronutrient fortified milk beverage on the micronutrient status of school children and on their mental and physical performance. Clin Nutr. 2016 Feb;35(1):190-198. doi: 10.1016/j.clnu.2015.02.001. Epub 2015 Feb 21. |
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| Micronutrient Fortified Test Product |
| Other |
Micronutrient Fortified Test Beverage |
|
Change from baseline in the physical test scores at end of intervention for all subjects
| 6 months |
| Change from baseline in the fatigue score at 6 months | Change from baseline in the fatigue score at end of intervention for all subjects | Baseline and Endline (six months) |
| Morbidity Assessment | Morbidity will be recorded on a weekly basis from the start until the end of the intervention | 6 months |
| Prevalence of Micronutrient Deficiency | Prevalence of micronutrient deficiency in each study arm at the end the intervention | 6 months |
| Change from baseline in anthropometric scores at 6 months | 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 | 6 months |