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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Other: Non-Fortified Control Product
* Other: Micronutrient Fortified Test Product


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Non-Fortified Control Product<br>Non-fortified control beverage | Other: Non-Fortified Control Product<br>* Non-Fortified Control Beverage<br>|
| Active Comparator: Micronutrient Fortified Test Product<br>Micronutrient fortified test beverage | Other: Micronutrient Fortified Test Product<br>* Micronutrient Fortified Test Beverage<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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micronutrient, healthy children, vitamins, minerals, cognition, physical performance, iron, Micronutrient status, Cognitive Performance