Efficacy of a Milk-based Nutrient-rich Bar on Nutritional Status and Cognitive Performance of School Children in Vietnam

Study Overview
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Brief Summary
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The objective of the study is to evaluate the impact of the milk-based nutrient-rich bar, specifically the effect of its fortification with zinc, iodine, vitamins A and D and calcium on nutritional status of school children, focusing on vitamin A and, zinc, iodine, calcium and iron status, and on their cognitive performances.

Detailed Description
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Design: double-masked randomized control trial Place: three schools in South Vietnam, Can Tho district, South Vietnam Subjects: School children aged 6 to 10 years old, from first grade to third grade of 3 primary schools. Duration of intervention: 6 months (consumption of Goody or control bar) Study groups: 2 groups: Group 1: children will receive micronutrient enriched milk bar. Group 2: children will receive the same milk-based food except for the micronutrient fortification.

Official Title
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Efficacy of a Milk-based Nutrient-rich Bar on Nutritional Status and Cognitive Performance of School Children in Vietnam

Conditions
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Cognitive Performance

Intervention / Treatment
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* Dietary Supplement: food bar


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: pupil in one of the 2 selected schools, in grade 1 - 3 weight for height > -3 z-scores hemoglobin concentration > 70 g/L Exclusion Criteria: weight for height < -3 z-scores hemoglobin concentration <= 70 g/L

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: micronutrient enriched bar<br>bar enriched with micronutrients | Dietary Supplement: food bar<br>* milk based food bar enriched with micronutrients<br>* Other names: Goody;|
| Placebo Comparator: control arm<br>normal bar | Dietary Supplement: food bar<br>* milk based food bar enriched with micronutrients<br>* Other names: Goody;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| micronutrient status | change in micronutrient status (hemoglobin and serum concentrations of vitamin D, calium, zinc) from baseline to end of the intervention when children have received the food bar for 6 months, 5 days/week. | 6 months intervention study with baseline and endpoint data collection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cognitive function | change in cognitive function (as measured by Raven's test) in children from baseline to end point, when the children have received 6 months of food bar, 5 days/week | 6 months intervention study with baseline and endpoint data collection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anthropometry, zinc, iodine, vitamin D, calcium, school children, food supplement