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

Not Applicable

Completed

• Conditions: Cognitive Performance
• Interventions: Dietary Supplement: food bar

• Registration Number: NCT01491581
• Lead Sponsor: Institut de Recherche pour le Developpement

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2011-11-28
• Study Start: 2011-12
• Study First Submitted QC: 2011-12-12
• Study First Posted: 2011-12-14
• Primary Completion: 2012-05
• Study Completion: 2012-10
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-20
• Last Update Posted: 2012-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 415

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
micronutrient enriched bar	food bar	bar enriched with micronutrients
control arm	food bar	normal bar

Primary Outcome Measures

Name	Time	Method
micronutrient status	6 months intervention study with baseline and endpoint data collection	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.

Secondary Outcome Measures

Name	Time	Method
cognitive function	6 months intervention study with baseline and endpoint data collection	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

Trial Locations

Locations (1)

Can Do primary school; 🇻🇳 Can Do, Can Tho, Vietnam