Efficacy of a Milk-based Nutrient-rich Bar on Nutritional Status and Cognitive Performance of School Children in Vietnam
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 415
- Locations
- 1
- Primary Endpoint
- micronutrient status
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 6 Years to 10 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
micronutrient enriched bar
bar enriched with micronutrients
Intervention: food bar (Dietary Supplement)
control arm
normal bar
Intervention: food bar (Dietary Supplement)
Outcomes
Primary Outcomes
micronutrient status
Time Frame: 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 Outcomes
- cognitive function(6 months intervention study with baseline and endpoint data collection)
Investigators
Frank Wieringa
Senior Researcher
Institut de Recherche pour le Developpement