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

French Public Scientific and Technological Institution (EPST)

Status: Completed

Conditions: Cognitive Performance

Treatments: Dietary Supplement: food bar

Study type: Interventional

Funder types: Other

Identifiers

NCT01491581

VietnamSchoolBar_2011

Details and patient eligibility

About

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.

Full 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.

Enrollment: 415 patients

Sex: All

Ages: 6 to 10 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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415 participants in 2 patient groups, including a placebo group

micronutrient enriched bar

Experimental group

Description:

bar enriched with micronutrients

Treatment:

Dietary Supplement: food bar

control arm

Placebo Comparator group

Description:

normal bar

Treatment:

Dietary Supplement: food bar