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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01491581
Enrollment
415
Registered
2011-12-14
Start date
2011-12-31
Completion date
2012-10-31
Last updated
2012-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Performance

Keywords

anthropometry, zinc, iodine, vitamin D, calcium, school children, food supplement

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.

Interventions

DIETARY_SUPPLEMENTfood bar

milk based food bar enriched with micronutrients

Sponsors

Can Tho University
CollaboratorOTHER
National Institute of Nutrition, Vietnam
CollaboratorOTHER_GOV
Global Alliance for Improved Nutrition
CollaboratorOTHER
ILSI, Japan
CollaboratorUNKNOWN
Institut de Recherche pour le Developpement
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
6 Years to 10 Years
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

Design outcomes

Primary

MeasureTime frameDescription
micronutrient status6 months intervention study with baseline and endpoint data collectionchange 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

MeasureTime frameDescription
cognitive function6 months intervention study with baseline and endpoint data collectionchange 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

Countries

Vietnam

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026