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Completed

NCT Number: NCT01491581

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

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.

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Key information

Conditions

Cognitive Performance

Age range

6 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Can Do primary school

Can Do, Can Tho City, Vietnam

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

food bar

Dietary Supplement

milk based food bar enriched with micronutrients

Other names: Goody

Primary outcomes

  1. 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

  1. cognitive function

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Institut de Recherche pour le Developpement

Other Gov

Collaborators

  • Can Tho University
  • Global Alliance for Improved Nutrition
  • ILSI, Japan
  • National Institute of Nutrition, Vietnam

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Dec 14, 2011
Registry last updated
Nov 21, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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