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

NCT ID: NCT01491581

Last Updated: 2012-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

415 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2012-10-31

Brief Summary

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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

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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.

Conditions

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Cognitive Performance

Keywords

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anthropometry zinc iodine vitamin D calcium school children food supplement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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micronutrient enriched bar

bar enriched with micronutrients

Group Type EXPERIMENTAL

food bar

Intervention Type DIETARY_SUPPLEMENT

milk based food bar enriched with micronutrients

control arm

normal bar

Group Type PLACEBO_COMPARATOR

food bar

Intervention Type DIETARY_SUPPLEMENT

milk based food bar enriched with micronutrients

Interventions

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food bar

milk based food bar enriched with micronutrients

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Goody

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Can Tho University

OTHER

Sponsor Role collaborator

National Institute of Nutrition, Vietnam

OTHER_GOV

Sponsor Role collaborator

Global Alliance for Improved Nutrition

OTHER

Sponsor Role collaborator

ILSI, Japan

UNKNOWN

Sponsor Role collaborator

Institut de Recherche pour le Developpement

OTHER_GOV

Sponsor Role lead

Responsible Party

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Frank Wieringa

Senior Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Can Do primary school

Can Do, Can Tho City, Vietnam

Site Status

Countries

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Vietnam

Other Identifiers

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VietnamSchoolBar_2011

Identifier Type: -

Identifier Source: org_study_id