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

This study has been completed.
Sponsor:
Collaborators:
Can Tho University
National Institute of Nutrition, Ministry of Health, Vietnam
GAIN, Geneva, Switzerland
ILSI, Japan
Information provided by (Responsible Party):
Frank Wieringa, Institut de Recherche pour le Developpement
ClinicalTrials.gov Identifier:
NCT01491581
First received: November 28, 2011
Last updated: November 20, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
Cognitive Performance
Dietary Supplement: food bar

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Efficacy of a Milk-based Nutrient-rich Bar on Nutritional Status and Cognitive Performance of School Children in Vietnam

Resource links provided by NLM:


Further study details as provided by Institut de Recherche pour le Developpement:

Primary Outcome Measures:
  • micronutrient status [ Time Frame: 6 months intervention study with baseline and endpoint data collection ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • cognitive function [ Time Frame: 6 months intervention study with baseline and endpoint data collection ] [ Designated as safety issue: No ]
    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


Enrollment: 415
Study Start Date: December 2011
Study Completion Date: October 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: micronutrient enriched bar
bar enriched with micronutrients
Dietary Supplement: food bar
milk based food bar enriched with micronutrients
Other Name: Goody
Placebo Comparator: control arm
normal bar
Dietary Supplement: food bar
milk based food bar enriched with micronutrients
Other Name: Goody

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.

  Eligibility

Ages Eligible for Study:   6 Years to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01491581

Locations
Vietnam
Can Do primary school
Can Do, Can Tho, Vietnam
Sponsors and Collaborators
Institut de Recherche pour le Developpement
Can Tho University
National Institute of Nutrition, Ministry of Health, Vietnam
GAIN, Geneva, Switzerland
ILSI, Japan
  More Information

No publications provided

Responsible Party: Frank Wieringa, Senior Researcher, Institut de Recherche pour le Developpement
ClinicalTrials.gov Identifier: NCT01491581     History of Changes
Other Study ID Numbers: VietnamSchoolBar_2011
Study First Received: November 28, 2011
Last Updated: November 20, 2012
Health Authority: Vietnam: Ministry of Health

Keywords provided by Institut de Recherche pour le Developpement:
anthropometry
zinc
iodine
vitamin D
calcium
school children
food supplement

Additional relevant MeSH terms:
Micronutrients
Trace Elements
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014