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.

Study Overview

• Status: Completed
• Conditions: Cognitive Performance
• Intervention / Treatment: Dietary supplement: food bar

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.

• Study Type: Interventional
• Enrollment (Actual): 415
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Vietnam
  • Can Tho
    • Can Do, Can Tho, Vietnam
      • Can Do primary school

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: micronutrient enriched bar; bar enriched with micronutrients	Dietary supplement: food bar; milk based food bar enriched with micronutrients; Other Names: Goody
Placebo Comparator: control arm; normal bar	Dietary supplement: food bar; milk based food bar enriched with micronutrients; Other Names: Goody

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
micronutrient status	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.	6 months intervention study with baseline and endpoint data collection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cognitive function	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	6 months intervention study with baseline and endpoint data collection

Collaborators and Investigators

• Sponsor: Institut de Recherche pour le Developpement
• Collaborators: Global Alliance for Improved Nutrition; National Institute of Nutrition, Vietnam; Can Tho University; ILSI, Japan

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: November 28, 2011
• First Submitted That Met QC Criteria: December 12, 2011
• First Posted (Estimate): December 14, 2011

Study Record Updates

• Last Update Posted (Estimate): November 21, 2012
• Last Update Submitted That Met QC Criteria: November 20, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: zinc; food supplement; vitamin D; iodine; calcium; anthropometry; school children
• Other Study ID Numbers: VietnamSchoolBar_2011