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

Cognitive Performance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01491581
• Other study ID #: VietnamSchoolBar_2011
• Status: Completed
• Phase: N/A
• First received: November 28, 2011
• Last updated: November 20, 2012
• Start date: December 2011
• Est. completion date: October 2012

Study information

• Verified date: November 2012
• Source: Institut de Recherche pour le Developpement
• Contact: n/a
• Is FDA regulated: No
• Health authority: Vietnam: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 415
• Est. completion date: October 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 10 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cognitive Performance

Intervention

Dietary Supplement:
• food bar
milk based food bar enriched with micronutrients

Locations

Country	Name	City	State
Vietnam	Can Do primary school	Can Do	Can Tho

Sponsors (5)

Lead Sponsor	Collaborator
Institut de Recherche pour le Developpement	Can Tho University, GAIN, Geneva, Switzerland, ILSI, Japan, National Institute of Nutrition, Vietnam

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No