Efficacy of Multiple Micronutrient Fortified Biscuits and Deworming in Vietnamese School Children

Phase 2

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: worm treatment and multiple micronutrient fortified biscuits

• Registration Number: NCT00728273
• Lead Sponsor: Neys-van Hoogstraten Foundation, The Netherlands

Brief Summary

The aim of this study is to identify the effect of a school-based food fortification intervention with multi-micronutrients with or without deworming to improve anemia, micronutrient status, cognitive function, health (morbidity and reinfestation rate) and growth (ponderal) in Vietnamese primary schoolchildren.

Detailed Description

Concurrent micronutrient deficiencies are prevalent in schoolchildren in Vietnam. These deficiencies not only lead to anemia, impair growth, increase susceptibility to infection, impair work capacity, but also impair cognitive development and impair learning ability. The risk of micronutrient deficiencies and anemia increases when individuals are exposed to intestinal helminth infections. Schoolchildren are a neglected group with regard to micronutrient interventions, and school programs afford an excellent opportunity to improve health of these groups. Food fortification with multi-micronutrients is a cost-effective and sustainable strategy, but is not yet implemented on a large scale in Vietnam. Furthermore, little is known about whether high prevalence of intestinal helminthic infection in schoolchildren limits the effect of fortification when this is not combined with regular de-worming.

Study Timeline

• Study Start: 2007-01
• Primary Completion: 2007-01
• Study Completion: 2007-06
• Study First Submitted: 2008-07-30
• Study First Submitted QC: 2008-07-31
• Study First Posted: 2008-08-05
• Status Verified: 2008-11
• Last Update Submitted: 2008-12-03
• Last Update Posted: 2008-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 510

Inclusion Criteria

• school children aged 6-8 years with written informed consent from parents/caregivers

Exclusion Criteria

• hemoglobin concentrations < 80g/L
• chronic disease
• congenital abnormalities
• mental or severe physical handicap
• severe malnutrition
• obesity
• receiving deworming within the previous 6 mo

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
MMF	worm treatment and multiple micronutrient fortified biscuits	multi-micronutrient-fortified biscuit plus placebo deworming-treatment
Alb	worm treatment and multiple micronutrient fortified biscuits	placebo biscuit plus deworming treatment with Albendazole
MMF + Alb	worm treatment and multiple micronutrient fortified biscuits	multiple micronutrient-fortified biscuits with deworming treatment with Albendazole
placebo	worm treatment and multiple micronutrient fortified biscuits	placebo biscuit (non-fortified) and placebo deworming treatment

Primary Outcome Measures

Name	Time	Method
Prevalence of anemia, micronutrient status (iron, vitamin A, zinc, and iodine), and cognitive function (attention, IQ, concentration, and school achievement).	4 months

Secondary Outcome Measures

Name	Time	Method
prevalence and incidence of infectious diseases such as diarrhea and respiratory infection over a 4-month period during the school feeding in	4 months
growth (especially weight), body composition (body fat)	4 months

Trial Locations

Locations (1)

Institute of Nutrition, Mahidol University; 🇹🇭 Nakhon Pathom, Thailand