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

Neys-van Hoogstraten Foundation, The Netherlands

Status and phase: Completed; Phase 2

Conditions: Healthy

Treatments: Dietary Supplement: worm treatment and multiple micronutrient fortified biscuits

Study type: Interventional

Funder types: Other

Identifiers

NCT00728273

Neys-code VT 188

Details and patient eligibility

About

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.

Full 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.

Enrollment: 510 patients

Sex: All

Ages: 6 to 8 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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510 participants in 4 patient groups, including a placebo group

MMF

Experimental group

Description:

multi-micronutrient-fortified biscuit plus placebo deworming-treatment

Treatment:

Dietary Supplement: worm treatment and multiple micronutrient fortified biscuits

Alb

Experimental group

Description:

placebo biscuit plus deworming treatment with Albendazole

Treatment:

Dietary Supplement: worm treatment and multiple micronutrient fortified biscuits

MMF + Alb

Experimental group

Description:

multiple micronutrient-fortified biscuits with deworming treatment with Albendazole

Treatment:

Dietary Supplement: worm treatment and multiple micronutrient fortified biscuits

placebo

Placebo Comparator group

Description:

placebo biscuit (non-fortified) and placebo deworming treatment

Treatment:

Dietary Supplement: worm treatment and multiple micronutrient fortified biscuits