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Completed

NCT Number: NCT00728273

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

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.

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Key information

Conditions

Healthy Anemia Hematologic Diseases Hemic and Lymphatic Diseases

Age range

6 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Institute of Nutrition, Mahidol University

Nakhon Pathom, 73170, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

worm treatment and multiple micronutrient fortified biscuits

Dietary Supplement

A single dose of intestinal anthelminthic treatment as orange-flavored chewable tablets containing 400 mg Albendazole (Vidoca, Thephaco, Vietnam) was given. Deworming was repeated with Albendazole for all children at the end of the study (after 4 months).

The composition and amount of nutrients in each serving of fortified biscuit were 6 mg iron, 5.6 mg zinc, 35µg iodine, 300 µg RAE vitamin A, 1.0 mg thiamin, 0.9 mg riboflavin, 1.1 mg vitamin B6, 10.5 mg NE niacin, 1.5 µg vitamin B12, 120 µg folic acid, 28 mg vitamin C, 150 mg calcium, 74 IU vitamin D, 40 mg magnesium, 6.8 µg selenium, 378 mg potassium, 70 mg phosphorus, 3.0 mg pantothenic acid, 2.8 µg vitamin E, 10 µg vitamin K and 18 µg biotin.

Other names: Vidoca (Thephaco, Vietnam)

Primary outcomes

  1. Prevalence of anemia, micronutrient status (iron, vitamin A, zinc, and iodine), and cognitive function (attention, IQ, concentration, and school achievement).

    Time frame: 4 months

Secondary outcomes

  1. growth (especially weight), body composition (body fat)

    Time frame: 4 months

  2. prevalence and incidence of infectious diseases such as diarrhea and respiratory infection over a 4-month period during the school feeding in

    Time frame: 4 months

Sponsors and collaborators

Lead sponsor

Neys-van Hoogstraten Foundation, The Netherlands

Other

Registry information

Official study title

Efficacy of Multiple Micronutrient Fortified Biscuits and Deworming on Reducing Anemia Prevalence, and Improving Micronutrient Status, Cognitive Function, and Growth in Vietnamese School Children

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Aug 5, 2008
Registry last updated
Dec 4, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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