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

Healthy Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00728273
• Other study ID #: Neys-code VT 188
• Status: Completed
• Phase: Phase 2
• First received: July 30, 2008
• Last updated: December 3, 2008
• Start date: January 2007
• Est. completion date: June 2007

Study information

• Verified date: November 2008
• Source: Neys-van Hoogstraten Foundation, The Netherlands
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 510
• Est. completion date: June 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 8 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• worm treatment and multiple micronutrient fortified biscuits
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.

Locations

Country	Name	City	State
Thailand	Institute of Nutrition, Mahidol University	Nakhon Pathom

Sponsors (1)

Lead Sponsor	Collaborator
Neys-van Hoogstraten Foundation, The Netherlands

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of anemia, micronutrient status (iron, vitamin A, zinc, and iodine), and cognitive function (attention, IQ, concentration, and school achievement).		4 months	Yes
Secondary	growth (especially weight), body composition (body fat)		4 months	Yes
Secondary	prevalence and incidence of infectious diseases such as diarrhea and respiratory infection over a 4-month period during the school feeding in		4 months	Yes