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

NCT00728273 | Completed Phase 2

• 1 other identifier: Neys-code VT 188
• Study Type: interventional
• Target: 510
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Efficacy; Vietnam; school children; anemia; fortification; micronutrient

Outcome Measures

Primary Outcomes (1)

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

  4 months

Secondary Outcomes (2)

• growth (especially weight), body composition (body fat)

  4 months

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

  4 months

Study Arms (4)

MMF

EXPERIMENTAL

multi-micronutrient-fortified biscuit plus placebo deworming-treatment

Dietary Supplement: worm treatment and multiple micronutrient fortified biscuits

Alb

EXPERIMENTAL

placebo biscuit plus deworming treatment with Albendazole

Dietary Supplement: worm treatment and multiple micronutrient fortified biscuits

MMF + Alb

EXPERIMENTAL

multiple micronutrient-fortified biscuits with deworming treatment with Albendazole

Dietary Supplement: worm treatment and multiple micronutrient fortified biscuits

placebo

PLACEBO COMPARATOR

placebo biscuit (non-fortified) and placebo deworming treatment

Dietary Supplement: worm treatment and multiple micronutrient fortified biscuits

Interventions

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.

Also known as: Vidoca (Thephaco, Vietnam)

Alb; MMF; MMF + Alb; placebo

Eligibility Criteria

• Age: 6 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Neys-van Hoogstraten Foundation, The Netherlands: lead

Study Sites (1)

Institute of Nutrition, Mahidol University

Nakhon Pathom, 73170, Thailand

Location

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Pattanee Winichagoon, PhD

  Institute of Nutrition, Mahidol University, Nakhon Pathom, Thailand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 30, 2008
• First Posted: August 5, 2008
• Study Start: January 1, 2007
• Primary Completion: January 1, 2007
• Study Completion: June 1, 2007
• Last Updated: December 4, 2008

Record last verified: 2008-11

Locations

TH (1)