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

Efficacy of Multiple Micronutrient Fortified Biscuits and Deworming on Reducing Anemia Prevalence, and Improving Micronutrient Status, Cognitive Function, and Growth 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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: worm treatment and multiple micronutrient fortified biscuits

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 Type: Interventional
• Enrollment (Actual): 510
• Phase: Phase 2

Contacts and Locations

Study Locations

• Thailand
  • Nakhon Pathom, Thailand, 73170
    • Institute of Nutrition, Mahidol University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 8 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MMF; multi-micronutrient-fortified biscuit plus placebo deworming-treatment	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.; Other Names: Vidoca (Thephaco, Vietnam)
Experimental: Alb; placebo biscuit plus deworming treatment with Albendazole	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.; Other Names: Vidoca (Thephaco, Vietnam)
Experimental: MMF + Alb; multiple micronutrient-fortified biscuits with deworming treatment with Albendazole	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.; Other Names: Vidoca (Thephaco, Vietnam)
Placebo Comparator: placebo; placebo biscuit (non-fortified) and placebo deworming treatment	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.; Other Names: Vidoca (Thephaco, Vietnam)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Neys-van Hoogstraten Foundation, The Netherlands
• Investigators: Principal Investigator: Pattanee Winichagoon, PhD, Institute of Nutrition, Mahidol University, Nakhon Pathom, Thailand

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Actual): January 1, 2007
• Study Completion (Actual): June 1, 2007

Study Registration Dates

• First Submitted: July 30, 2008
• First Submitted That Met QC Criteria: July 31, 2008
• First Posted (Estimate): August 5, 2008

Study Record Updates

• Last Update Posted (Estimate): December 4, 2008
• Last Update Submitted That Met QC Criteria: December 3, 2008
• Last Verified: November 1, 2008

More Information

Terms related to this study

• Keywords: Efficacy; anemia; Vietnam; fortification; micronutrient; school children
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Micronutrients; Trace Elements
• Other Study ID Numbers: Neys-code VT 188