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

Sponsor

Neys-van Hoogstraten Foundation, The Netherlands (Other)

Overall Status

Completed

CT.gov ID

NCT00728273

Collaborator

(none)

510

Enrollment

Location

Arms

Duration (Months)

102.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Dietary Supplement: worm treatment and multiple micronutrient fortified biscuits	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

510 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

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

Study Start Date :

Jan 1, 2007

Actual Primary Completion Date :

Jan 1, 2007

Actual Study Completion Date :

Jun 1, 2007

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

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

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]