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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: worm treatment and multiple micronutrient fortified biscuits


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MMF<br>multi-micronutrient-fortified biscuit plus placebo deworming-treatment | Dietary Supplement: worm treatment and multiple micronutrient fortified biscuits<br>* 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.<br>* Other names: Vidoca (Thephaco, Vietnam);|
| Experimental: Alb<br>placebo biscuit plus deworming treatment with Albendazole | Dietary Supplement: worm treatment and multiple micronutrient fortified biscuits<br>* 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.<br>* Other names: Vidoca (Thephaco, Vietnam);|
| Experimental: MMF + Alb<br>multiple micronutrient-fortified biscuits with deworming treatment with Albendazole | Dietary Supplement: worm treatment and multiple micronutrient fortified biscuits<br>* 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.<br>* Other names: Vidoca (Thephaco, Vietnam);|
| Placebo Comparator: placebo<br>placebo biscuit (non-fortified) and placebo deworming treatment | Dietary Supplement: worm treatment and multiple micronutrient fortified biscuits<br>* 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.<br>* Other names: Vidoca (Thephaco, Vietnam);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Efficacy, Vietnam, school children, anemia, fortification, micronutrient