Efficacy of Multiple Micronutrient Fortified Biscuits and Deworming in Vietnamese School Children
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Healthy |
Dietary Supplement: worm treatment and multiple micronutrient fortified biscuits |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver, 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 |
- Prevalence of anemia, micronutrient status (iron, vitamin A, zinc, and iodine), and cognitive function (attention, IQ, concentration, and school achievement). [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
- growth (especially weight), body composition (body fat) [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
- prevalence and incidence of infectious diseases such as diarrhea and respiratory infection over a 4-month period during the school feeding in [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
| Enrollment: | 510 |
| Study Start Date: | January 2007 |
| Study Completion Date: | June 2007 |
| Primary Completion Date: | January 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 Name: 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 Name: 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 Name: 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 Name: Vidoca (Thephaco, Vietnam)
|
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.
Eligibility| Ages Eligible for Study: | 6 Years to 8 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| Thailand | |
| Institute of Nutrition, Mahidol University | |
| Nakhon Pathom, Thailand, 73170 | |
| Principal Investigator: | Pattanee Winichagoon, PhD | Institute of Nutrition, Mahidol University, Nakhon Pathom, Thailand |
More Information
No publications provided
| Responsible Party: | Principal Investigator: Dr. Pattanee Winichagoon, Ph.D., Associate Professor, Institute of Nutrition, Mahidol University, Nakhon Pathom, Thailand, 73170. |
| ClinicalTrials.gov Identifier: | NCT00728273 History of Changes |
| Other Study ID Numbers: | Neys-code VT 188 |
| Study First Received: | July 30, 2008 |
| Last Updated: | December 3, 2008 |
| Health Authority: | Thailand: Ethical Committee |
Keywords provided by Neys-van Hoogstraten Foundation, The Netherlands:
|
Efficacy Vietnam school children |
anemia fortification micronutrient |
Additional relevant MeSH terms:
|
Albendazole Micronutrients Trace Elements Anticestodal Agents Antiplatyhelmintic Agents Anthelmintics Antiparasitic Agents Anti-Infective Agents Therapeutic Uses |
Pharmacologic Actions Antiprotozoal Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013