Efficacy of Multiple Micronutrient Fortified Biscuits and Deworming in Vietnamese School Children - Full Text View

Sponsor:	Neys-van Hoogstraten Foundation, The Netherlands
Information provided by:	Neys-van Hoogstraten Foundation, The Netherlands
ClinicalTrials.gov Identifier:	NCT00728273

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 II

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment, Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Anemia

U.S. FDA Resources

Further study details as provided by Neys-van Hoogstraten Foundation, The Netherlands:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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
MMF: Experimental 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.
Alb: Experimental 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.
MMF + Alb: Experimental 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.
placebo: Placebo Comparator 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.

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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00728273

Locations

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

Sponsors and Collaborators

Neys-van Hoogstraten Foundation, The Netherlands

Investigators

Principal Investigator:

Pattanee Winichagoon, PhD

Institute of Nutrition, Mahidol University, Nakhon Pathom, Thailand

More Information

No publications provided

Responsible Party:	Institute of Nutrition, Mahidol University, Nakhon Pathom, Thailand, 73170. ( Principal Investigator: Dr. Pattanee Winichagoon, Ph.D., Associate Professor )
Study ID Numbers:	Neys-code VT 188
Study First Received:	July 30, 2008
Last Updated:	December 3, 2008
ClinicalTrials.gov Identifier:	NCT00728273 History of Changes
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:

Growth Substances
Physiological Effects of Drugs
Trace Elements
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010