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

This study has been completed.
Sponsor:
Information provided by:
Neys-van Hoogstraten Foundation, The Netherlands
ClinicalTrials.gov Identifier:
NCT00728273
First received: July 30, 2008
Last updated: December 3, 2008
Last verified: November 2008
  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

Resource links provided by NLM:


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
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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: 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:
Micronutrients
Trace Elements
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014