Effects of Vitamin A Supplementation on Intestinal Parasitic Reinfections - Full Text View

Sponsor:	Sana'a University
Collaborators:	University of Malaya Ministry of Health, Malaysia
Information provided by:	Sana'a University
ClinicalTrials.gov Identifier:	NCT00936091

Purpose

Intestinal parasitic infections, malnutrition and iron deficiency anaemia (IDA) are still considered as public health problems in rural Malaysia especially among Orang Asli children. Despite intermittent control programmes, the prevalence of these problems is still high suggesting the need of other control and interventions measures. This randomized double-blind, placebo-controlled trial was carried out among Orang Asli schoolchildren from Sekolah Kebangsaan Betau in Pos Betau, Pahang (200 km northeast Kuala Lumpur) to investigate the effects of vitamin A supplementation on intestinal parasitic reinfections, growth, iron status and educational achievement.

HYPOTHESES

Vitamin A supplementation has a negative effect on intestinal parasitic reinfections and the worm burden of infections among Orang Asli schoolchildren in Pos Betau, Kuala Lipis, Pahang.
Vitamin A supplementation has a positive effect on growth (weight and height) among Orang Asli schoolchildren.
Vitamin A supplementation is effective in improving serum iron status among Orang Asli schoolchildren.
Vitamin A supplementation has a positive effect on cognitive function and educational achievement among Orang Asli schoolchildren.

Condition	Intervention
Intestinal Parasitic Infections Malnutrition Anemia	Drug: vitamin A supplements Drug: Placebo

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention
Official Title:	Effects of Vitamin A Supplementation on Intestinal Parasitic Reinfections, Growth, Iron Status and Educational Achievement Among Orang Asli Schoolchildren in Pos Betau, Pahang, Malaysia

Resource links provided by NLM:

MedlinePlus related topics: Anemia Dietary Supplements Iron Malnutrition Parasitic Diseases Vitamin A

Drug Information available for: Retinol Vitamin A

U.S. FDA Resources

Further study details as provided by Sana'a University:

Primary Outcome Measures:

intestinal parasitic infections [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

growth , iron status & educational achievement [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment:	250
Study Start Date:	May 2007
Study Completion Date:	August 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: placebo 125 schoolchildren were allocated randomly to receive placebo	Drug: Placebo 125 children received placebo capsules Other Name: Group A
Active Comparator: vitamin A supplement 125 children received vitamin A supplements capsules (200 000 IU)	Drug: vitamin A supplements gelatinous and reddish opaque capsules containing 200 000 IU vitamin A Other Name: Group B

Detailed Description:

Children from Sekolah Kebangsaan Betau in Pos Betau, Kuala Lipis, Pahang served as the target population for this study.

The selection criteria for study subjects were the following:

Age 7-12 years (according to birth date in birth certificate).
Non-menstruating females (age <13)
No history or evidence of underlying haematological-related diseases such as thalassaemia and ovalocytosis.
No evidence of concomitant severe and/or chronic illness such as acute respiratory tract infections, mental retardation and neurological deficits.
Consent of parent to participate in the study.

Eligibility

Ages Eligible for Study:	7 Years to 12 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Age 7-12 years (according to birth date in birth certificate).
No evidence of concomitant severe and/or chronic illness such as acute respiratory tract infections, mental retardation and neurological deficits.
Consent of parent to participate in the study.

Exclusion Criteria:

history or evidence of underlying haematological-related diseases such as thalassaemia and ovalocytosis.
menstruating females (age >13)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00936091

Locations

Malaysia
National school of Pos Betau
Kuala Lipis, Pahang, Malaysia

Sponsors and Collaborators

Sana'a University

University of Malaya

Ministry of Health, Malaysia

Investigators

Principal Investigator:

Hesham M Al-Mekhlafi, PhD

University of Malaya

More Information

Publications:

Donnen P, Brasseur D, Dramaix M, Vertongen F, Zihindula M, Muhamiriza M, Hennart P. Vitamin A supplementation but not deworming improves growth of malnourished preschool children in eastern Zaire. J Nutr. 1998 Aug;128(8):1320-7.

Hadi H, Stoltzfus RJ, Dibley MJ, Moulton LH, West KP Jr, Kjolhede CL, Sadjimin T. Vitamin A supplementation selectively improves the linear growth of indonesian preschool children: results from a randomized controlled trial. Am J Clin Nutr. 2000 Feb;71(2):507-13.

Payne LG, Koski KG, Ortega-Barria E, Scott ME. Benefit of vitamin A supplementation on ascaris reinfection is less evident in stunted children. J Nutr. 2007 Jun;137(6):1455-9.

Tanumihardjo SA, Permaesih D, Muhilal. Vitamin A status and hemoglobin concentrations are improved in Indonesian children with vitamin A and deworming interventions. Eur J Clin Nutr. 2004 Sep;58(9):1223-30.

Responsible Party:	Prof. Dr. Johari Surin, University of Malaya
ClinicalTrials.gov Identifier:	NCT00936091 History of Changes
Other Study ID Numbers:	PS178-2007B, PS178-2007B
Study First Received:	July 3, 2009
Last Updated:	August 3, 2009
Health Authority:	Malaysia: Ministry of Health

Keywords provided by Sana'a University:

intestinal parasitic infections
malnutrition
Anemia

Additional relevant MeSH terms:

Anemia
Intestinal Diseases, Parasitic
Parasitic Diseases
Malnutrition
Hematologic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Nutrition Disorders
Vitamin A
Vitamins

Retinol palmitate
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012