Effects of Vitamin A Supplementation on Intestinal Parasitic Reinfections

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ClinicalTrials.gov Identifier: NCT00936091

Recruitment Status : Completed

First Posted : July 9, 2009

Last Update Posted : August 4, 2009

Sponsor:

Collaborators:

University of Malaya

Ministry of Health, Malaysia

Information provided by:

Sana'a University

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Intestinal Parasitic Infections Malnutrition Anemia	Drug: vitamin A supplements Drug: Placebo	Not Applicable

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.

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	250 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, 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
Study Start Date :	May 2007
Actual Primary Completion Date :	August 2008
Actual Study Completion Date :	August 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron Malnutrition Parasitic Diseases Vitamin A

Drug Information available for: Retinol Vitamin A palmitate Vitamin A

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

intestinal parasitic infections [ Time Frame: 6 months ]

Secondary Outcome Measures :

growth , iron status & educational achievement [ Time Frame: 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	7 Years to 12 Years (Child)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Al-Mekhlafi HM, Anuar TS, Al-Zabedi EM, Al-Maktari MT, Mahdy MA, Ahmed A, Sallam AA, Abdullah WA, Moktar N, Surin J. Does vitamin A supplementation protect schoolchildren from acquiring soil-transmitted helminthiasis? A randomized controlled trial. Parasit Vectors. 2014 Aug 15;7:367. doi: 10.1186/1756-3305-7-367.


Responsible Party:	Prof. Dr. Johari Surin, University of Malaya
ClinicalTrials.gov Identifier:	NCT00936091 History of Changes
Other Study ID Numbers:	PS178-2007B, PS178-2007B
First Posted:	July 9, 2009 Key Record Dates
Last Update Posted:	August 4, 2009
Last Verified:	July 2009

Keywords provided by Sana'a University:


intestinal parasitic infections malnutrition Anemia

Additional relevant MeSH terms:


Malnutrition Parasitic Diseases Intestinal Diseases, Parasitic Nutrition Disorders Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases Vitamins Vitamin A	Retinol palmitate Micronutrients Growth Substances Physiological Effects of Drugs Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Anticarcinogenic Agents Antineoplastic Agents

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