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
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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 |
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 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 |
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
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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
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- intestinal parasitic infections [ Time Frame: 6 months ]
- growth , iron status & educational achievement [ Time Frame: 6 months ]

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Ages Eligible for Study: | 7 Years to 12 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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)

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
Malaysia | |
National school of Pos Betau | |
Kuala Lipis, Pahang, Malaysia |
Principal Investigator: | Hesham M Al-Mekhlafi, PhD | University of Malaya |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |