Effects of Vitamin A Supplementation on Intestinal Parasitic Reinfections

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effects of Vitamin A Supplementation on Intestinal Parasitic Reinfections, Growth, Iron Status and Educational Achievement Among Orang Asli Schoolchildren in Pos Betau, Pahang, Malaysia

Conditions
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Intestinal Parasitic Infections, Malnutrition, Anemia

Intervention / Treatment
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* Drug: vitamin A supplements
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br>125 schoolchildren were allocated randomly to receive placebo | Drug: Placebo<br>* 125 children received placebo capsules<br>* Other names: Group A;|
| Active Comparator: vitamin A supplement<br>125 children received vitamin A supplements capsules (200 000 IU) | Drug: vitamin A supplements<br>* gelatinous and reddish opaque capsules containing 200 000 IU vitamin A<br>* Other names: Group B;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intestinal parasitic infections |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| growth , iron status & educational achievement |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intestinal parasitic infections, malnutrition, Anemia