Anemia Clinical Trial
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
Verified date | July 2009 |
Source | Sana'a University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Malaysia: Ministry of Health |
Study type | Interventional |
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
1. 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.
2. Vitamin A supplementation has a positive effect on growth (weight and height) among
Orang Asli schoolchildren.
3. Vitamin A supplementation is effective in improving serum iron status among Orang Asli
schoolchildren.
4. Vitamin A supplementation has a positive effect on cognitive function and educational
achievement among Orang Asli schoolchildren.
Status | Completed |
Enrollment | 250 |
Est. completion date | August 2008 |
Est. primary completion date | August 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 7 Years to 12 Years |
Eligibility |
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) |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Malaysia | National school of Pos Betau | Kuala Lipis | Pahang |
Lead Sponsor | Collaborator |
---|---|
Sana'a University | Ministry of Health, Malaysia, University of Malaya |
Malaysia,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | intestinal parasitic infections | 6 months | No | |
Secondary | growth , iron status & educational achievement | 6 months | No |
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