Clinical trial NCT00936091: Effects of Vitamin A Supplementation on Intestinal Parasitic Reinfections
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intestinal Parasitic Infections
Malnutrition
Anemia
Keywords: intestinal parasitic infections
malnutrition
Anemia
Lead sponsor: Sana'a University
Sponsor class: OTHER
Collaborators: name: University of Malaya
name: Ministry of Health, Malaysia
First posted: 2009-07-09
Enrollment: 250
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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.

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 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)

Primary outcomes:
measure: intestinal parasitic infections
timeFrame: 6 months
Secondary outcomes:
measure: growth , iron status & educational achievement
timeFrame: 6 months
Other outcomes:
Locations:
city: Kuala Lipis
country: Malaysia
facility: National school of Pos Betau
state: Pahang
Study officials:
affiliation: University of Malaya
name: Hesham M Al-Mekhlafi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1093/jn/128.8.1320.
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. doi: 10.1093/ajcn/71.2.507.
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. doi: 10.1093/jn/137.6.1455.
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. doi: 10.1038/sj.ejcn.1601953.
citation: 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.