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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00936091
Other study ID # PS178-2007B, PS178-2007B
Secondary ID
Status Completed
Phase N/A
First received July 3, 2009
Last updated August 3, 2009
Start date May 2007
Est. completion date August 2008

Study information

Verified date July 2009
Source Sana'a University
Contact n/a
Is FDA regulated No
Health authority Malaysia: Ministry of Health
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention


Intervention

Drug:
vitamin A supplements
gelatinous and reddish opaque capsules containing 200 000 IU vitamin A
Placebo
125 children received placebo capsules

Locations

Country Name City State
Malaysia National school of Pos Betau Kuala Lipis Pahang

Sponsors (3)

Lead Sponsor Collaborator
Sana'a University Ministry of Health, Malaysia, University of Malaya

Country where clinical trial is conducted

Malaysia, 

References & Publications (4)

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

Outcome

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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