Effects of Vitamin A Supplementation on Intestinal Parasitic Reinfections

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00936091
• Other study ID #: PS178-2007B, PS178-2007B
• 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

Related Conditions & MeSH terms

• Anemia
• Intestinal Diseases, Parasitic
• Intestinal Parasitic Infections
• Malnutrition
• Parasitic Diseases

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