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Completed

NCT Number: NCT00936091

Effects of Vitamin A Supplementation on Intestinal Parasitic Reinfections

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.

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Key information

Conditions

Intestinal Parasitic Infections Anemia Hematologic Diseases Hemic and Lymphatic Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National school of Pos Betau

Kuala Lipis, Pahang, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

vitamin A supplements

Drug

gelatinous and reddish opaque capsules containing 200 000 IU vitamin A

Other names: Group B

Placebo

Drug

125 children received placebo capsules

Other names: Group A

Primary outcomes

  1. intestinal parasitic infections

    Time frame: 6 months

Secondary outcomes

  1. growth , iron status & educational achievement

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Sana'a University

Other

Collaborators

  • Ministry of Health, Malaysia
  • University of Malaya

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jul 9, 2009
Registry last updated
Aug 4, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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