Effects of Vitamin A Supplementation on Intestinal Parasitic Reinfections

Not Applicable

Completed

• Conditions: Intestinal Parasitic Infections; Malnutrition; Anemia
• Interventions: Drug: Placebo; Drug: vitamin A supplements

• Registration Number: NCT00936091
• Lead Sponsor: Sana'a University

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.

Study Timeline

• Study Start: 2007-05
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Status Verified: 2009-07
• Study First Submitted: 2009-07-03
• Study First Submitted QC: 2009-07-08
• Study First Posted: 2009-07-09
• Last Update Submitted: 2009-08-03
• Last Update Posted: 2009-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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.

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Exclusion Criteria

• history or evidence of underlying haematological-related diseases such as thalassaemia and ovalocytosis.
• menstruating females (age >13)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Placebo	125 schoolchildren were allocated randomly to receive placebo
vitamin A supplement	vitamin A supplements	125 children received vitamin A supplements capsules (200 000 IU)

Primary Outcome Measures

Name	Time	Method
intestinal parasitic infections	6 months

Secondary Outcome Measures

Name	Time	Method
growth , iron status & educational achievement	6 months

Trial Locations

Locations (1)

National school of Pos Betau; 🇲🇾 Kuala Lipis, Pahang, Malaysia