Effects of Vitamin A Supplementation on Intestinal Parasitic Reinfections

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2008-08-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Intestinal Parasitic Infections Malnutrition Anemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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placebo

125 schoolchildren were allocated randomly to receive placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

125 children received placebo capsules

vitamin A supplement

125 children received vitamin A supplements capsules (200 000 IU)

Group Type ACTIVE_COMPARATOR

vitamin A supplements

Intervention Type DRUG

gelatinous and reddish opaque capsules containing 200 000 IU vitamin A

Interventions

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vitamin A supplements

gelatinous and reddish opaque capsules containing 200 000 IU vitamin A

Intervention Type DRUG

Placebo

125 children received placebo capsules

Intervention Type DRUG

Other Intervention Names

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Group B Group A

Eligibility Criteria

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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.