Effects of Vitamin A Supplementation on Intestinal Parasitic Reinfections

Sana'a University

Status: Completed

Conditions: Anemia; Malnutrition; Intestinal Parasitic Infections

Treatments: Drug: vitamin A supplements; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00936091

PS178-2007B, PS178-2007B

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 patients

Sex: All

Ages: 7 to 12 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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250 participants in 2 patient groups, including a placebo group

placebo

Placebo Comparator group

Description:

125 schoolchildren were allocated randomly to receive placebo

Treatment:

Drug: Placebo

vitamin A supplement

Active Comparator group

Description:

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

Treatment:

Drug: vitamin A supplements