Anemia Clinical Trial - Effects of Vitamin A Supplementation on Intestinal

Status Completed

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.

Clinical Trial 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00936091
Study type	Interventional
Source	Sana'a University
Contact
Status	Completed
Phase	N/A
Start date	May 2007
Completion date	August 2008

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Effects of Vitamin A Supplementation on Intestinal Parasitic Reinfections

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms