Effects of Vitamin A Supplementation on Intestinal Parasitic Reinfections

This study has been completed.
Sponsor:
Collaborators:
University of Malaya
Ministry of Health, Malaysia
Information provided by:
Sana'a University
ClinicalTrials.gov Identifier:
NCT00936091
First received: July 3, 2009
Last updated: August 3, 2009
Last verified: July 2009
  Purpose

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.

Condition Intervention
Intestinal Parasitic Infections
Malnutrition
Anemia
Drug: vitamin A supplements
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official 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

Resource links provided by NLM:


Further study details as provided by Sana'a University:

Primary Outcome Measures:
  • intestinal parasitic infections [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • growth , iron status & educational achievement [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 250
Study Start Date: May 2007
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo
125 schoolchildren were allocated randomly to receive placebo
Drug: Placebo
125 children received placebo capsules
Other Name: Group A
Active Comparator: vitamin A supplement
125 children received vitamin A supplements capsules (200 000 IU)
Drug: vitamin A supplements
gelatinous and reddish opaque capsules containing 200 000 IU vitamin A
Other Name: Group B

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.
  Eligibility

Ages Eligible for Study:   7 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00936091

Locations
Malaysia
National school of Pos Betau
Kuala Lipis, Pahang, Malaysia
Sponsors and Collaborators
Sana'a University
University of Malaya
Ministry of Health, Malaysia
Investigators
Principal Investigator: Hesham M Al-Mekhlafi, PhD University of Malaya
  More Information

Publications:
Responsible Party: Prof. Dr. Johari Surin, University of Malaya
ClinicalTrials.gov Identifier: NCT00936091     History of Changes
Other Study ID Numbers: PS178-2007B, PS178-2007B
Study First Received: July 3, 2009
Last Updated: August 3, 2009
Health Authority: Malaysia: Ministry of Health

Keywords provided by Sana'a University:
intestinal parasitic infections
malnutrition
Anemia

Additional relevant MeSH terms:
Anemia
Intestinal Diseases, Parasitic
Parasitic Diseases
Malnutrition
Nutrition Disorders
Hematologic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vitamin A
Vitamins
Retinol palmitate
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 01, 2014