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Effects of Vitamin A Supplementation on Intestinal Parasitic Reinfections

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ClinicalTrials.gov Identifier: NCT00936091
Recruitment Status : Completed
First Posted : July 9, 2009
Last Update Posted : August 4, 2009
Sponsor:
Collaborators:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Intestinal Parasitic Infections Malnutrition Anemia Drug: vitamin A supplements Drug: Placebo

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : May 2007
Primary Completion Date : August 2008
Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. intestinal parasitic infections [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. growth , iron status & educational achievement [ Time Frame: 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Dr. Johari Surin, University of Malaya
ClinicalTrials.gov Identifier: NCT00936091     History of Changes
Other Study ID Numbers: PS178-2007B, PS178-2007B
First Posted: July 9, 2009    Key Record Dates
Last Update Posted: August 4, 2009
Last Verified: July 2009

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

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