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

July 3, 2009
August 3, 2009
May 2007
August 2008   (final data collection date for primary outcome measure)
intestinal parasitic infections [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00936091 on ClinicalTrials.gov Archive Site
growth , iron status & educational achievement [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effects of Vitamin A Supplementation on Intestinal Parasitic Reinfections
Effects of Vitamin A Supplementation on Intestinal Parasitic Reinfections, Growth, Iron Status and Educational Achievement Among Orang Asli Schoolchildren in Pos Betau, Pahang, Malaysia

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.

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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
  • Intestinal Parasitic Infections
  • Malnutrition
  • Anemia
  • Drug: vitamin A supplements
    gelatinous and reddish opaque capsules containing 200 000 IU vitamin A
    Other Name: Group B
  • Drug: Placebo
    125 children received placebo capsules
    Other Name: Group A
  • Placebo Comparator: placebo
    125 schoolchildren were allocated randomly to receive placebo
    Intervention: Drug: Placebo
  • Active Comparator: vitamin A supplement
    125 children received vitamin A supplements capsules (200 000 IU)
    Intervention: Drug: vitamin A supplements

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
250
August 2008
August 2008   (final data collection date for primary outcome measure)

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)
Both
7 Years to 12 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Malaysia
 
NCT00936091
PS178-2007B, PS178-2007B
No
Prof. Dr. Johari Surin, University of Malaya
Sana'a University
  • University of Malaya
  • Ministry of Health, Malaysia
Principal Investigator: Hesham M Al-Mekhlafi, PhD University of Malaya
Sana'a University
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP