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Effects of Vitamin A Supplementation on Intestinal Parasitic Reinfections

Primary Purpose

Intestinal Parasitic Infections, Malnutrition, Anemia

Status
Completed
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
vitamin A supplements
Placebo
Sponsored by
Sana'a University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Intestinal Parasitic Infections focused on measuring intestinal parasitic infections, malnutrition, Anemia

Eligibility Criteria

7 Years - 12 Years (Child)All SexesAccepts 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)

Sites / Locations

  • National school of Pos Betau

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

placebo

vitamin A supplement

Arm Description

125 schoolchildren were allocated randomly to receive placebo

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

Outcomes

Primary Outcome Measures

intestinal parasitic infections

Secondary Outcome Measures

growth , iron status & educational achievement

Full Information

First Posted
July 3, 2009
Last Updated
August 3, 2009
Sponsor
Sana'a University
Collaborators
University of Malaya, Ministry of Health, Malaysia
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1. Study Identification

Unique Protocol Identification Number
NCT00936091
Brief Title
Effects of Vitamin A Supplementation on Intestinal Parasitic Reinfections
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 Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sana'a University
Collaborators
University of Malaya, Ministry of Health, Malaysia

4. Oversight

Data Monitoring Committee
No

5. 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 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. Vitamin A supplementation has a positive effect on growth (weight and height) among Orang Asli schoolchildren. Vitamin A supplementation is effective in improving serum iron status among Orang Asli schoolchildren. Vitamin A supplementation has a positive effect on cognitive function and educational achievement among Orang Asli schoolchildren.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intestinal Parasitic Infections, Malnutrition, Anemia
Keywords
intestinal parasitic infections, malnutrition, Anemia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
250 (Actual)

8. Arms, Groups, and Interventions

Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
125 schoolchildren were allocated randomly to receive placebo
Arm Title
vitamin A supplement
Arm Type
Active Comparator
Arm Description
125 children received vitamin A supplements capsules (200 000 IU)
Intervention Type
Drug
Intervention Name(s)
vitamin A supplements
Other Intervention Name(s)
Group B
Intervention Description
gelatinous and reddish opaque capsules containing 200 000 IU vitamin A
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Group A
Intervention Description
125 children received placebo capsules
Primary Outcome Measure Information:
Title
intestinal parasitic infections
Time Frame
6 months
Secondary Outcome Measure Information:
Title
growth , iron status & educational achievement
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hesham M Al-Mekhlafi, PhD
Organizational Affiliation
University of Malaya
Official's Role
Principal Investigator
Facility Information:
Facility Name
National school of Pos Betau
City
Kuala Lipis
State/Province
Pahang
Country
Malaysia

12. IPD Sharing Statement

Citations:
PubMed Identifier
9687551
Citation
Donnen P, Brasseur D, Dramaix M, Vertongen F, Zihindula M, Muhamiriza M, Hennart P. Vitamin A supplementation but not deworming improves growth of malnourished preschool children in eastern Zaire. J Nutr. 1998 Aug;128(8):1320-7. doi: 10.1093/jn/128.8.1320.
Results Reference
background
PubMed Identifier
10648265
Citation
Hadi H, Stoltzfus RJ, Dibley MJ, Moulton LH, West KP Jr, Kjolhede CL, Sadjimin T. Vitamin A supplementation selectively improves the linear growth of indonesian preschool children: results from a randomized controlled trial. Am J Clin Nutr. 2000 Feb;71(2):507-13. doi: 10.1093/ajcn/71.2.507.
Results Reference
background
PubMed Identifier
17513406
Citation
Payne LG, Koski KG, Ortega-Barria E, Scott ME. Benefit of vitamin A supplementation on ascaris reinfection is less evident in stunted children. J Nutr. 2007 Jun;137(6):1455-9. doi: 10.1093/jn/137.6.1455.
Results Reference
background
PubMed Identifier
15054437
Citation
Tanumihardjo SA, Permaesih D, Muhilal. Vitamin A status and hemoglobin concentrations are improved in Indonesian children with vitamin A and deworming interventions. Eur J Clin Nutr. 2004 Sep;58(9):1223-30. doi: 10.1038/sj.ejcn.1601953.
Results Reference
background
PubMed Identifier
25127885
Citation
Al-Mekhlafi HM, Anuar TS, Al-Zabedi EM, Al-Maktari MT, Mahdy MA, Ahmed A, Sallam AA, Abdullah WA, Moktar N, Surin J. Does vitamin A supplementation protect schoolchildren from acquiring soil-transmitted helminthiasis? A randomized controlled trial. Parasit Vectors. 2014 Aug 15;7:367. doi: 10.1186/1756-3305-7-367.
Results Reference
derived

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Effects of Vitamin A Supplementation on Intestinal Parasitic Reinfections

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