NCT00936091

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 3, 2009

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 9, 2009

Completed
Last Updated

August 4, 2009

Status Verified

July 1, 2009

Enrollment Period

1.3 years

First QC Date

July 3, 2009

Last Update Submit

August 3, 2009

Conditions

Intestinal Parasitic InfectionsMalnutritionAnemia

Keywords

intestinal parasitic infectionsmalnutritionAnemia

Outcome Measures

Primary Outcomes (1)

  • intestinal parasitic infections

    6 months

Secondary Outcomes (1)

  • growth , iron status & educational achievement

    6 months

Study Arms (2)

placebo

PLACEBO COMPARATOR

125 schoolchildren were allocated randomly to receive placebo

Drug: Placebo

vitamin A supplement

ACTIVE COMPARATOR

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

Drug: vitamin A supplements

Interventions

vitamin A supplementsDRUG

gelatinous and reddish opaque capsules containing 200 000 IU vitamin A

Also known as: Group B
vitamin A supplement
PlaceboDRUG

125 children received placebo capsules

Also known as: Group A
placebo

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • history or evidence of underlying haematological-related diseases such as thalassaemia and ovalocytosis.
  • menstruating females (age \>13)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National school of Pos Betau

Kuala Lipis, Pahang, Malaysia

Location

Related Publications (5)

  • 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.

    PMID: 9687551BACKGROUND

  • 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.

    PMID: 10648265BACKGROUND

  • 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.

    PMID: 17513406BACKGROUND

  • 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.

    PMID: 15054437BACKGROUND

  • 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.

    PMID: 25127885DERIVED

MeSH Terms

Conditions

MalnutritionAnemia

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Hesham M Al-Mekhlafi, PhD

    University of Malaya

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 3, 2009

First Posted

July 9, 2009

Study Start

May 1, 2007

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

August 4, 2009

Record last verified: 2009-07

Locations

MY(1)