Effects of Vitamin A Supplementation on Intestinal Parasi... | NCT00936091

Studies
Effects of Vitamin A Supplementation on Intestinal Parasitic Reinfections

NCT00936091

Sponsor

Sana'a University

Status

Completed

Last Update Posted

Aug 4, 2009Estimated

Enrollment

250Actual

Phase

Not Applicable

Conditions

Intestinal Parasitic Infections
Malnutrition
Anemia

Interventions

vitamin A supplements
Placebo

Countries

Malaysia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2007

Primary Completion Date

Aug 2008Actual

Completion Date

Aug 2008Actual

First Submitted Date

Jul 3, 2009

First Submission Date that Met QC Criteria

Jul 8, 2009

First Posted Date

Jul 9, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 3, 2009

Last Update Posted Date

Aug 4, 2009Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Sana'a UniversityOTHER

Collaborators

Name	Class
University of Malaya	OTHER
Ministry of Health, Malaysia	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

250Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
vitamin A supplements	Drug	gelatinous and reddish opaque capsules containing 200 000 IU vitamin A	vitamin A supplement

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
intestinal parasitic infections		6 months

Secondary Outcomes

Measure	Description	Time Frame
growth , iron status & educational achievement		6 months

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

7 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hesham M Al-Mekhlafi, PhD	University of Malaya	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National school of Pos Betau		Kuala Lipis	Pahang		Malaysia

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
9687551	Background	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.
10648265	Background	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.

ID	Term
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

ID	Term
D044342	Malnutrition
D000740	Anemia