Intestinal Parasitic InfectionsNCT00936091
Effects of Vitamin A Supplementation on Intestinal Parasitic Reinfections
A study testing vitamin A supplements in people with Intestinal Parasitic Infections and Malnutrition, run by Sana'a University at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Intestinal Parasitic Infections, Malnutrition, Anemia
- What is being tested?
- vitamin A supplements
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 1 siteMalaysia
- Study dates
- May 2007to Aug 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- history or evidence of underlying haematological-related diseases such as thalassaemia and ovalocytosis.
- menstruating females (age >13)
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Intestinal Parasitic Infections, Malnutrition, Anemia
- Being tested
- vitamin A supplements, Placebo
- Keywords
- intestinal parasitic infections, malnutrition, Anemia
- Medical subject headings
- Malnutrition, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin A supplementsDrug
Also called Group B
gelatinous and reddish opaque capsules containing 200 000 IU vitamin A
PlaceboDrug
Also called Group A
125 children received placebo capsules
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | 125 schoolchildren were allocated randomly to receive placebo Receives: Drug: Placebo |
| vitamin A supplement | Active comparator | 125 children received vitamin A supplements capsules (200 000 IU) Receives: Drug: vitamin A supplements |
What is being measured
The primary outcome is the main question the study is designed to answer.
intestinal parasitic infections
Measured: 6 months
Secondary outcomes (1)
growth , iron status & educational achievement
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2009 (estimated)
- Study startMay 2007
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Intestinal Parasitic InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sana'a University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Malaya, Ministry of Health, Malaysia
- Investigators
- Hesham M Al-Mekhlafi, PhD, Principal investigator, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00936091
- Sponsor's protocol ID
- PS178-2007B, PS178-2007B
- Status last verified
- Jul 2009
- First submitted
- 3 Jul 2009
- Last updated
- 4 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 9687551Hadi 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.
PubMed 10648265Payne 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.
PubMed 17513406Tanumihardjo 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.
PubMed 15054437Al-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.
PubMed 25127885
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00936091
- Acronym / sponsor ID
- PS178-2007B, PS178-2007B
- Conditions
- Intestinal Parasitic Infections, Malnutrition, Anemia
- Keywords
- intestinal parasitic infections, malnutrition, Anemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Sana'a UniversityUniversity, hospital or other
- Collaborators
- University of Malaya, Ministry of Health, Malaysia
- Study start
- May 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 9 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: Placebo125 schoolchildren were allocated randomly to receive placebo |
| vitamin A supplement | Active comparator | Drug: vitamin A supplements125 children received vitamin A supplements capsules (200 000 IU) |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- history or evidence of underlying haematological-related diseases such as thalassaemia and ovalocytosis.
- menstruating females (age >13)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vitamin A supplementsAlso: Group Bgelatinous and reddish opaque capsules containing 200 000 IU vitamin A | Drug | vitamin A supplement |
| PlaceboAlso: Group A125 children received placebo capsules | Drug | placebo |
Primary outcome
intestinal parasitic infections
Time frame: 6 months
1 secondary outcome
growth , iron status & educational achievement
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2009.
- Background: PubMed 9687551Donnen 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.
- Background: PubMed 10648265Hadi 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.
- Background: PubMed 17513406Payne 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.
- Background: PubMed 15054437Tanumihardjo 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.
- Derived from this study: PubMed 25127885Al-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hesham M Al-Mekhlafi, PhD principal investigator
University of Malaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vitamin A supplements in people with Intestinal Parasitic Infections and Malnutrition, run by Sana'a University at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intestinal parasitic infections (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00936091, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2009.