Vitamin D DeficiencyNCT01432678
Vitamin D Status in Pediatric Asthma
An observational study of Vitamin D Deficiency, run by Mahidol University at 1 site in Thailand.
Trial summary
The purpose of this study is to evaluate level of vitamin D in pediatric asthma and relationship between vitamin D and level control of asthma. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- How many people
- 120 participants
- Where
- 1 siteThailand
- Study dates
- Apr 2011to Jun 2013
- Phase
- Observational
- 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 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: allergy clinic in tertiary hospital
Who may be able to join
- children between the age of 6 years and 18 years with the diagnosis of asthma who are attending the outpatient pediatric department, pediatric allergy clinic
Who cannot join
- patients who have chronic pulmonary, heart disease, chronic renal failure, liver disease, endrocrine disorder, or receieve antiepileptic drugs, vitamin D supplement
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Division of Allergy and Immunology, Department of Pediatrics, Faculty of medicine Siriraj Hospital, Mahidol University
Bangkok, Bangkok
About this study
The purpose of this study is to evaluate level of vitamin D in pediatric asthma and relationship between vitamin D and level control of asthma.
Read the detailed description
cross-sectional study
- Conditions
- Vitamin D Deficiency
- Keywords
- vitamin D, asthma
- Medical subject headings
- Vitamin D Deficiency, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| asthma patients | controlled asthma partly controlled asthma uncontrolled asthma |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2011 (estimated)
- Study startApr 2011
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Orathai Piboonpocanun, Mahidol University
- Investigators
- Orathai Piboonpocanun, Principal investigator, Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01432678
- Sponsor's protocol ID
- 744/2553(EC1)
- Status last verified
- Sep 2014
- First submitted
- 10 Sep 2011
- Last updated
- 9 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Krobtrakulchai W, Praikanahok J, Visitsunthorn N, Vichyanond P, Manonukul K, Pratumvinit B, Jirapongsananuruk O. The effect of vitamin d status on pediatric asthma at a university hospital, Thailand. Allergy Asthma Immunol Res. 2013 Sep;5(5):289-94. doi: 10.4168/aair.2013.5.5.289. Epub 2013 Aug 12.
PubMed 24003385
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Status in Pediatric Asthma
- ClinicalTrials.gov ID
- NCT01432678
- Acronym / sponsor ID
- 744/2553(EC1)
- Conditions
- Vitamin D Deficiency
- Keywords
- vitamin D, asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 13 Sep 2011 (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.
The purpose of this study is to evaluate level of vitamin D in pediatric asthma and relationship between vitamin D and level control of asthma.
Detailed description
cross-sectional study
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| asthma patients | – | –controlled asthma partly controlled asthma uncontrolled asthma |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- allergy clinic in tertiary hospital
Key inclusion criteria (1 listed)
- children between the age of 6 years and 18 years with the diagnosis of asthma who are attending the outpatient pediatric department, pediatric allergy clinic
Key exclusion criteria (1 listed)
- patients who have chronic pulmonary, heart disease, chronic renal failure, liver disease, endrocrine disorder, or receieve antiepileptic drugs, vitamin D supplement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 9 Sep 2014.
- Results publication: PubMed 24003385Krobtrakulchai W, Praikanahok J, Visitsunthorn N, Vichyanond P, Manonukul K, Pratumvinit B, Jirapongsananuruk O. The effect of vitamin d status on pediatric asthma at a university hospital, Thailand. Allergy Asthma Immunol Res. 2013 Sep;5(5):289-94. doi: 10.4168/aair.2013.5.5.289. Epub 2013 Aug 12.
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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.
Orathai Piboonpocanun principal investigator
Siriraj Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vitamin D Deficiency, run by Mahidol University at 1 site in Thailand.
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 1 inclusion and 1 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 9 Sep 2014. 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 Thailand. 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. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01432678, which also lists 1 linked publication.
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 9 Sep 2014.