TuberculosisNCT01137370
The Impact of Vitamin D on Tuberculosis Among Koreans
An observational study of Tuberculosis, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Vitamin D has been regarded to be beneficial to tuberculosis (TB) patients. The aim of this study is to elucidate the role of vitamin D deficiency in development and treatment outcomes among Korean TB patients. Furthermore, the impact of genotypes of vitamin D receptor gene on TB development will also be evaluated. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis
- How many people
- 203 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2010to Apr 2011
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients diagnosed and treated as having a TB in Seoul National University Hospital
Who may be able to join
- older than 19 years
- diagnosed and treated having a tuberculosis
Who cannot join
- positive HIV antibody
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Vitamin D Level and Single Nucleotide Polymorphisms of Vitamin D Receptor Gene on the Development and Treatment Response of Tuberculosis
Vitamin D has been regarded to be beneficial to tuberculosis (TB) patients. The aim of this study is to elucidate the role of vitamin D deficiency in development and treatment outcomes among Korean TB patients. Furthermore, the impact of genotypes of vitamin D receptor gene on TB development will also be evaluated.
- Conditions
- Tuberculosis
- Medical subject headings
- Tuberculosis
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 |
|---|---|---|
| Patients with TB | Not described | |
| People without TB | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Vitamin D Deficiency
Measured: At enrollment
Median 25-OHD Level
Measured: August 2010 to March 2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2010 (estimated)
- Study startJan 2010
- Primary completionMar 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jae-Joon Yim, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01137370
- Sponsor's protocol ID
- H-0911-066-301
- Status last verified
- Jan 2014
- First submitted
- 3 Jun 2010
- Last updated
- 24 Feb 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Vitamin D Level and Single Nucleotide Polymorphisms of Vitamin D Receptor Gene on the Development and Treatment Response of Tuberculosis
- ClinicalTrials.gov ID
- NCT01137370
- Acronym / sponsor ID
- H-0911-066-301
- Conditions
- Tuberculosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 4 Jun 2010 (estimated)
- Results
- Posted 24 Feb 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Vitamin D has been regarded to be beneficial to tuberculosis (TB) patients. The aim of this study is to elucidate the role of vitamin D deficiency in development and treatment outcomes among Korean TB patients. Furthermore, the impact of genotypes of vitamin D receptor gene on TB development will also be evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with TB | – | – |
| People without TB | – | – |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed and treated as having a TB in Seoul National University Hospital
Key inclusion criteria (2 listed)
- older than 19 years
- diagnosed and treated having a tuberculosis
Key exclusion criteria (1 listed)
- positive HIV antibody
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
Prevalence of Vitamin D Deficiency
Time frame: At enrollment
Median 25-OHD Level
Time frame: August 2010 to March 2011
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Tuberculosis, run by Seoul National University Hospital at 1 site in South Korea.
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 2 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 24 Feb 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 South Korea. 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?
Yes. Results are posted in the registry (first posted 24 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Prevalence of Vitamin D Deficiency (time frame: At enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Feb 2014.