NCT01137370

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
203

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

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

January 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 3, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 4, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

February 24, 2014

Completed
Last Updated

February 24, 2014

Status Verified

January 1, 2014

Enrollment Period

1.2 years

First QC Date

June 3, 2010

Results QC Date

January 3, 2014

Last Update Submit

January 3, 2014

Conditions

Tuberculosis

Outcome Measures

Primary Outcomes (2)

  • Prevalence of Vitamin D Deficiency

    At enrollment

  • Median 25-OHD Level

    August 2010 to March 2011

Study Arms (2)

Patients with TB

People without TB

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients diagnosed and treated as having a TB in Seoul National University Hospital

You may qualify if:

  • older than 19 years
  • diagnosed and treated having a tuberculosis

You may not qualify if:

  • positive HIV antibody

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serums for vitamin D measurement DNA for genotyping of vitamin D receptor gene

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Limitations and Caveats

We did not evaluate the participants' dietary intake of vitamin D or their outdoor activities,and DEXA and PTH were not measured which indicate vitamin D insufficiency.

Results Point of Contact

Title
Jae-Joon Yim
Organization
Department of Medicine and Lung Institute, Seoul National University College of Medicine
yimjj@snu.ac.kr
+82-2-2072-2059

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 3, 2010

First Posted

June 4, 2010

Study Start

January 1, 2010

Primary Completion

March 1, 2011

Study Completion

April 1, 2011

Last Updated

February 24, 2014

Results First Posted

February 24, 2014

Record last verified: 2014-01

Locations

KR(1)