Trial Outcomes & Findings for The Impact of Vitamin D on Tuberculosis Among Koreans (NCT NCT01137370)

NCT ID: NCT01137370

Last Updated: 2014-02-24

Results Overview

• Recruitment status: COMPLETED
• Target enrollment: 203 participants
• Primary outcome timeframe: At enrollment
• Results posted on: 2014-02-24

Participant Flow

from April 2010 to March 2011, at Seoul National University Hospital, a tertiary referral hospital in Seoul, South Korea

Korean who had been abroad for longer than 1 month during the previous year and non-Koreans were excluded from both arms.

Participant milestones

Measure	Patients With TB	People Without TB
Overall Study STARTED	116	87
Overall Study COMPLETED	116	87
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Impact of Vitamin D on Tuberculosis Among Koreans

Baseline characteristics by cohort

Measure	Patients With TB n=116 Participants	People Without TB n=87 Participants	Total n=203 Participants Total of all reporting groups
Age, Categorical <=18 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	78 Participants n=5 Participants	69 Participants n=7 Participants	147 Participants n=5 Participants
Age, Categorical >=65 years	37 Participants n=5 Participants	17 Participants n=7 Participants	54 Participants n=5 Participants
Age, Continuous	52.2 years STANDARD_DEVIATION 18.20 • n=5 Participants	50.9 years STANDARD_DEVIATION 15.20 • n=7 Participants	51.7 years STANDARD_DEVIATION 16.96 • n=5 Participants
Sex: Female, Male Female	52 Participants n=5 Participants	49 Participants n=7 Participants	101 Participants n=5 Participants
Sex: Female, Male Male	64 Participants n=5 Participants	38 Participants n=7 Participants	102 Participants n=5 Participants
Region of Enrollment Korea, Republic of	116 participants n=5 Participants	87 participants n=7 Participants	203 participants n=5 Participants

PRIMARY outcome

Timeframe: At enrollment

Outcome measures

Measure	Patients With TB n=116 Participants	People Without TB n=87 Participants
Prevalence of Vitamin D Deficiency	36.2 participants, %	27.3 participants, %

PRIMARY outcome

Timeframe: August 2010 to March 2011

Outcome measures

Outcome data not reported

Adverse Events

Patients With TB

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

People Without TB

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jae-Joon Yim

Department of Medicine and Lung Institute, Seoul National University College of Medicine

Phone: +82-2-2072-2059

Email: yimjj@snu.ac.kr

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place