Tuberculosis
Conditions
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.
Interventions
None listed
Sponsors
Seoul National University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* older than 19 years * diagnosed and treated having a tuberculosis
Exclusion criteria
* positive HIV antibody
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prevalence of Vitamin D Deficiency | At enrollment |
| Median 25-OHD Level | August 2010 to March 2011 |
Countries
South Korea
Participant flow
Recruitment details
from April 2010 to March 2011, at Seoul National University Hospital, a tertiary referral hospital in Seoul, South Korea
Pre-assignment details
Korean who had been abroad for longer than 1 month during the previous year and non-Koreans were excluded from both arms.
Participants by arm
| Arm | Count |
|---|---|
| Patients With TB | 116 |
| People Without TB | 87 |
| Total | 203 |
Baseline characteristics
| Characteristic | Total | Patients With TB | People Without TB |
|---|---|---|---|
| Age, Categorical <=18 years | 2 Participants | 1 Participants | 1 Participants |
| Age, Categorical >=65 years | 54 Participants | 37 Participants | 17 Participants |
| Age, Categorical Between 18 and 65 years | 147 Participants | 78 Participants | 69 Participants |
| Age, Continuous | 51.7 years STANDARD_DEVIATION 16.96 | 52.2 years STANDARD_DEVIATION 18.2 | 50.9 years STANDARD_DEVIATION 15.2 |
| Region of Enrollment Korea, Republic of | 203 participants | 116 participants | 87 participants |
| Sex: Female, Male Female | 101 Participants | 52 Participants | 49 Participants |
| Sex: Female, Male Male | 102 Participants | 64 Participants | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Median 25-OHD Level
Time frame: August 2010 to March 2011
Primary
Prevalence of Vitamin D Deficiency
Time frame: At enrollment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients With TB | Prevalence of Vitamin D Deficiency | 36.2 participants, % |
| People Without TB | Prevalence of Vitamin D Deficiency | 27.3 participants, % |