Tuberculosis Clinical Trial
Official title:
Impact of Vitamin D Supplementation on Host Immunity to Mycobacterium Tuberculosis and Response to Treatment: Building Translational Research Capacity in Nutrition and Infectious Diseases in the Republic of Georgia
Tuberculosis bacterium (TB) is a germ that can infect any part of the human body, especially
the lungs. Vitamin D is a hormone present in humans that regulates blood electrolytes such
as calcium and phosphate. There is new information that links vitamin D to the functioning
of our immune system. The purpose of the study is to find out how vitamin D affects the
immune system of patients with TB. We want to find out if correcting low vitamin D levels,
in addition to getting standard therapy for TB, will help the immune system fight off TB
infection more effectively.
The study will be done at the Georgia National Center for Tuberculosis and Lung Diseases
(NCTBLD) in Tbilisi, Republic of Georgia. 220 patients with tuberculosis and 80 family
members or household contacts of patients with tuberculosis will be participating in this
study. TB patients, already receiving standard TB therapy, will be randomly assigned to
either receive the Vitamin D pill or a placebo for a total of sixteen weeks. Neither the
subject nor the investigator will know whether the subject has received the Vitamin D or the
inactive placebo.The subject will orally consume the Vitamin D/placebo tablet 3 times a week
for the 1st 8 weeks (while in hospital) and then once every other week for the last 8 weeks(
during out-patient visits to the hospital).
The main study hypothesis is that Vitamin D supplementation helps patients with
tuberculosis, who are on standard anti TB antibiotic therapy, get better faster.
Status | Completed |
Enrollment | 199 |
Est. completion date | July 2014 |
Est. primary completion date | September 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Patient is age > 18 years; 2. Patient has documented new case of smear-positive pulmonary TB; 3. Patient has received = 1 week of anti-TB therapy; 4. The patient will receive anti-TB therapy in Tbilisi; 5. Patient has provided informed consent. Exclusion Criteria: 1. Patient has had > 30 days of lifetime TB therapy; 2. Patient is currently pregnant or lactating; 3. Patient has a history of organ transplant; 4. Patient has a history of cancer in past 5 years (ineligibility criteria does not include non-melanoma skin cancer); 5. Patient has a history of seizures; 6. Patient has a history of hypercalcemia; 7. Patient has a history of hyperparathyroidism; 8. Patient has a history of sarcoidosis; 9. Patient has a history of nephrolithiasis (renal stones); 10. Patient has taken oral corticosteroids in the past 30 days; 11. Patient is currently using cytotoxic or immunosuppressive drugs; 12. Patient currently has significant renal dysfunction (defined as a serum creatinine of >250mmol/L); 13. Patient requires dialysis therapy; 14. Patient has a history of cirrhosis; 15. Patient is currently incarcerated; 16. Patient is not able to complete all study visits in at the NCTBLD in Tbilisi. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Georgia | National Center for tuberculosis and Lung diseases | Tbilisi |
Lead Sponsor | Collaborator |
---|---|
Emory University |
Georgia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary outcome for this intent-to-treat trial is the time to Mycobacterium tuberculosis sputum culture conversion to negative | Up to 16 weeks from therapy start date | No | |
Secondary | Sputum culture result (positive or negative) | 8 weeks after therapy start date | No |
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