Status:
COMPLETED
Impact of Vitamin D Supplementation on Host Immunity to Mycobacterium Tuberculosis and Response to Treatment
Lead Sponsor:
Emory University
Conditions:
Tuberculosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 p...
Detailed Description
This is a double-blind, randomized, controlled clinical trial on the clinical efficacy and antimicrobial mechanisms of oral high dose vitamin D3 therapy three times weekly given for 8 weeks followed b...
Eligibility Criteria
Inclusion
- Patient is age \> 18 years;
- Patient has documented new case of smear-positive pulmonary TB;
- Patient has received ≤ 1 week of anti-TB therapy;
- The patient will receive anti-TB therapy in Tbilisi;
- Patient has provided informed consent.
Exclusion
- Patient has had \> 30 days of lifetime TB therapy;
- Patient is currently pregnant or lactating;
- Patient has a history of organ transplant;
- Patient has a history of cancer in past 5 years (ineligibility criteria does not include non-melanoma skin cancer);
- Patient has a history of seizures;
- Patient has a history of hypercalcemia;
- Patient has a history of hyperparathyroidism;
- Patient has a history of sarcoidosis;
- Patient has a history of nephrolithiasis (renal stones);
- Patient has taken oral corticosteroids in the past 30 days;
- Patient is currently using cytotoxic or immunosuppressive drugs;
- Patient currently has significant renal dysfunction (defined as a serum creatinine of \>250mmol/L);
- Patient requires dialysis therapy;
- Patient has a history of cirrhosis;
- Patient is currently incarcerated;
- Patient is not able to complete all study visits in at the NCTBLD in Tbilisi.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
199 Patients enrolled
Trial Details
Trial ID
NCT00918086
Start Date
July 1 2009
End Date
July 1 2014
Last Update
July 11 2014
Active Locations (1)
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1
National Center for tuberculosis and Lung diseases
Tbilisi, Georgia, 0101