CTRI/2007/091/000008
Completed
Phase 3
A double blind, randomized, parallel, placebo control design study to determine the effect of addition of Vitamin D to conventional anti TB therapy
Christian Medical College,Vellore0 sites250 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Christian Medical College,Vellore
- Enrollment
- 250
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Newly diagnosed smear positive pulmonary tuberculosis, including previously treated
- •2\.Age between 18 to 75 years
- •3\.No pre\-existing liver or renal disease
- •4\.Consent given for HIV testing
- •5\.Available for return visits as outlined in the trial protocol
- •6\. A firm Home address
Exclusion Criteria
- •1\.Extra\-pulmonary or smear negative tuberculosis
- •2\.Patients receiving steroids, cytotoxic drugs, post transplant or metastatic malignancy, or not expected to survive for the duration of ATT
- •3\.HIV infection
- •4\.Pregnant or lactating women
- •5\. Active diarrhoea, indicating possible fat\-soluble vitamin malabsorption.
- •6\.Baseline Hypercalcemia (\>10\.5 mg/dl)
Outcomes
Primary Outcomes
Not specified
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