Status:
COMPLETED
A Clinical Trial to Study the Effect of the Addition of Vitamin D to Conventional Treatment in New Pulmonary Tuberculosis Patients
Lead Sponsor:
Peter Daley
Collaborating Sponsors:
Dalhousie University
Conditions:
Pulmonary Tuberculosis
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
There is some evidence that supplemental Vitamin D may contribute to quicker recovery from TB when given in addition to normal TB therapy. This needs to be proven with a controlled clinical trial. Peo...
Detailed Description
The proposed study is a parallel, randomized, double-blinded, placebo-controlled clinical trial to quantify the change, if any, in microbiological outcome in TB patients treated with vitamin D in comb...
Eligibility Criteria
Inclusion
- Newly diagnosed smear positive pulmonary tuberculosis.
- Age between 18 to 75 years
- No pre-existing liver or renal disease
- Available for return visits as outlined in the trial protocol
- A Firm home address
Exclusion
- Extra-pulmonary or smear negative tuberculosis
- Patients receiving steroids, cytotoxic drugs, post transplant or metastatic malignancy, or not expected to survive for the duration of ATT
- Pregnant or lactating women
- Active diarrhoea, indicating possible fat-soluble vitamin malabsorption.
- Baseline Hypercalcemia \>10.5 mg/dl
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT00366470
Start Date
November 1 2009
End Date
May 1 2012
Last Update
July 6 2012
Active Locations (2)
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1
Bethesda Hospital
Ambur, Tamil Nadu, India, 635 802
2
Christian Medical College
Vellore, Tamil Nadu, India, 632004