A clinical trial to study the effect of the addition of Vitamin D to conventional treatment in new pulmonary tuberculosis patients
Phase 3
Completed
- Registration Number
- CTRI/2007/091/000008
- Lead Sponsor
- Christian Medical College,Vellore
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 250
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to sputum culture conversionTimepoint: 8 weeks
- Secondary Outcome Measures
Name Time Method Performance statusTimepoint: 8 weeks;Proportion of patients culture positiveTimepoint: 8 weeks;proportion of patients smear positiveTimepoint: 4 weeks, 8 weeks, 12 weeks;RNTCP treatment outcomesTimepoint: 24 weeks;TIme to growth in liquid mediaTimepoint: 8 weeks;TIme to sputum smear conversionTimepoint: continuous;Weight gainTimepoint: 8 weeks