Pulmonary Tuberculosis
Conditions
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. People receiving Vitamin D with anti TB therapy will be compared against people receiving anti TB therapy alone to see if vitamin D contributes to a quicker recovery (as shown by a quicker sputum culture conversion).
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 combination with standard DOTS therapy. It will take place in four South Indian DOTS centres. The required sample size is 250 patients receiving ATT, to be randomised in a 1:1 fashion (125 patients to receive vitamin D and 125 patients to receive placebo).
Interventions
DRUGA. 100,000 IU Cholecalciferol per dose of 3.3ml
100,000 IU Cholecalciferol in 3.3ml Migliol (Carrier) oil, once every two weeks for 2 Months
OTHERB. Migliol Oil without Cholecalciferol
3.3 ml Migliol Oil, every two weeks for two months
Sponsors
Dalhousie University
Peter Daley
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Newly diagnosed smear positive pulmonary tuberculosis. 2. Age between 18 to 75 years 3. No pre-existing liver or renal disease 4. Available for return visits as outlined in the trial protocol 5. 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. Pregnant or lactating women 4. Active diarrhoea, indicating possible fat-soluble vitamin malabsorption. 5. Baseline Hypercalcemia \>10.5 mg/dl
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to sputum culture conversion | 8 weeks of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Performance Status | 8 Weeks |
| Time To Sputum Smear Conversion | Continous |
| Proportion of Patients Smear Positive | 4 Weeks, 8 Weeks, 12 Weeks |
| Percent of Patients Culture Positive | 8 Weeks |
| RNTCP Treatment Outcomes | 24 Weeks |
| Weight Gain | 8 Weeks |
| Time To Growth In Liquid Media | 8 Weeks |
Countries
India
Outcome results
None listed