A Clinical Trial to Study the Effect of the Addition of Vitamin D to Conventional Treatment in New Pulmonary Tuberculosis Patients

A Double Blind, Randomized, Parallel, Placebo Control Design Study to Determine the Effect of Addition of Vitamin D to Conventional Anti TB Therapy

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).

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).

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