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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Pulmonary Tuberculosis

Intervention / Treatment
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* Drug: A. 100,000 IU Cholecalciferol per dose of 3.3ml
* Other: B. Migliol Oil without Cholecalciferol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Vitamin D in doses of 100,000 IU | Drug: A. 100,000 IU Cholecalciferol per dose of 3.3ml<br>* 100,000 IU Cholecalciferol in 3.3ml Migliol (Carrier) oil, once every two weeks for 2 Months<br>|
| Placebo Comparator: B<br> | Other: B. Migliol Oil without Cholecalciferol<br>* 3.3 ml Migliol Oil, every two weeks for two months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to sputum culture conversion |  | 8 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Patients Culture Positive |  | 8 Weeks | 
| Performance Status |  | 8 Weeks | 
| Time To Sputum Smear Conversion |  | Continous | 
| Proportion of Patients Smear Positive |  | 4 Weeks, 8 Weeks, 12 Weeks | 
| Time To Growth In Liquid Media |  | 8 Weeks | 
| RNTCP Treatment Outcomes |  | 24 Weeks | 
| Weight Gain |  | 8 Weeks |