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| ID | Type | Description | Link |
|---|---|---|---|
| CTRI/2007/091/000008 | Registry Identifier | Clinical Trials Registry of India |
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| Name | Class |
|---|---|
| Dalhousie University | OTHER |
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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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Vitamin D in doses of 100,000 IU |
|
| B | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A. 100,000 IU Cholecalciferol per dose of 3.3ml | Drug | 100,000 IU Cholecalciferol in 3.3ml Migliol (Carrier) oil, once every two weeks for 2 Months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to sputum culture conversion | 8 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Patients Culture Positive | 8 Weeks | |
| Performance Status | 8 Weeks | |
| Time To Sputum Smear Conversion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dilip Mathai, MD, FCAMS | Christian Medical College, Vellore, India | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bethesda Hospital | Ambur | Tamil Nadu | 635 802 | India | ||
| Christian Medical College |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25863562 | Derived | Daley P, Jagannathan V, John KR, Sarojini J, Latha A, Vieth R, Suzana S, Jeyaseelan L, Christopher DJ, Smieja M, Mathai D. Adjunctive vitamin D for treatment of active tuberculosis in India: a randomised, double-blind, placebo-controlled trial. Lancet Infect Dis. 2015 May;15(5):528-34. doi: 10.1016/S1473-3099(15)70053-8. Epub 2015 Apr 8. |
| Label | URL |
|---|---|
| TB control in India | View source |
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| B. Migliol Oil without Cholecalciferol | Other | 3.3 ml Migliol Oil, every two weeks for two months |
|
| 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 |
| Vellore |
| Tamil Nadu |
| 632004 |
| India |
| ID | Term |
|---|---|
| D014397 | Tuberculosis, Pulmonary |
| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
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