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

NCT00366470 Phase 3 COMPLETED

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).

Details

Lead sponsor	Peter Daley
Phase	Phase 3
Status	COMPLETED
Enrolment	250
Start date	2009-11
Completion	2012-05

Conditions

• Pulmonary Tuberculosis

Interventions

• A. 100,000 IU Cholecalciferol per dose of 3.3ml
• B. Migliol Oil without Cholecalciferol

Primary outcomes

• Time to sputum culture conversion — 8 weeks of treatment

Countries

India