Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00366470
Status:
COMPLETED
Last Update Posted:
2012-07-06
First Post:
2006-08-18
Brief Title:
A Clinical Trial to Study the Effect of the Addition of Vitamin D to Conventional Treatment in New Pulmonary Tuberculosis Patients
Sponsor:
Peter Daley
Organization:
Christian Medical College Vellore India
Study Overview
Official Title:
A Double Blind Randomized Parallel Placebo Control Design Study to Determine the Effect of Addition of Vitamin D to Conventional Anti TB Therapy
Status:
COMPLETED
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 11 fashion 125 patients to receive vitamin D and 125 patients to receive placebo
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CTRI2007091000008 | REGISTRY | Clinical Trials Registry of India | None |