Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00057434
Status:
COMPLETED
Last Update Posted:
2007-09-18
First Post:
2003-04-01
Brief Title:
Vitamin A Therapy for Tuberculosis
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Adjunct Vitamin A Therapy for Tuberculosis and HIVAIDS
Status:
COMPLETED
Status Verified Date:
2007-08
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:
The study will determine whether a daily vitamin and mineral supplement a multivitamin including Vitamin A will improve health when added to standard chemotherapy for tuberculosis This study will compare the effectiveness of the multivitamin in HIV infected and HIV uninfected patients
Detailed Description:
By the year 2000 138 of individuals with HIV will be co-infected with tuberculosis TB Despite effective TB chemotherapy mortality rates remain extremely high and no simple inexpensive intervention is available Prior to the discovery of antibiotic treatment cod-liver oil a potent source of Vitamin A was the standard treatment for TB Vitamin A is essential for normal immune function and Vitamin A supplementation is used in many countries to reduce mortality in children Vitamin A deficiency in HIV infected people has been associated with increased mortality in the United States Haiti Malawi and Uganda This study will determine whether daily Vitamin A supplementation given concurrently with TB chemotherapy will reduce mortality in adults with HIV and TB
All study participants will receive standard TB chemotherapy isoniazid rifampicin streptomycin pyrazinamide for the first 2 months followed by isoniazid and ethambutol for the following 6 months Participants will be randomized to receive either a daily vitamin and mineral supplement or placebo Participants will be followed for 24 months after study enrollment
All study participants will receive standard TB chemotherapy isoniazid rifampicin streptomycin pyrazinamide for the first 2 months followed by isoniazid and ethambutol for the following 6 months Participants will be randomized to receive either a daily vitamin and mineral supplement or placebo Participants will be followed for 24 months after study enrollment
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