Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00170404
Status:
COMPLETED
Last Update Posted:
2010-08-27
First Post:
2005-09-09
Brief Title:
TB Nutrition Immunology and Epidemiology
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Nutrition Immunology and Epidemiology of Tuberculosis
Status:
COMPLETED
Status Verified Date:
2007-02
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 purpose of this study is to see whether people who take vitamins along with the standard medicine for tuberculosis TB recover better and quicker than people who take only the standard medicine for TB This study will enroll 600 men and women who are age 18-65 years have TB and intend to stay in Dar-es-Salaam for at least 2 years from the start of TB therapy Half the participants will have active TB and also HIV infection and the other half will have TB alone Half the volunteers will be given vitamins and the other half will be given placebo sugar pill with no vitamins from the start of their TB therapy through the 8 months of anti-TB therapy and up to 48 months Participation in the study involves visits to the clinic physical exams home visits and answering questions about personal health foods eaten household occupation and education Volunteers will also provide blood sputum and urine samples
Detailed Description:
This double blinded randomized placebo controlled trial will enroll 600 men and women who are age 18 to 65 years inclusive have at least two positive sputum smears for tuberculosis TB intend to stay in Dar-es-Salaam DSM for at least 2 years from the start of TB therapy and have given informed consent to participate in the study Half of the enrollees will have active TB and co-infection with HIV and the other half will have TB alone The effect of micronutrient status will be examined in the context of a randomized trial conducted in Tanzania Subjects will be randomized to receive either multi-micronutrients or placebo from the start of their TB therapy through the 8 months of anti-TB therapy and until the last recruited patient reaches 24 months of follow up Thus the first subject is likely to be followed for 48 months assuming the duration of recruitment is 24 months The endpoints of interest include bacteriologic cure immune response parameters and clinical outcomes The researchers will also examine the utility of these immune response parameters as surrogate markers for treatment efficacy in TB irrespective of nutritional and other risk factors The study will be carried out as a collaborative effort between Harvard School of Public Health Muhimbili University College of Health Sciences Dar es Salaam Tanzania Tufts University Boston and the Channing Laboratory Boston Subjects will be randomly assigned to receive a daily oral dose of one of two treatments a micronutrients 5000 IU of retinol 20 mg of B1 20 mg of B2 25 mg of B6 100 mg of niacin 50 mcg of B12 500 of C 200 mg of E 08 mg of folic acid and 100 mcg of selenium or b placebo The primary objectives are to 1 determine the efficacy of micronutrient supplements on sputum and culture negativity at one month and two months 2 determine the efficacy of micronutrient supplements on survival between two arms at 8 and 24 months and 3 determine the efficacy of micronutrient supplements on TB relapse and reinfection Secondary study objectives are to 1 compare the treatment arms with respect to rate of change of HIV viral load in HIV positive subjects measured at 0 2 8 and 20 months 2 compare the treatment arms with respect to absolute change in CD4 counts from 0 to 2 8 20 months 3 compare the treatment arms with respect to weight change from baseline and 2 months 8 months and 20 months 4 compare the treatment arms with respect to immunological parameters namely ex vivo lymphocyte proliferation and cytokine production namely IL-2 INF-g IL-12 and TNF-a at 2 8 20 months and 5 correlate the above mentioned immunological markers with smear conversion rates at 1 month 2 months cure relapse and death
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