Status:
COMPLETED
TB Nutrition, Immunology and Epidemiology
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Mycobacterium Tuberculosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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 f...
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...
Eligibility Criteria
Inclusion
- Men and women, age 18 to 65 years inclusive
- At least two positive sputum smears for tuberculosis (TB)
- Intention to stay in Dar-es-Salaam for at least 2 years after the start of TB therapy
- Subjects who grant informed consent to participation
- Subject is assigned to a treatment clinic where International Collarborations in Infectious Disease Research (ICIDR) staff can follow that patient, either at that clinic directly, or through referral to a nearby clinic for research visits.
Exclusion
- Karnofsky score \< 40%
- Hemoglobin \< 8.5 g/dl
- Having had treatment for TB exceeding 4 weeks in the last 5 years
- Pregnant women: Women who are pregnant at the time of enrollment will also be excluded, given that all pregnant women receive folate and iron supplements as part of routine prenatal services. Also, it is not possible to enroll enough pregnant women to examine the effect of the supplements in this subset.
- Patient is mentally incapable of understanding the consent form; patient is a prisoner or in police custody; or patient is deaf/dumb.
Key Trial Info
Start Date :
June 1 2000
Trial Type :
INTERVENTIONAL
End Date :
October 1 2005
Estimated Enrollment :
887 Patients enrolled
Trial Details
Trial ID
NCT00170404
Start Date
June 1 2000
End Date
October 1 2005
Last Update
August 27 2010
Active Locations (1)
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1
Muhimbili University, College of Health Sciences
Dar es Salaam, Tanzania