Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:20 PM
Ignite Modification Date:
2025-12-24 @ 9:20 PM
NCT ID:
NCT00170404
Eligibility Criteria:
Inclusion Criteria:
1. Men and women, age 18 to 65 years inclusive
2. At least two positive sputum smears for tuberculosis (TB)
3. Intention to stay in Dar-es-Salaam for at least 2 years after the start of TB therapy
4. Subjects who grant informed consent to participation
5. 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 Criteria:
1. Karnofsky score \< 40%
2. Hemoglobin \< 8.5 g/dl
3. Having had treatment for TB exceeding 4 weeks in the last 5 years
4. 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.
5. Patient is mentally incapable of understanding the consent form; patient is a prisoner or in police custody; or patient is deaf/dumb.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00170404
Study Brief:
Protocol Section:
NCT00170404