Status:
COMPLETED
Case Control Study of Vitamin D Status and Adult Multidrug-resistant Pulmonary Tuberculosis in Maharashtra, India
Lead Sponsor:
Harvard School of Public Health (HSPH)
Collaborating Sponsors:
Foundation for Medical Research
Municipal Corporation of Greater Mumbai, India
Conditions:
Multi-drug Resistant Tuberculosis
Eligibility:
All Genders
18-60 years
Brief Summary
India has the highest incidence of and mortality from multi-drug resistant tuberculosis (MDR-TB) globally. Vitamin D status may be an important determinant of MDR-TB infection and treatment outcomes; ...
Detailed Description
To combat the substantial global burdens of TB and MDR-TB, novel treatment strategies and expanded prevention efforts are critical. Although vitamin D supplementation shows promise in both of these ar...
Eligibility Criteria
Inclusion
- Inclusion criteria for cases:
- Currently receiving outpatient treatment for MDR-TB according to standard of care (including new cases and those who have been on treatment for no more than one month)
- Residence in Mumbai M/E, M/W or H/E ward for at least six months
- 18-60 years old
- Permanently living with at least two eligible controls
- Confirmation that they have disclosed their TB status to household and will allow inclusion of their household members in the study
- Inclusion criteria for household contact controls:
- Was a permanent member of the index case's household for at least one year prior to the case's DR TB diagnosis
- No symptoms of active TB disease
- Residence in Mumbai M/E, M/W or H/E ward for at least six months
- 18-60 years old
- Inclusion criteria for non-household controls:
- 18 - 60 years of age
- Residence in Mumbai M/E, M/W or H/E ward for at least six months
- No symptoms of active TB disease
- No history of household contact with a TB patient in last 2 years
- Exclusion criterion for both cases and controls:
- • Pregnancy.
Exclusion
Key Trial Info
Start Date :
January 27 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 17 2020
Estimated Enrollment :
352 Patients enrolled
Trial Details
Trial ID
NCT04342598
Start Date
January 27 2020
End Date
December 17 2020
Last Update
February 25 2021
Active Locations (1)
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1
Foundations for Medical Research
Mumbai, Maharashtra, India, 400 018