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Case Control Study of Vitamin D Status and Adult Multidrug-resistant Pulmonary Tuberculosis in Maharashtra, India

NCT04342598 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 352

Last updated 2021-02-25

No results posted yet for this study

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; however, observational evidence is insufficient to support its use as an adjunct therapy or prophylaxis. Using a case-control design, this study will evaluate the relationship between vitamin D status and active MDR-TB disease among adult outpatient pulmonary MDR-TB cases, household contact controls, and matched controls from the general population (non-household controls) in Mumbai, India. This study will also evaluate the cross-sectional association between vitamin D status and TB infection among household contact controls and non-household controls, and collect formative data in preparation for future randomized controlled trials of vitamin D in MDR-TB prevention and treatment in India.

Conditions

  • Multi-drug Resistant Tuberculosis

Interventions

OTHER

Serum Vitamin D

Primary exposure assessed will be serum vitamin D (25(OH)D). Diet will also be assessed via Food Frequency Questionnaire.

Sponsors & Collaborators

  • Foundation for Medical Research

    collaborator OTHER

  • Municipal Corporation of Greater Mumbai, India

    collaborator UNKNOWN

  • Harvard School of Public Health (HSPH)

    lead OTHER

Principal Investigators

  • Wafaie W Fawzi, MBBS, MPH, MS, DrPH · Harvard School of Public Health (HSPH)

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-01-27
Primary Completion
2020-12-17
Completion
2020-12-17

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04342598 on ClinicalTrials.gov