case control study of vitamin d status and adult multidrug-resistant pulmonary tuberculosis in maharashtra, india

Conditions: Multi-drug Resistant Tuberculosis

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.

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 areas, additional observational evidence is needed to support future randomized clinical trials. this case-control study in mumbai, india will clarify associations between vitamin d status, active mdr-tb disease and tb infection to expand the evidence-base and inform the design of future trials of vitamin d supplementation for use in mdr-tb infection. this study will assess vitamin d status, diet, and anthropometry among adult outpatient mdr-tb cases and controls in mumbai, india and assess tb infection among controls. the specific aims are: 1) evaluate the association between vitamin d status and active mdr-tb infection; 2) evaluate the association between vitamin d status and tb infection among controls; 3) collect formative data to inform the design of future randomized clinical trials evaluating vitamin d supplementation and other interventions in mdr-tb treatment and prevention. to fulfill the first aim, a case-control study will be conducted comparing vitamin d status between pulmonary mdr-tb cases (including extensively drug-resistant (xdr) and pre-xdr cases) and two sets of controls: 1) household controls (recruited from the cases' household contacts) and 2) non-household controls (recruited from non-respiratory departments of local hospitals). the second aim will involve a cross-sectional study among controls assessing the association between vitamin d status and tb infection using quantiferon-tb (qft-tb) interferon-gamma release assays.

Eligibility criteria:
1. 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 2. 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 3. 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.

Keywords: multi-drug resistant tuberculosis extensively drug-resistant tuberculosis vitamin d vitamin d deficiency tuberculosis latent tuberculosis infection diet