Case Control Study of Vitamin D Status and Adult Multidrug-resistant Pulmonary Tuberculosis in Maharashtra, India
Condition: Multi-drug Resistant Tuberculosis
MeSH terms: Tuberculosis; Tuberculosis, Pulmonary; Tuberculosis, Multidrug-Resistant
Study type: Observational

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.
    

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 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.
    

Intervention name(s): Serum Vitamin D
Intervention type(s): Other
Intervention description(s): Primary exposure assessed will be serum vitamin D (25(OH)D). Diet will also be assessed via Food Frequency Questionnaire.
Other intervention name(s): Diet
Intervention MeSH terms: Vitamin D
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Adult pulmonary outpatient MDR-TB cases, household contact controls and non-household
        controls residing in Mumbai in Maharashtra state, India
      
Keywords: Multi-drug resistant tuberculosis; Extensively drug-resistant tuberculosis; Vitamin D; Vitamin D deficiency; Tuberculosis; Latent tuberculosis infection; Diet