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

NCT04342598 | Completed

• 1 other identifier: IRB19-0237
• Study Type: observational
• Target: 352
• Locations: 1 country
• Sites: 1

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; 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

Keywords

Multi-drug resistant tuberculosis; Extensively drug-resistant tuberculosis; Vitamin D; Vitamin D deficiency; Tuberculosis; Latent tuberculosis infection; Diet

Outcome Measures

Primary Outcomes (1)

• Adult pulmonary multi-drug resistant tuberculosis

  Defined by the Guidelines on Programmatic Management of Drug-Resistant TB in India. Includes cases with MDR-TB (resistant to both isoniazid and rifampicin with or without resistance to other first-line drugs), pre-XDR-TB(MDR-TB patients with additional resistance to any/all fluoroquinolones or any/all second-line drugs, or XDR-TB (MDR-TB patients who are additionally resistant to at least one fluoroquinolone and a second-line drug).

  Baseline

Secondary Outcomes (1)

• Latent TB infection among controls

  Baseline

Study Arms (3)

Adult outpatient pulmonary MDR-TB patients

Other: Serum Vitamin D

Household contact controls

Other: Serum Vitamin D

Non-household contact controls

Other: Serum Vitamin D

Interventions

Serum Vitamin D OTHER

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

Also known as: Diet

Adult outpatient pulmonary MDR-TB patients; Household contact controls; Non-household contact controls

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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
• years old
• Permanently living with at least two eligible 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
• years old
• 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
• Pregnancy.

Sponsors & Collaborators

• Harvard School of Public Health (HSPH): lead
• Foundation for Medical Research: collaborator
• Municipal Corporation of Greater Mumbai, India: collaborator

Study Sites (1)

Foundations for Medical Research

Mumbai, Maharashtra, 400 018, India

Location

Related Publications (2)

• Digvijaya, Mittal S, Mittal P, Singh R, Gupta S, Singh T, Khan R, Alzobaidi N, Alhalmi A. Vitamin D Fortification: A Promising Approach to Overcome Drug Resistance and Tolerance in Therapeutic Interventions. Scientifica (Cairo). 2024 Nov 22;2024:9978076. doi: 10.1155/2024/9978076. eCollection 2024.

  PMID: 39618688 DERIVED

• Mistry N, Hemler EC, Dholakia Y, Bromage S, Shukla A, Dev P, Govekar L, Tipre P, Shah D, Keshavjee SA, Fawzi WW. Protocol for a case-control study of vitamin D status, adult multidrug-resistant tuberculosis disease and tuberculosis infection in Mumbai, India. BMJ Open. 2020 Nov 12;10(11):e039935. doi: 10.1136/bmjopen-2020-039935.

  PMID: 33184081 DERIVED

MeSH Terms

Conditions

Tuberculosis, Multidrug-Resistant; Extensively Drug-Resistant Tuberculosis; Vitamin D Deficiency; Tuberculosis; Latent Tuberculosis

Interventions

Diet

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Latent Infection

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Wafaie W Fawzi, MBBS, MPH, MS, DrPH

  Harvard School of Public Health (HSPH)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Nutrition, Epidemiology, and Global Health

Study Record Dates

• First Submitted: April 7, 2020
• First Posted: April 13, 2020
• Study Start: January 27, 2020
• Primary Completion: December 17, 2020
• Study Completion: December 17, 2020
• Last Updated: February 25, 2021

Record last verified: 2021-02

Locations

IN (1)