Multi-drug Resistant TuberculosisNCT04342598
Case Control Study of Vitamin D Status and Adult Multidrug-resistant Pulmonary Tuberculosis in Maharashtra, India
An observational study of Multi-drug Resistant Tuberculosis, run by Harvard School of Public Health (HSPH) at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Multi-drug Resistant Tuberculosis
- What is being tested?
- Serum Vitamin D
- How many people
- 352 participants
- Where
- 1 siteIndia
- Study dates
- 27 Jan 2020to 17 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Adult pulmonary outpatient MDR-TB cases, household contact controls and non-household controls residing in Mumbai in Maharashtra state, India
Who may be able to join
None listed.
Who cannot join
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Multi-drug Resistant Tuberculosis
- Being tested
- Serum Vitamin D
- Keywords
- Multi-drug resistant tuberculosis, Extensively drug-resistant tuberculosis, Vitamin D, Vitamin D deficiency, Tuberculosis, Latent tuberculosis infection, Diet
- Medical subject headings
- Tuberculosis, Multidrug-Resistant, Extensively Drug-Resistant Tuberculosis, Vitamin D Deficiency, Tuberculosis, Latent Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum Vitamin DOther
Also called Diet
Primary exposure assessed will be serum vitamin D (25(OH)D). Diet will also be assessed via Food Frequency Questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| Adult outpatient pulmonary MDR-TB patients | Not described Receives: Other: Serum Vitamin D | |
| Household contact controls | Not described Receives: Other: Serum Vitamin D | |
| Non-household contact controls | Not described Receives: Other: Serum Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline
Secondary outcomes (1)
Latent TB infection among controls
Assessed using QuantiFERON-TB (QFT-TB) interferon-gamma release assays.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2020
- Study start27 Jan 2020
- Primary completion17 Dec 2020
- Study completion17 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Multi-drug Resistant TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 352 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation for Medical Research, Municipal Corporation of Greater Mumbai, India
- Responsible party
- Principal investigator, Wafaie Fawzi, Harvard School of Public Health (HSPH)
- Investigators
- Wafaie W Fawzi, MBBS, MPH, MS, DrPH, Principal investigator, Harvard School of Public Health (HSPH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04342598
- Sponsor's protocol ID
- IRB19-0237
- Status last verified
- Feb 2021
- First submitted
- 7 Apr 2020
- Last updated
- 25 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 39618688Mistry 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.
PubMed 33184081
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Case Control Study of Vitamin D Status and Adult Multidrug-resistant Pulmonary Tuberculosis in Maharashtra, India
- ClinicalTrials.gov ID
- NCT04342598
- Acronym / sponsor ID
- IRB19-0237
- Conditions
- Multi-drug Resistant Tuberculosis
- Keywords
- Multi-drug resistant tuberculosis, Extensively drug-resistant tuberculosis, Vitamin D, Vitamin D deficiency, Tuberculosis, Latent tuberculosis infection, Diet
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 352 participants (actual)
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Collaborators
- Foundation for Medical Research, Municipal Corporation of Greater Mumbai, India
- Study start
- 27 Jan 2020 (actual)
- Primary completion
- 17 Dec 2020 (actual)
- Study completion
- 17 Dec 2020 (actual)
- First posted
- 13 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Adult pulmonary outpatient MDR-TB cases, household contact controls and non-household controls residing in Mumbai in Maharashtra state, India
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serum Vitamin DAlso: DietPrimary exposure assessed will be serum vitamin D (25(OH)D). Diet will also be assessed via Food Frequency Questionnaire. | Other | Adult outpatient pulmonary MDR-TB patients, Household contact controls, Non-household contact controls |
Primary outcome
Adult pulmonary multi-drug resistant tuberculosis
Time frame: Baseline
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).
1 secondary outcome
Latent TB infection among controls
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2021.
- Derived from this study: PubMed 39618688Digvijaya, 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.
- Derived from this study: PubMed 33184081Mistry 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.
- Individual participant dataSharing planned: Undecided
Related trials for Multi-drug Resistant Tuberculosis
RecruitingPhase 3
Feasibility of the Application of a New Six-month Treatment for Multidrug-resistant Tuberculosis (MDR-TB) Patients in France (FAST-MDR)
MDR-TB, Tuberculosis Multi Drug Resistant Active
Recruiting
An Adaptive Randomized Controlled Trial
Multi Drug Resistant Tuberculosis, HIV Infections
RecruitingPhase 4
Linezolid Tolerance During the BPaL Regimen With Dosage Personalization Based on Therapeutic Drug Monitoring (TDM) During Multidrug-Resistant Tuberculosis Treatment
Linezolid, Tuberculosis Multi Drug Resistant Active
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wafaie W Fawzi, MBBS, MPH, MS, DrPH principal investigator
Harvard School of Public Health (HSPH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multi-drug Resistant Tuberculosis, run by Harvard School of Public Health (HSPH) at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adult pulmonary multi-drug resistant tuberculosis (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04342598, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2021; AzTrials last refreshed its copy on 7 Nov 2026.