TuberculosisNCT01992263
Vitamin D Supplementation and TB
A study testing Vitamin D (600 IU), Vitamin D (2000 IU) and Vitamin D (4000 IU) in people with Tuberculosis and Vitamin D, run by Cornell University at 2 sites in 2 countries.
Trial summary
The goal of this study is to understand the effects of vitamin D supplementation on immunological outcomes among patients with tuberculosis. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Tuberculosis, Vitamin D, Immunity
- What is being tested?
- Vitamin D (600 IU), Vitamin D (2000 IU) and Vitamin D (4000 IU)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jun 2021to Feb 2023
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Active TB diagnosis by GeneXpert
- HIV infection status (according to AMC HIV clinic medical records of enzyme-linked immunosorbent assay [ELISA] results)
Who cannot join
- Children (<18 years of age)
- 60 years of age
- Pregnant at baseline
- Other severe complications or illnesses requiring hospitalization
- Received TB treatment for greater than 4 weeks in the past 5 years
- Refused to participate
- Residing in a geographic location > 1 hour from AMC (by public transit)
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Cornell University
Ithaca, New York, 14853
Elaine Yu, MPH, 714-478-8599, eay27@cornell.edu
Saurabh Mehta, MBBS, ScD
India1 site
Arogyavaram Medical Centre (AMC)
Madanapalle
Wesley Bonam, BSc, MBBS, FAIMS, MRSH, wesleywesleyamc@yahoo.co.in
About this study
Official title: A Trial of Vitamin D Supplementation Among Tuberculosis Patients in South India
The goal of this study is to understand the effects of vitamin D supplementation on immunological outcomes among patients with tuberculosis.
Read the detailed description
In this randomized trial, the investigators will enroll 200 adults with active pulmonary tuberculosis (TB; among whom 40 have HIV co-infections) at the time of TB diagnosis in S India. The intervention will include daily vitamin D supplementation in 3 treatment arms (600, 2000, and 4000 IU vitamin D), compared to placebo, for 12 months. The investigators' primary objectives are to assess how vitamin D supplementation affects immunity (immunological markers, immune competence) and serum vitamin D levels. Secondary outcomes include TB treatment outcomes (successful sputum smear conversion, relapse) in all patients, and human immunodeficiency virus (HIV) disease progression among a subset of patients with HIV co-infection.
- Conditions
- Tuberculosis, Vitamin D, Immunity
- Being tested
- Vitamin D (600 IU), Vitamin D (2000 IU), Vitamin D (4000 IU), Placebo
- Keywords
- tuberculosis, vitamin D, immunity
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D (600 IU)Dietary supplement
Daily oral dose for 12 months
Vitamin D (2000 IU)Dietary supplement
Daily oral dose for 12 months
Vitamin D (4000 IU)Dietary supplement
Daily oral dose for 12 months
PlaceboOther
Daily oral dose for 12 months
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D (600 IU) | Experimental | Not described Receives: Dietary Supplement: Vitamin D (600 IU) |
| Vitamin D (2000 IU) | Experimental | Not described Receives: Dietary Supplement: Vitamin D (2000 IU) |
| Vitamin D (4000 IU) | Experimental | Not described Receives: Dietary Supplement: Vitamin D (4000 IU) |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune function
Immune responses will be assessed by the superoxide bursts and proteolytic capacities of macrophages and monocytes. Activity indexes will be assessed by comparing mean substrate and calibration fluorescence.
Measured: One year
Cell-mediated immunological markers
T cells
Measured: One year
Vitamin D status
Serum 25(OH)D concentrations
Measured: One year
Secondary outcomes (2)
TB treatment outcomes
TB treatment success and relapse
Measured: One year
HIV disease progression
WHO HIV disease stages
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startJun 2021 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Arogyavaram Medical Centre
- Responsible party
- Sponsor
- Investigators
- Saurabh Mehta, MBBS, ScD, Principal investigator, Cornell University (U.S.)Wesley Bonam, BSc, MBBS, FAIMS, MRSH, Principal investigator, Arogyavaram Medical Centre (India)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01992263
- Sponsor's protocol ID
- IRB #: 1304003801
- Status last verified
- Sep 2020
- First submitted
- 1 Nov 2013
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial of Vitamin D Supplementation Among Tuberculosis Patients in South India
- ClinicalTrials.gov ID
- NCT01992263
- Acronym / sponsor ID
- IRB #: 1304003801
- Conditions
- Tuberculosis, Vitamin D, Immunity
- Keywords
- tuberculosis, vitamin D, immunity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Cornell UniversityUniversity, hospital or other
- Collaborators
- Arogyavaram Medical Centre
- Study start
- Jun 2021 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 25 Nov 2013 (estimated)
- 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.
The goal of this study is to understand the effects of vitamin D supplementation on immunological outcomes among patients with tuberculosis.
Detailed description
In this randomized trial, the investigators will enroll 200 adults with active pulmonary tuberculosis (TB; among whom 40 have HIV co-infections) at the time of TB diagnosis in S India. The intervention will include daily vitamin D supplementation in 3 treatment arms (600, 2000, and 4000 IU vitamin D), compared to placebo, for 12 months. The investigators' primary objectives are to assess how vitamin D supplementation affects immunity (immunological markers, immune competence) and serum vitamin D levels. Secondary outcomes include TB treatment outcomes (successful sputum smear conversion, relapse) in all patients, and human immunodeficiency virus (HIV) disease progression among a subset of patients with HIV co-infection.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Vitamin D (600 IU) | Experimental | Dietary Supplement: Vitamin D (600 IU) |
| Vitamin D (2000 IU) | Experimental | Dietary Supplement: Vitamin D (2000 IU) |
| Vitamin D (4000 IU) | Experimental | Dietary Supplement: Vitamin D (4000 IU) |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Active TB diagnosis by GeneXpert
- HIV infection status (according to AMC HIV clinic medical records of enzyme-linked immunosorbent assay [ELISA] results)
Key exclusion criteria (7 listed)
- Children (<18 years of age)
- 60 years of age
- Pregnant at baseline
- Other severe complications or illnesses requiring hospitalization
- Received TB treatment for greater than 4 weeks in the past 5 years
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 |
|---|---|---|
| Vitamin D (600 IU)Daily oral dose for 12 months | Dietary supplement | Vitamin D (600 IU) |
| Vitamin D (2000 IU)Daily oral dose for 12 months | Dietary supplement | Vitamin D (2000 IU) |
| Vitamin D (4000 IU)Daily oral dose for 12 months | Dietary supplement | Vitamin D (4000 IU) |
| PlaceboDaily oral dose for 12 months | Other | Placebo |
Primary outcome
Immune function
Time frame: One year
Immune responses will be assessed by the superoxide bursts and proteolytic capacities of macrophages and monocytes. Activity indexes will be assessed by comparing mean substrate and calibration fluorescence.
Cell-mediated immunological markers
Time frame: One year
T cells
Vitamin D status
Time frame: One year
Serum 25(OH)D concentrations
2 secondary outcomes
TB treatment outcomes
Time frame: One year
HIV disease progression
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
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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.
Saurabh Mehta, MBBS, ScD principal investigator
Cornell University (U.S.)
Wesley Bonam, BSc, MBBS, FAIMS, MRSH principal investigator
Arogyavaram Medical Centre (India)
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D (600 IU), Vitamin D (2000 IU) and Vitamin D (4000 IU) in people with Tuberculosis and Vitamin D, run by Cornell University at 2 sites in 2 countries.
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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Saurabh Mehta, MBBS, ScD (607-255-2640, smehta@cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immune function (time frame: One year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Sep 2020.