Pulmonary TuberculosisPhase 3NCT00366470
A Clinical Trial to Study the Effect of the Addition of Vitamin D to Conventional Treatment in New Pulmonary Tuberculosis Patients
A Phase 3 study testing A. 100,000 IU Cholecalciferol per dose of 3.3ml and B. Migliol Oil without Cholecalciferol in people with Pulmonary Tuberculosis, run by Peter Daley at 2 sites in India.
Trial summary
There is some evidence that supplemental Vitamin D may contribute to quicker recovery from TB when given in addition to normal TB therapy. This needs to be proven with a controlled clinical trial. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pulmonary Tuberculosis
- What is being tested?
- A. 100,000 IU Cholecalciferol per dose of 3.3ml and B. Migliol Oil without Cholecalciferol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 2 sitesIndia
- Study dates
- Nov 2009to May 2012
- Phase
- Phase 3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed smear positive pulmonary tuberculosis.
- Age between 18 to 75 years
- No pre-existing liver or renal disease
- Available for return visits as outlined in the trial protocol
- A Firm home address
Who cannot join
- Extra-pulmonary or smear negative tuberculosis
- Patients receiving steroids, cytotoxic drugs, post transplant or metastatic malignancy, or not expected to survive for the duration of ATT
- Pregnant or lactating women
- Active diarrhoea, indicating possible fat-soluble vitamin malabsorption.
- Baseline Hypercalcemia >10.5 mg/dl
Trial locations and contacts
2 sites in 1 country.
India2 sites
Bethesda Hospital
Ambur, Tamil Nadu, 635 802
Christian Medical College
Vellore, Tamil Nadu, 632004
About this study
Official title: A Double Blind, Randomized, Parallel, Placebo Control Design Study to Determine the Effect of Addition of Vitamin D to Conventional Anti TB Therapy
There is some evidence that supplemental Vitamin D may contribute to quicker recovery from TB when given in addition to normal TB therapy. This needs to be proven with a controlled clinical trial. People receiving Vitamin D with anti TB therapy will be compared against people receiving anti TB therapy alone to see if vitamin D contributes to a quicker recovery (as shown by a quicker sputum culture conversion).
Read the detailed description
The proposed study is a parallel, randomized, double-blinded, placebo-controlled clinical trial to quantify the change, if any, in microbiological outcome in TB patients treated with vitamin D in combination with standard DOTS therapy. It will take place in four South Indian DOTS centres. The required sample size is 250 patients receiving ATT, to be randomised in a 1:1 fashion (125 patients to receive vitamin D and 125 patients to receive placebo).
- Conditions
- Pulmonary Tuberculosis
- Being tested
- A. 100,000 IU Cholecalciferol per dose of 3.3ml, B. Migliol Oil without Cholecalciferol
- Medical subject headings
- Tuberculosis, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A. 100,000 IU Cholecalciferol per dose of 3.3mlDrug
100,000 IU Cholecalciferol in 3.3ml Migliol (Carrier) oil, once every two weeks for 2 Months
B. Migliol Oil without CholecalciferolOther
3.3 ml Migliol Oil, every two weeks for two months
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Vitamin D in doses of 100,000 IU Receives: Drug: A. 100,000 IU Cholecalciferol per dose of 3.3ml |
| B | Placebo comparator | Not described Receives: Other: B. Migliol Oil without Cholecalciferol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to sputum culture conversion
Measured: 8 weeks of treatment
Secondary outcomes (7)
Percent of Patients Culture Positive
Measured: 8 Weeks
Performance Status
Measured: 8 Weeks
Time To Sputum Smear Conversion
Measured: Continous
Proportion of Patients Smear Positive
Measured: 4 Weeks, 8 Weeks, 12 Weeks
Time To Growth In Liquid Media
Measured: 8 Weeks
RNTCP Treatment Outcomes
Measured: 24 Weeks
Weight Gain
Measured: 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2006 (estimated)
- Study startNov 2009
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peter Daley
- Sponsor type
- University, hospital or other
- Collaborators
- Dalhousie University
- Responsible party
- Sponsor-investigator, Peter Daley, Christian Medical College, Vellore, India
- Investigators
- Dilip Mathai, MD, FCAMS, Principal investigator, Christian Medical College, Vellore, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00366470
- Sponsor's protocol ID
- TB-VitaminD
- Other IDs
- CTRI/2007/091/000008
- Status last verified
- Jul 2012
- First submitted
- 18 Aug 2006
- Last updated
- 6 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Daley P, Jagannathan V, John KR, Sarojini J, Latha A, Vieth R, Suzana S, Jeyaseelan L, Christopher DJ, Smieja M, Mathai D. Adjunctive vitamin D for treatment of active tuberculosis in India: a randomised, double-blind, placebo-controlled trial. Lancet Infect Dis. 2015 May;15(5):528-34. doi: 10.1016/S1473-3099(15)70053-8. Epub 2015 Apr 8.
PubMed 25863562
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Randomized, Parallel, Placebo Control Design Study to Determine the Effect of Addition of Vitamin D to Conventional Anti TB Therapy
- ClinicalTrials.gov ID
- NCT00366470
- Acronym / sponsor ID
- TB-VitaminD
- Conditions
- Pulmonary Tuberculosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Peter DaleyUniversity, hospital or other
- Collaborators
- Dalhousie University
- Study start
- Nov 2009
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 21 Aug 2006 (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.
There is some evidence that supplemental Vitamin D may contribute to quicker recovery from TB when given in addition to normal TB therapy. This needs to be proven with a controlled clinical trial. People receiving Vitamin D with anti TB therapy will be compared against people receiving anti TB therapy alone to see if vitamin D contributes to a quicker recovery (as shown by a quicker sputum culture conversion).
Detailed description
The proposed study is a parallel, randomized, double-blinded, placebo-controlled clinical trial to quantify the change, if any, in microbiological outcome in TB patients treated with vitamin D in combination with standard DOTS therapy. It will take place in four South Indian DOTS centres. The required sample size is 250 patients receiving ATT, to be randomised in a 1:1 fashion (125 patients to receive vitamin D and 125 patients to receive placebo).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: A. 100,000 IU Cholecalciferol per dose of 3.3mlVitamin D in doses of 100,000 IU |
| B | Placebo comparator | Other: B. Migliol Oil without Cholecalciferol |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Newly diagnosed smear positive pulmonary tuberculosis.
- Age between 18 to 75 years
- No pre-existing liver or renal disease
- Available for return visits as outlined in the trial protocol
- A Firm home address
Key exclusion criteria (5 listed)
- Extra-pulmonary or smear negative tuberculosis
- Patients receiving steroids, cytotoxic drugs, post transplant or metastatic malignancy, or not expected to survive for the duration of ATT
- Pregnant or lactating women
- Active diarrhoea, indicating possible fat-soluble vitamin malabsorption.
- Baseline Hypercalcemia >10.5 mg/dl
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 |
|---|---|---|
| A. 100,000 IU Cholecalciferol per dose of 3.3ml100,000 IU Cholecalciferol in 3.3ml Migliol (Carrier) oil, once every two weeks for 2 Months | Drug | A |
| B. Migliol Oil without Cholecalciferol3.3 ml Migliol Oil, every two weeks for two months | Other | B |
Primary outcome
Time to sputum culture conversion
Time frame: 8 weeks of treatment
7 secondary outcomes
Percent of Patients Culture Positive
Time frame: 8 Weeks
Performance Status
Time frame: 8 Weeks
Time To Sputum Smear Conversion
Time frame: Continous
Proportion of Patients Smear Positive
Time frame: 4 Weeks, 8 Weeks, 12 Weeks
Time To Growth In Liquid Media
Time frame: 8 Weeks
RNTCP Treatment Outcomes
Time frame: 24 Weeks
Weight Gain
Time frame: 8 Weeks
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 6 Jul 2012.
- Derived from this study: PubMed 25863562Daley P, Jagannathan V, John KR, Sarojini J, Latha A, Vieth R, Suzana S, Jeyaseelan L, Christopher DJ, Smieja M, Mathai D. Adjunctive vitamin D for treatment of active tuberculosis in India: a randomised, double-blind, placebo-controlled trial. Lancet Infect Dis. 2015 May;15(5):528-34. doi: 10.1016/S1473-3099(15)70053-8. Epub 2015 Apr 8.
- TB control in IndiaLink provided by the sponsor.
Related trials for Pulmonary Tuberculosis
RecruitingPhase 4
Short-term Antibiotic Therapy in Mycobacterium Avium Complex Pulmonary Disease
Mycobacterium Avium Complex Pulmonary Disease
Active, not recruitingObservational study
Mycobacterial and Opportunistic Infections in HIV-Negative Thai and Taiwanese Patients Associated With Autoantibodies to Interferon-gamma
Nontuberculous Mycobacteria, Mycobacterium Tuberculosis
RecruitingPhase 2
BRIGHT-Child TB: Short-Course Treatment for Non-Severe Pulmonary Tuberculosis in Children
Tuberculosis
RecruitingPhase 3
A Study of Quabodepistat-containing Regimens for the Treatment of Drug-resistant Pulmonary Tuberculosis
Rifampicin-Resistant Pulmonary Tuberculosis, Multidrug-Resistant Pulmonary Tuberculosis
Recruiting
Channa Striata and Curcuma Domestica Supplementation in Patients With Active Pulmonary Tuberculosis
Pulmonary Tuberculosis
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.
Dilip Mathai, MD, FCAMS principal investigator
Christian Medical College, Vellore, India
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing A. 100,000 IU Cholecalciferol per dose of 3.3ml and B. Migliol Oil without Cholecalciferol in people with Pulmonary Tuberculosis, run by Peter Daley at 2 sites 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 5 inclusion and 5 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 6 Jul 2012. 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 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Time to sputum culture conversion (time frame: 8 weeks of treatment). 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 NCT00366470, which also lists 1 linked publication.
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 6 Jul 2012.