TuberculosisPhase 2NCT00918086
Impact of Vitamin D Supplementation on Host Immunity to Mycobacterium Tuberculosis and Response to Treatment
A Phase 2 study testing Vitamin D pill in people with Tuberculosis, run by Emory University at 1 site in Georgia.
Trial summary
Tuberculosis bacterium (TB) is a germ that can infect any part of the human body, especially the lungs. Vitamin D is a hormone present in humans that regulates blood electrolytes such as calcium and phosphate. There is new information that links vitamin D to the functioning of our immune system. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis
- What is being tested?
- Vitamin D pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 199 participants
- Where
- 1 siteGeorgia
- Study dates
- Jul 2009to Jul 2014
- Phase
- Phase 2
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient is age > 18 years;
- Patient has documented new case of smear-positive pulmonary TB;
- Patient has received ≤ 1 week of anti-TB therapy;
- The patient will receive anti-TB therapy in Tbilisi;
- Patient has provided informed consent.
Who cannot join
- Patient has had > 30 days of lifetime TB therapy;
- Patient is currently pregnant or lactating;
- Patient has a history of organ transplant;
- Patient has a history of cancer in past 5 years (ineligibility criteria does not include non-melanoma skin cancer);
- Patient has a history of seizures;
- Patient has a history of hypercalcemia;
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- Patient has a history of hyperparathyroidism;
- Patient has a history of sarcoidosis;
- Patient has a history of nephrolithiasis (renal stones);
- Patient has taken oral corticosteroids in the past 30 days;
- Patient is currently using cytotoxic or immunosuppressive drugs;
- Patient currently has significant renal dysfunction (defined as a serum creatinine of >250mmol/L);
- Patient requires dialysis therapy;
- Patient has a history of cirrhosis;
- Patient is currently incarcerated;
- Patient is not able to complete all study visits in at the NCTBLD in Tbilisi.
Trial locations and contacts
1 site in 1 country.
Georgia1 site
National Center for tuberculosis and Lung diseases
Tbilisi, 0101
About this study
Official title: Impact of Vitamin D Supplementation on Host Immunity to Mycobacterium Tuberculosis and Response to Treatment: Building Translational Research Capacity in Nutrition and Infectious Diseases in the Republic of Georgia
Tuberculosis bacterium (TB) is a germ that can infect any part of the human body, especially the lungs. Vitamin D is a hormone present in humans that regulates blood electrolytes such as calcium and phosphate. There is new information that links vitamin D to the functioning of our immune system. The purpose of the study is to find out how vitamin D affects the immune system of patients with TB. We want to find out if correcting low vitamin D levels, in addition to getting standard therapy for TB, will help the immune system fight off TB infection more effectively.
The study will be done at the Georgia National Center for Tuberculosis and Lung Diseases (NCTBLD) in Tbilisi, Republic of Georgia. 220 patients with tuberculosis and 80 family members or household contacts of patients with tuberculosis will be participating in this study. TB patients, already receiving standard TB therapy, will be randomly assigned to either receive the Vitamin D pill or a placebo for a total of sixteen weeks. Neither the subject nor the investigator will know whether the subject has received the Vitamin D or the inactive placebo.The subject will orally consume the Vitamin D/placebo tablet 3 times a week for the 1st 8 weeks (while in hospital) and then once every other week for the last 8 weeks( during out-patient visits to the hospital).
The main study hypothesis is that Vitamin D supplementation helps patients with tuberculosis, who are on standard anti TB antibiotic therapy, get better faster.
Read the detailed description
This is a double-blind, randomized, controlled clinical trial on the clinical efficacy and antimicrobial mechanisms of oral high dose vitamin D3 therapy three times weekly given for 8 weeks followed by the same vitamin D dose given every other week for a subsequent 8 weeks (n=129) versus placebo (n=129) in newly diagnosed Georgian patients with pulmonary TB.
The trial is also designed to obtain needed information on vitamin D status and general nutritional status in TB patients in Georgia, explore vitamin D regulation of the endogenous antimicrobial peptide cathelicidin/LL-37 in human tissues, and obtain hypothesis-generating data on the potential role of cathelicidin/LL-37 as a mechanism for the anti-mycobacterial effects of vitamin D in humans.
The potential study subjects will be identified and clinically monitored by clinical study coordinators after diagnosis by standard methods (compatible signs and symptoms, positive sputum AFB smear and culture, chest X-ray). Medical records of all patients with newly diagnosed tuberculosis registered for treatment at the NCTBLD in Tbilisi will be screened for eligibility for participation in the study. Written informed consent will be obtained from patients who met eligibility criteria and agreed to participate in the study prior to the subject undergoing any study-related procedure. Participation in study will involve a total of seven study visits (one baseline and six follow up visits.
TB patients will otherwise be conventionally treated with anti-TB drug regimens using the DOTS protocols: an initial 2 month in-hospital intensive phase with daily treatment with oral rifampicin, isoniazid, pyrazinamide and ethambutol, followed by an outpatient continuation phase for 4 months with rifampicin and isoniazid only, given 3 times per week. Given data that TB disease itself is associated with vitamin D depletion we will also recruit 80 otherwise healthy, adult family members of the pulmonary TB patients as a pilot substudy. Family members recruited will be those accompanying the TB patient to clinic.
- Conditions
- Tuberculosis
- Being tested
- Vitamin D pill, Placebo
- Keywords
- Vitamin D, Tuberculosis
- 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 pillDietary supplement
Oral tablet taken for 16 weeks
PlaceboDietary supplement
An inactive pill that looks and tastes like the Vitamin D pill
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D pill | Experimental | Not described Receives: Dietary Supplement: Vitamin D pill |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome for this intent-to-treat trial is the time to Mycobacterium tuberculosis sputum culture conversion to negative
Measured: Up to 16 weeks from therapy start date
Secondary outcomes (1)
Sputum culture result (positive or negative)
Measured: 8 weeks after therapy start date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2009 (estimated)
- Study startJul 2009
- Primary completionSep 2012
- Study completionJul 2014
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 TuberculosisStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas R. Ziegler, MD, Emory University
- Investigators
- Thomas R Ziegler, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00918086
- Sponsor's protocol ID
- IRB00014641
- Other IDs
- Vitamin D Georgia Study
- Status last verified
- Jul 2014
- First submitted
- 10 Jun 2009
- Last updated
- 11 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Tukvadze N, Sanikidze E, Kipiani M, Hebbar G, Easley KA, Shenvi N, Kempker RR, Frediani JK, Mirtskhulava V, Alvarez JA, Lomtadze N, Vashakidze L, Hao L, Del Rio C, Tangpricha V, Blumberg HM, Ziegler TR. High-dose vitamin D3 in adults with pulmonary tuberculosis: a double-blind randomized controlled trial. Am J Clin Nutr. 2015 Nov;102(5):1059-69. doi: 10.3945/ajcn.115.113886. Epub 2015 Sep 23.
PubMed 26399865
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Vitamin D Supplementation on Host Immunity to Mycobacterium Tuberculosis and Response to Treatment: Building Translational Research Capacity in Nutrition and Infectious Diseases in the Republic of Georgia
- ClinicalTrials.gov ID
- NCT00918086
- Acronym / sponsor ID
- IRB00014641
- Conditions
- Tuberculosis
- Keywords
- Vitamin D, Tuberculosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Sep 2012 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 11 Jun 2009 (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.
Tuberculosis bacterium (TB) is a germ that can infect any part of the human body, especially the lungs. Vitamin D is a hormone present in humans that regulates blood electrolytes such as calcium and phosphate. There is new information that links vitamin D to the functioning of our immune system. The purpose of the study is to find out how vitamin D affects the immune system of patients with TB. We want to find out if correcting low vitamin D levels, in addition to getting standard therapy for TB, will help the immune system fight off TB infection more effectively.
The study will be done at the Georgia National Center for Tuberculosis and Lung Diseases (NCTBLD) in Tbilisi, Republic of Georgia. 220 patients with tuberculosis and 80 family members or household contacts of patients with tuberculosis will be participating in this study. TB patients, already receiving standard TB therapy, will be randomly assigned to either receive the Vitamin D pill or a placebo for a total of sixteen weeks. Neither the subject nor the investigator will know whether the subject has received the Vitamin D or the inactive placebo.The subject will orally consume the Vitamin D/placebo tablet 3 times a week for the 1st 8 weeks (while in hospital) and then once every other week for the last 8 weeks( during out-patient visits to the hospital).
The main study hypothesis is that Vitamin D supplementation helps patients with tuberculosis, who are on standard anti TB antibiotic therapy, get better faster.
Detailed description
This is a double-blind, randomized, controlled clinical trial on the clinical efficacy and antimicrobial mechanisms of oral high dose vitamin D3 therapy three times weekly given for 8 weeks followed by the same vitamin D dose given every other week for a subsequent 8 weeks (n=129) versus placebo (n=129) in newly diagnosed Georgian patients with pulmonary TB.
The trial is also designed to obtain needed information on vitamin D status and general nutritional status in TB patients in Georgia, explore vitamin D regulation of the endogenous antimicrobial peptide cathelicidin/LL-37 in human tissues, and obtain hypothesis-generating data on the potential role of cathelicidin/LL-37 as a mechanism for the anti-mycobacterial effects of vitamin D in humans.
The potential study subjects will be identified and clinically monitored by clinical study coordinators after diagnosis by standard methods (compatible signs and symptoms, positive sputum AFB smear and culture, chest X-ray). Medical records of all patients with newly diagnosed tuberculosis registered for treatment at the NCTBLD in Tbilisi will be screened for eligibility for participation in the study. Written informed consent will be obtained from patients who met eligibility criteria and agreed to participate in the study prior to the subject undergoing any study-related procedure. Participation in study will involve a total of seven study visits (one baseline and six follow up visits.
TB patients will otherwise be conventionally treated with anti-TB drug regimens using the DOTS protocols: an initial 2 month in-hospital intensive phase with daily treatment with oral rifampicin, isoniazid, pyrazinamide and ethambutol, followed by an outpatient continuation phase for 4 months with rifampicin and isoniazid only, given 3 times per week. Given data that TB disease itself is associated with vitamin D depletion we will also recruit 80 otherwise healthy, adult family members of the pulmonary TB patients as a pilot substudy. Family members recruited will be those accompanying the TB patient to clinic.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D pill | Experimental | Dietary Supplement: Vitamin D pill |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient is age > 18 years;
- Patient has documented new case of smear-positive pulmonary TB;
- Patient has received ≤ 1 week of anti-TB therapy;
- The patient will receive anti-TB therapy in Tbilisi;
- Patient has provided informed consent.
Key exclusion criteria (16 listed)
- Patient has had > 30 days of lifetime TB therapy;
- Patient is currently pregnant or lactating;
- Patient has a history of organ transplant;
- Patient has a history of cancer in past 5 years (ineligibility criteria does not include non-melanoma skin cancer);
- Patient has a history of seizures;
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 pillOral tablet taken for 16 weeks | Dietary supplement | Vitamin D pill |
| PlaceboAn inactive pill that looks and tastes like the Vitamin D pill | Dietary supplement | Placebo |
Primary outcome
The primary outcome for this intent-to-treat trial is the time to Mycobacterium tuberculosis sputum culture conversion to negative
Time frame: Up to 16 weeks from therapy start date
1 secondary outcome
Sputum culture result (positive or negative)
Time frame: 8 weeks after therapy start date
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 11 Jul 2014.
- Derived from this study: PubMed 26399865Tukvadze N, Sanikidze E, Kipiani M, Hebbar G, Easley KA, Shenvi N, Kempker RR, Frediani JK, Mirtskhulava V, Alvarez JA, Lomtadze N, Vashakidze L, Hao L, Del Rio C, Tangpricha V, Blumberg HM, Ziegler TR. High-dose vitamin D3 in adults with pulmonary tuberculosis: a double-blind randomized controlled trial. Am J Clin Nutr. 2015 Nov;102(5):1059-69. doi: 10.3945/ajcn.115.113886. Epub 2015 Sep 23.
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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.
Thomas R Ziegler, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vitamin D pill in people with Tuberculosis, run by Emory University at 1 site in Georgia.
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 16 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 11 Jul 2014. 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 Georgia. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The primary outcome for this intent-to-treat trial is the time to Mycobacterium tuberculosis sputum culture conversion to negative (time frame: Up to 16 weeks from therapy start date). 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 NCT00918086, 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 11 Jul 2014.