Vitamin D SupplementsNCT01657656
Vitamin D Supplementations as Adjunct to Anti-Tuberculosis Drugs in Mongolia
A study testing Vitamin D in people with Vitamin D Supplements and Tuberculosis, run by Harvard School of Public Health (HSPH) at 1 site in Mongolia.
Trial summary
Hypothesis That improving vitamin D status among TB patients will speed the pace of bacteriological cure, and will enhance immune responses to TB infection Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Vitamin D Supplements, Tuberculosis, Sputum
- What is being tested?
- Vitamin D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 350 participants
- Where
- 1 siteMongolia
- Study dates
- Oct 2012to Jul 2014
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sputum positive TB patients
Who cannot join
- We will exclude those with abnormal LFTs at baseline (2.5 times upper limit of normal), as they will be at higher risk of developing drug-induced hepatitis
Trial locations and contacts
1 site in 1 country.
About this study
Hypothesis
That improving vitamin D status among TB patients will speed the pace of bacteriological cure, and will enhance immune responses to TB infection
Read the detailed description
Tuberculosis (TB) will be the world's largest single cause of death from infection for the 30-year period between 1990 and 2020. More than 95% of TB cases, and deaths due to TB, occur in developing countries. Mongolia is one of the countries with the highest tuberculosis burdens in the Western Pacific region. In addition, vitamin D deficiency is endemic in Mongolia. We propose to determine the efficacy of vitamin D supplements, as an adjunct to multidrug therapy, in enhancing the anti-microbial immune response to TB, a finding that could lead to the development of shorter drug regimens, and thus more efficient and effective TB treatment protocols.
We propose to conduct a double blind, placebo controlled, randomized clinical trial to test the effect of a daily vitamin D supplementation on the ability of subjects to control TB infection.
The Primary Endpoint: The primary endpoint will be: time to sputum culture conversion from positive to negative. The number of days to sputum conversion will be measured, in both the intervention and control groups, starting on the date that treatment is begun. Sputum samples will be collected and cultured every two weeks thereafter. The date of conversion from positive to negative, for each subject, will be the date halfway between the date of the last culture-positive sputum and the first culture-negative one.
Secondary Endpoints:
Bacteriologic secondary endpoints, cell-mediated immune function endpoints and BMI.
- Conditions
- Vitamin D Supplements, Tuberculosis, Sputum, Cytokines, Immunity
- Being tested
- Vitamin D
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D group | Experimental | Vitamin D supplement by Tishcon Receives: Dietary Supplement: Vitamin D |
| Control group | Placebo comparator | Identically appearing capsules Receives: Dietary Supplement: Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint will be time to sputum culture conversion from positive to negative.
Measured: Eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2012 (estimated)
- Study startOct 2012
- Primary completionMay 2014
- 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 Vitamin D SupplementsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ganmaa Davaasambuu, Harvard School of Public Health (HSPH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01657656
- Sponsor's protocol ID
- R00HL089710
- Status last verified
- Jul 2014
- First submitted
- 2 Aug 2012
- Last updated
- 30 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ganmaa D, Munkhzul B, Fawzi W, Spiegelman D, Willett WC, Bayasgalan P, Baasansuren E, Buyankhishig B, Oyun-Erdene S, Jolliffe DA, Xenakis T, Bromage S, Bloom BR, Martineau AR. High-Dose Vitamin D3 during Tuberculosis Treatment in Mongolia. A Randomized Controlled Trial. Am J Respir Crit Care Med. 2017 Sep 1;196(5):628-637. doi: 10.1164/rccm.201705-0936OC.
PubMed 28692301
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Supplementations as Adjunct to Anti-Tuberculosis Drugs in Mongolia
- ClinicalTrials.gov ID
- NCT01657656
- Acronym / sponsor ID
- R00HL089710
- Conditions
- Vitamin D Supplements, Tuberculosis, Sputum, Cytokines, Immunity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Study start
- Oct 2012
- Primary completion
- May 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 6 Aug 2012 (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.
Hypothesis
That improving vitamin D status among TB patients will speed the pace of bacteriological cure, and will enhance immune responses to TB infection
Detailed description
Tuberculosis (TB) will be the world's largest single cause of death from infection for the 30-year period between 1990 and 2020. More than 95% of TB cases, and deaths due to TB, occur in developing countries. Mongolia is one of the countries with the highest tuberculosis burdens in the Western Pacific region. In addition, vitamin D deficiency is endemic in Mongolia. We propose to determine the efficacy of vitamin D supplements, as an adjunct to multidrug therapy, in enhancing the anti-microbial immune response to TB, a finding that could lead to the development of shorter drug regimens, and thus more efficient and effective TB treatment protocols.
We propose to conduct a double blind, placebo controlled, randomized clinical trial to test the effect of a daily vitamin D supplementation on the ability of subjects to control TB infection.
The Primary Endpoint: The primary endpoint will be: time to sputum culture conversion from positive to negative. The number of days to sputum conversion will be measured, in both the intervention and control groups, starting on the date that treatment is begun. Sputum samples will be collected and cultured every two weeks thereafter. The date of conversion from positive to negative, for each subject, will be the date halfway between the date of the last culture-positive sputum and the first culture-negative one.
Secondary Endpoints:
Bacteriologic secondary endpoints, cell-mediated immune function endpoints and BMI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D group | Experimental | Dietary Supplement: Vitamin DVitamin D supplement by Tishcon |
| Control group | Placebo comparator | Dietary Supplement: Vitamin DIdentically appearing capsules |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Sputum positive TB patients
Key exclusion criteria (1 listed)
- We will exclude those with abnormal LFTs at baseline (2.5 times upper limit of normal), as they will be at higher risk of developing drug-induced hepatitis
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 | Dietary supplement | Control group, Vitamin D group |
Primary outcome
The primary endpoint will be time to sputum culture conversion from positive to negative.
Time frame: Eight 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 30 Jul 2014.
- Derived from this study: PubMed 28692301Ganmaa D, Munkhzul B, Fawzi W, Spiegelman D, Willett WC, Bayasgalan P, Baasansuren E, Buyankhishig B, Oyun-Erdene S, Jolliffe DA, Xenakis T, Bromage S, Bloom BR, Martineau AR. High-Dose Vitamin D3 during Tuberculosis Treatment in Mongolia. A Randomized Controlled Trial. Am J Respir Crit Care Med. 2017 Sep 1;196(5):628-637. doi: 10.1164/rccm.201705-0936OC.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D in people with Vitamin D Supplements and Tuberculosis, run by Harvard School of Public Health (HSPH) at 1 site in Mongolia.
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 1 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 30 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 Mongolia. 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?
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 endpoint will be time to sputum culture conversion from positive to negative. (time frame: Eight weeks). 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 NCT01657656, 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 30 Jul 2014.