TuberculosisNCT00157066
Effects of Vitamin D Supplementation on Antimycobacterial Immunity
A study testing Ergocalciferol in people with Tuberculosis, run by Barts & The London NHS Trust at 1 site in United Kingdom.
Trial summary
The purpose of this study is to determine how vitamin D supplementation (ergocalciferol) affects the immune response to mycobacterial infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tuberculosis
- What is being tested?
- Ergocalciferol
- How many people
- 230 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2002to Sep 2006
- 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 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Adult
- Tuberculosis (TB) contact or TB patient
Who cannot join
- Pregnancy
- Breastfeeding
- Hyperparathyroidism
- Sarcoidosis
- Renal failure
- HIV infection
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Tuberculosis Clinic, Newham Chest Clinic
London, E7 8QP
About this study
Official title: Effects of Vitamin D Supplementation on Antimycobacterial Immunity: A Randomised Trial
The purpose of this study is to determine how vitamin D supplementation (ergocalciferol) affects the immune response to mycobacterial infection.
- Conditions
- Tuberculosis
- Being tested
- Ergocalciferol
- Keywords
- Latent tuberculosis infection, Active tuberculosis infection
- Medical subject headings
- Tuberculosis, Latent Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErgocalciferolDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacillus Calmette-Guerin (BCG) lux whole blood assay
Secondary outcomes (1)
Antigen-stimulated whole blood interferon gamma production
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startDec 2002
- Study completionSep 2006
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.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 230 participants
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Imperial College London, University of Cape Town, Newham Chest Clinic, London E7 8QP, UK, Northwick Park Hospital, Harrow, UK, Department of Clinical Biochemistry, Homerton Hospital, London E9 6SR, UK, Environmental Health Department, London Borough of Newham, London E15 4SF, UK, Wellcome Trust
- Investigators
- Adrian R Martineau, B Med Sci, MBBS, DTM&H, MRCP, Principal investigator, Centre for Health Sciences, Barts and The London, QMUL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00157066
- Sponsor's protocol ID
- AM1
- Status last verified
- Jan 2007
- First submitted
- 8 Sep 2005
- Last updated
- 8 Jan 2007
- Results posted
- No
Publications
Martineau AR, Wilkinson RJ, Wilkinson KA, Newton SM, Kampmann B, Hall BM, Packe GE, Davidson RN, Eldridge SM, Maunsell ZJ, Rainbow SJ, Berry JL, Griffiths CJ. A single dose of vitamin D enhances immunity to mycobacteria. Am J Respir Crit Care Med. 2007 Jul 15;176(2):208-13. doi: 10.1164/rccm.200701-007OC. Epub 2007 Apr 26.
PubMed 17463418
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Vitamin D Supplementation on Antimycobacterial Immunity: A Randomised Trial
- ClinicalTrials.gov ID
- NCT00157066
- Acronym / sponsor ID
- AM1
- Conditions
- Tuberculosis
- Keywords
- Latent tuberculosis infection, Active tuberculosis infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Collaborators
- Imperial College London, University of Cape Town, Newham Chest Clinic, London E7 8QP, UK, Northwick Park Hospital, Harrow, UK, Department of Clinical Biochemistry, Homerton Hospital, London E9 6SR, UK, Environmental Health Department, London Borough of Newham, London E15 4SF, UK, Wellcome Trust
- Study start
- Dec 2002
- Study completion
- Sep 2006
- First posted
- 12 Sep 2005 (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 purpose of this study is to determine how vitamin D supplementation (ergocalciferol) affects the immune response to mycobacterial infection.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult
- Tuberculosis (TB) contact or TB patient
Key exclusion criteria (6 listed)
- Pregnancy
- Breastfeeding
- Hyperparathyroidism
- Sarcoidosis
- Renal failure
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 |
|---|---|---|
| Ergocalciferol | Drug | – |
Primary outcome
Bacillus Calmette-Guerin (BCG) lux whole blood assay
1 secondary outcome
Antigen-stimulated whole blood interferon gamma production
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 8 Jan 2007.
- Derived from this study: PubMed 17463418Martineau AR, Wilkinson RJ, Wilkinson KA, Newton SM, Kampmann B, Hall BM, Packe GE, Davidson RN, Eldridge SM, Maunsell ZJ, Rainbow SJ, Berry JL, Griffiths CJ. A single dose of vitamin D enhances immunity to mycobacteria. Am J Respir Crit Care Med. 2007 Jul 15;176(2):208-13. doi: 10.1164/rccm.200701-007OC. Epub 2007 Apr 26.
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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.
Adrian R Martineau, B Med Sci, MBBS, DTM&H, MRCP principal investigator
Centre for Health Sciences, Barts and The London, QMUL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ergocalciferol in people with Tuberculosis, run by Barts & The London NHS Trust at 1 site in United Kingdom.
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 6 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 8 Jan 2007. 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 United Kingdom. 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?
Bacillus Calmette-Guerin (BCG) lux whole blood assay. 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 NCT00157066, 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 8 Jan 2007.