Allograft RejectionPhase 4VIT001NCT01212406
Vitamin D in Bronchiolitis Obliterans Syndrome
A Phase 4 study testing Vitamin D in people with Allograft Rejection and Lung Transplantation, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Vitamin D deficiency occurs in around 50% of our transplant population. Preventive treatment with Vitamin D (D-cure) can reduce the prevalence of Bronchiolitis Obliterans Syndrome after lung transplantation Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allograft Rejection, Lung Transplantation, Bronchiolitis Obliterans
- What is being tested?
- Vitamin D
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2010to Aug 2015
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stable LTx recipients at discharge after transplantation.
- Signed informed consent
- Adult (age at least 18 years old at moment of transplantation)
- Able to take oral medication
Who cannot join
- Prolonged and/or complicated Intensive care unit-course after transplantation.
- Early (<30 days post-transplant) post-operative death
- Major suture problems (airway stenosis or stent)
- Retransplantation (lung)
- Previous transplantation (solid organ)
- Multi-organ transplantation (lung+ other solid organ)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Double Blind Placebo Controlled Trial With Vitamin D to Prevent Bronchiolitis Obliterans Syndrome After Lung Transplantation
Vitamin D deficiency occurs in around 50% of our transplant population. Preventive treatment with Vitamin D (D-cure) can reduce the prevalence of Bronchiolitis Obliterans Syndrome after lung transplantation
Read the detailed description
- Prospective, interventional, randomized, double-blind, placebo-controlled trial.
- Clinical setting (tertiary University Hospital).
- Investigator-driven, no pharmaceutical sponsor.
- Lung transplant recipients.
- Add-on of study-drug (placebo or vitamin D) to 'standard of care' (standardized, routine immunosuppressive and infectious prophylactic protocol).
- 1:1 inclusion ratio (placebo:Vitamin D).
- Randomisation at discharge after informed consent.
- Being tested
- Vitamin D
- Keywords
- Organ rejection, Lung transplantation, Bronchiolitis Obliterans, Vitamin D, Prevention
- Medical subject headings
- Bronchiolitis Obliterans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDrug
Also called D-Cure
Every month 100.000 units of vitamin D in syringe Exacta-Med Oral Dispenser during 2 years and re-evaluation after 3 years
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Olive oil Receives: Drug: Vitamin D |
| Vitamin D | Experimental | Addition of D-cure (100.000U) to standard care Receives: Drug: Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Bronchiolitis Obliterans syndrome (BOS) (grade 1) at 2 years after transplantation
BOS= decline in forced expiratory volume in 1 second (FEV1) with at least 80% compared to the best post-operative value
Measured: 2 years after transplantation
Prevalence of BOS (grade 1) at 3 years after transplantation
her-evaluation of data
Measured: 3 years after transplantation
Secondary outcomes (5)
Bronchoalveolar lavage
cellularity, protein and mRNA concentration and microbiology
Measured: during 2 and 3y of follow-up
Peripheral blood
Protein and mRNA concentration, cellularity
Measured: During 2 and 3 years of follow-up
Rejection rates
Acute rejection and lymphocytic bronchiolitis rates
Measured: During 2 and 3 years of follow-up
Reflux
clinical and biochemical approach
Measured: During 2 and 3 years of follow-up
Infection rates
cytomegalovirus (CMV) and non- CMV infection rates
Measured: During 2 and 3 years of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2010 (estimated)
- Study startOct 2010
- Primary completionSep 2013
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Allograft RejectionStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- KU Leuven
- Responsible party
- Sponsor
- Investigators
- Geert M Verleden, MD, PhD, Principal investigator, UZ gasthuisberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01212406
- Sponsor's protocol ID
- VIT001
- Acronym
- VIT001
- Status last verified
- Oct 2013
- First submitted
- 28 Sep 2010
- Last updated
- 11 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ramirez AM, Wongtrakool C, Welch T, Steinmeyer A, Zugel U, Roman J. Vitamin D inhibition of pro-fibrotic effects of transforming growth factor beta1 in lung fibroblasts and epithelial cells. J Steroid Biochem Mol Biol. 2010 Feb 15;118(3):142-50. doi: 10.1016/j.jsbmb.2009.11.004. Epub 2009 Nov 17.
PubMed 19931390Zittermann A, Schleithoff SS, Gotting C, Fuchs U, Kuhn J, Kleesiek K, Tenderich G, Koerfer R. Calcitriol deficiency and 1-year mortality in cardiac transplant recipients. Transplantation. 2009 Jan 15;87(1):118-24. doi: 10.1097/TP.0b013e31818c2708.
PubMed 19136901Janssens W, Bouillon R, Claes B, Carremans C, Lehouck A, Buysschaert I, Coolen J, Mathieu C, Decramer M, Lambrechts D. Vitamin D deficiency is highly prevalent in COPD and correlates with variants in the vitamin D-binding gene. Thorax. 2010 Mar;65(3):215-20. doi: 10.1136/thx.2009.120659. Epub 2009 Dec 8.
PubMed 19996341Vanaudenaerde BM, Meyts I, Vos R, Geudens N, De Wever W, Verbeken EK, Van Raemdonck DE, Dupont LJ, Verleden GM. A dichotomy in bronchiolitis obliterans syndrome after lung transplantation revealed by azithromycin therapy. Eur Respir J. 2008 Oct;32(4):832-43. doi: 10.1183/09031936.00134307.
PubMed 18827151Estenne M, Maurer JR, Boehler A, Egan JJ, Frost A, Hertz M, Mallory GB, Snell GI, Yousem S. Bronchiolitis obliterans syndrome 2001: an update of the diagnostic criteria. J Heart Lung Transplant. 2002 Mar;21(3):297-310. doi: 10.1016/s1053-2498(02)00398-4. No abstract available.
PubMed 11897517
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double Blind Placebo Controlled Trial With Vitamin D to Prevent Bronchiolitis Obliterans Syndrome After Lung Transplantation
- ClinicalTrials.gov ID
- NCT01212406
- Acronym / sponsor ID
- VIT001 / VIT001
- Keywords
- Organ rejection, Lung transplantation, Bronchiolitis Obliterans, Vitamin D, Prevention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- KU Leuven
- Study start
- Oct 2010
- Primary completion
- Sep 2013 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 30 Sep 2010 (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.
Vitamin D deficiency occurs in around 50% of our transplant population. Preventive treatment with Vitamin D (D-cure) can reduce the prevalence of Bronchiolitis Obliterans Syndrome after lung transplantation
Detailed description
- Prospective, interventional, randomized, double-blind, placebo-controlled trial.
- Clinical setting (tertiary University Hospital).
- Investigator-driven, no pharmaceutical sponsor.
- Lung transplant recipients.
- Add-on of study-drug (placebo or vitamin D) to 'standard of care' (standardized, routine immunosuppressive and infectious prophylactic protocol).
- 1:1 inclusion ratio (placebo:Vitamin D).
- Randomisation at discharge after informed consent.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Vitamin DOlive oil |
| Vitamin D | Experimental | Drug: Vitamin DAddition of D-cure (100.000U) to standard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Stable LTx recipients at discharge after transplantation.
- Signed informed consent
- Adult (age at least 18 years old at moment of transplantation)
- Able to take oral medication
Key exclusion criteria (6 listed)
- Prolonged and/or complicated Intensive care unit-course after transplantation.
- Early (<30 days post-transplant) post-operative death
- Major suture problems (airway stenosis or stent)
- Retransplantation (lung)
- Previous transplantation (solid organ)
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 DAlso: D-CureEvery month 100.000 units of vitamin D in syringe Exacta-Med Oral Dispenser during 2 years and re-evaluation after 3 years | Drug | Placebo, Vitamin D |
Primary outcome
Prevalence of Bronchiolitis Obliterans syndrome (BOS) (grade 1) at 2 years after transplantation
Time frame: 2 years after transplantation
BOS= decline in forced expiratory volume in 1 second (FEV1) with at least 80% compared to the best post-operative value
Prevalence of BOS (grade 1) at 3 years after transplantation
Time frame: 3 years after transplantation
her-evaluation of data
5 secondary outcomes
Bronchoalveolar lavage
Time frame: during 2 and 3y of follow-up
Peripheral blood
Time frame: During 2 and 3 years of follow-up
Rejection rates
Time frame: During 2 and 3 years of follow-up
Reflux
Time frame: During 2 and 3 years of follow-up
Infection rates
Time frame: During 2 and 3 years of follow-up
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 Nov 2015.
- Background: PubMed 19931390Ramirez AM, Wongtrakool C, Welch T, Steinmeyer A, Zugel U, Roman J. Vitamin D inhibition of pro-fibrotic effects of transforming growth factor beta1 in lung fibroblasts and epithelial cells. J Steroid Biochem Mol Biol. 2010 Feb 15;118(3):142-50. doi: 10.1016/j.jsbmb.2009.11.004. Epub 2009 Nov 17.
- Background: PubMed 19136901Zittermann A, Schleithoff SS, Gotting C, Fuchs U, Kuhn J, Kleesiek K, Tenderich G, Koerfer R. Calcitriol deficiency and 1-year mortality in cardiac transplant recipients. Transplantation. 2009 Jan 15;87(1):118-24. doi: 10.1097/TP.0b013e31818c2708.
- Background: PubMed 19996341Janssens W, Bouillon R, Claes B, Carremans C, Lehouck A, Buysschaert I, Coolen J, Mathieu C, Decramer M, Lambrechts D. Vitamin D deficiency is highly prevalent in COPD and correlates with variants in the vitamin D-binding gene. Thorax. 2010 Mar;65(3):215-20. doi: 10.1136/thx.2009.120659. Epub 2009 Dec 8.
- Background: PubMed 18827151Vanaudenaerde BM, Meyts I, Vos R, Geudens N, De Wever W, Verbeken EK, Van Raemdonck DE, Dupont LJ, Verleden GM. A dichotomy in bronchiolitis obliterans syndrome after lung transplantation revealed by azithromycin therapy. Eur Respir J. 2008 Oct;32(4):832-43. doi: 10.1183/09031936.00134307.
- Background: PubMed 11897517Estenne M, Maurer JR, Boehler A, Egan JJ, Frost A, Hertz M, Mallory GB, Snell GI, Yousem S. Bronchiolitis obliterans syndrome 2001: an update of the diagnostic criteria. J Heart Lung Transplant. 2002 Mar;21(3):297-310. doi: 10.1016/s1053-2498(02)00398-4. No abstract available.
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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.
Geert M Verleden, MD, PhD principal investigator
UZ gasthuisberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vitamin D in people with Allograft Rejection and Lung Transplantation, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 4 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 11 Nov 2015. 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 Belgium. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Prevalence of Bronchiolitis Obliterans syndrome (BOS) (grade 1) at 2 years after transplantation (time frame: 2 years after transplantation). The study lists 2 primary outcomes in all. 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 NCT01212406, which also lists 5 linked publications.
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 Nov 2015.