Crohn's DiseasePhase 4IBDVit1NCT00672763
Adjuvant Vitamin D With Corticosteroids in Active Crohn's Disease
A Phase 4 study testing Colecalciferol D3 (Vigantol Oil) and Medium chain triglycerides in people with Crohn's Disease, run by Imperial College London at 2 sites in United Kingdom.
Trial summary
The purpose of this study is to determine whether the addition of vitamin D to standard corticosteroids improves onset of remission in active Crohn's Disease, a form of Inflammatory Bowel Disease (IBD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Colecalciferol D3 (Vigantol Oil) and Medium chain triglycerides
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- May 2008to May 2010
- 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
- Active Crohn's Disease Activity (CDAI) Score >200 to 450;
- Diagnosis of IBD and distribution of disease previously confirmed
- The participant able to give informed consent form;
- Stable doses of the following concurrent IBD medications prior to inclusion:
- 5-aminosalicylates (≥4 weeks)
- Thiopurines (≥8 weeks)
- No corticosteroids (within 4 weeks)
- No biological agents (within 8 weeks).
Who cannot join
- Unable to give informed written consent;
- Co-existence of any other chronic inflammatory conditions
- Failure to meet concurrent IBD medication criteria;
- Hypercalcaemia (Corrected serum calcium > 2.66 mmol/L) or history of vitamin D hypersensitivity;
- Diagnosis of any of the flowing: active tuberculosis, sarcoidosis, hyperparathyroidism, pseudohyperparathyroidism, nephrolithiasis, silicosis, liver failure, renal failure or malignancy, active TB, sarcoidosis or lymphoma or other granulomatous disease;
- Known intolerance or contraindication to vitamin D or trial medication (i.e. corticosteroids / infliximab);
- Biochemical disturbance at enrolment: serum corrected calcium > 2.66 mmol/L) or serum creatinine >250 micromol/L;
- Pregnancy or breast-feeding.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
St. Mark's Hospital
Harrow, Middlesex
Imperial College Healthcare NHS Trust (Hammersmith, Charing Cross and St. Mary's Hospitals)
London, London
About this study
Official title: The Immunomodulatory Role of Vitamin D in Inflammatory Bowel Disease (The IBDVit Study): Double-Blind, Placebo-Controlled Trial of Adjuvant Vitamin D (Colecalciferol) With Corticosteroids in Active Crohn's Disease
The purpose of this study is to determine whether the addition of vitamin D to standard corticosteroids improves onset of remission in active Crohn's Disease, a form of Inflammatory Bowel Disease (IBD).
Read the detailed description
Crohn's Disease is a form of Inflammatory Bowel Disease (IBD). It is caused by abnormal immune-mediated gut inflammation and is both chronic and difficult to treat. Symptoms are often unpleasant (e.g. abdominal pain, diarrhoea, disfiguring fistulation) and often lead to surgery to remove diseased bowel.
There is emerging evidence that Vitamin D, a nutrient largely produced in the skin upon exposure to sun-light, may possess properties regulating the immune system in IBD. In addition, vitamin D deficiency appears common in Inflammatory Bowel Disease.
This study aims to determine if the addition of vitamin D to standard corticosteroid treatment in active Crohn's Disease helps to achieve remission (resolution of symptoms).
- Conditions
- Crohn's Disease
- Being tested
- Colecalciferol D3 (Vigantol Oil), Medium chain triglycerides
- Keywords
- Crohn's Disease, Inflammatory Bowel Disease, Vitamin D, Randomised, Placebo
- Medical subject headings
- Crohn Disease, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colecalciferol D3 (Vigantol Oil)Drug
Also called CalcichewD3Forte (Calcium and Vitamin D3), Vigantol Oil (Colecalciferol D3)
- Standard oral Prednisolone 40mg daily (or Budesonide 9mg daily) for 4 weeks;
- Supplemental calcium and vitamin D3 (CalcichewD3Forte) 1000mg and 800iU respectively daily for duration of steroid treatment;
- Colecalciferol 100,000iU orally once fortnightly for 4 weeks (2 doses).
Medium chain triglyceridesDrug
Also called CalcichewD3Forte (Calcium and Vitamin D3), Migliol Oil (Placebo)
- Standard oral Prednisolone 40mg daily (or Budesonide 9mg daily) for 4 weeks;
- Supplemental calcium and vitamin D3 (CalcichewD3Forte) 1000mg and 800iU respectively daily for duration of steroid treatment;
- Migliol Oil 5ml oral fortnightly (2 doses)
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Standard corticosteroid treatment PLUS Vitamin D3 (Colecalciferol). Receives: Drug: Colecalciferol D3 (Vigantol Oil) |
| B | Placebo comparator | Standard corticosteroid treatment PLUS placebo (Migliol Oil) Receives: Drug: Medium chain triglycerides |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Remission (CDAI score <150)
Measured: 4 Weeks
Secondary outcomes (4)
Reduction in CDAI suggestive of a clinical improvement.
Measured: Week 4
Reduction in serum C-reactive protein.
Measured: Week 4
Reduction of faecal calprotectin levels
Measured: Week 4
Clinical Remission (CDAI score <150)
Measured: Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2008 (estimated)
- Study startMay 2008
- Primary completionMay 2010 (estimated)
- Study completionMay 2010 (estimated)
Why it stopped: Unable to recruit adequate trial participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Investigators
- Andrew N Milestone, BSc(Hons) MBBS MRCP, Principal investigator, Imperial College London (Hammersmith and St. Mark's Hospitals)Subrata Ghosh, MD (Edin) FRCP, FRCP (Edin), Study chair, Imperial College London (Hammersmith Hospital)Ailsa L Hart, BA(Hons), BM BCh, MRCP, PhD, Study director, Imperial College London (St. Mark's Hospital)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00672763
- Sponsor's protocol ID
- VITDIBD1
- Other IDs
- EudraCT: 2007-006692-37
- Acronym
- IBDVit1
- Status last verified
- Jun 2011
- First submitted
- 2 May 2008
- Last updated
- 8 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Immunomodulatory Role of Vitamin D in Inflammatory Bowel Disease (The IBDVit Study): Double-Blind, Placebo-Controlled Trial of Adjuvant Vitamin D (Colecalciferol) With Corticosteroids in Active Crohn's Disease
- ClinicalTrials.gov ID
- NCT00672763
- Acronym / sponsor ID
- IBDVit1 / VITDIBD1
- Conditions
- Crohn's Disease
- Keywords
- Crohn's Disease, Inflammatory Bowel Disease, Vitamin D, Randomised, Placebo
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to recruit adequate trial participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- May 2010 (estimated)
- Study completion
- May 2010 (estimated)
- First posted
- 6 May 2008 (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 whether the addition of vitamin D to standard corticosteroids improves onset of remission in active Crohn's Disease, a form of Inflammatory Bowel Disease (IBD).
Detailed description
Crohn's Disease is a form of Inflammatory Bowel Disease (IBD). It is caused by abnormal immune-mediated gut inflammation and is both chronic and difficult to treat. Symptoms are often unpleasant (e.g. abdominal pain, diarrhoea, disfiguring fistulation) and often lead to surgery to remove diseased bowel.
There is emerging evidence that Vitamin D, a nutrient largely produced in the skin upon exposure to sun-light, may possess properties regulating the immune system in IBD. In addition, vitamin D deficiency appears common in Inflammatory Bowel Disease.
This study aims to determine if the addition of vitamin D to standard corticosteroid treatment in active Crohn's Disease helps to achieve remission (resolution of symptoms).
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 | Active comparator | Drug: Colecalciferol D3 (Vigantol Oil)Standard corticosteroid treatment PLUS Vitamin D3 (Colecalciferol). |
| B | Placebo comparator | Drug: Medium chain triglyceridesStandard corticosteroid treatment PLUS placebo (Migliol Oil) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Active Crohn's Disease Activity (CDAI) Score >200 to 450;
- Diagnosis of IBD and distribution of disease previously confirmed
- The participant able to give informed consent form;
- Stable doses of the following concurrent IBD medications prior to inclusion:
Key exclusion criteria (8 listed)
- Unable to give informed written consent;
- Co-existence of any other chronic inflammatory conditions
- Failure to meet concurrent IBD medication criteria;
- Hypercalcaemia (Corrected serum calcium > 2.66 mmol/L) or history of vitamin D hypersensitivity;
- Diagnosis of any of the flowing: active tuberculosis, sarcoidosis, hyperparathyroidism, pseudohyperparathyroidism, nephrolithiasis, silicosis, liver failure, renal failure or malignancy, active TB, sarcoidosis or lymphoma or other granulomatous disease;
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 |
|---|---|---|
| Colecalciferol D3 (Vigantol Oil)Also: CalcichewD3Forte (Calcium and Vitamin D3), Vigantol Oil (Colecalciferol D3)1. Standard oral Prednisolone 40mg daily (or Budesonide 9mg daily) for 4 weeks; 2. Supplemental calcium and vitamin D3 (CalcichewD3Forte) 1000mg and 800iU respectively daily for duration of steroid treatment; 3. Colecalciferol 100,000iU orally once fortnightly for 4 weeks (2 doses). | Drug | A |
| Medium chain triglyceridesAlso: CalcichewD3Forte (Calcium and Vitamin D3), Migliol Oil (Placebo)1. Standard oral Prednisolone 40mg daily (or Budesonide 9mg daily) for 4 weeks; 2. Supplemental calcium and vitamin D3 (CalcichewD3Forte) 1000mg and 800iU respectively daily for duration of steroid treatment; 3. Migliol Oil 5ml oral fortnightly (2 doses) | Drug | B |
Primary outcome
Clinical Remission (CDAI score <150)
Time frame: 4 Weeks
4 secondary outcomes
Reduction in CDAI suggestive of a clinical improvement.
Time frame: Week 4
Reduction in serum C-reactive protein.
Time frame: Week 4
Reduction of faecal calprotectin levels
Time frame: Week 4
Clinical Remission (CDAI score <150)
Time frame: Week 6
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2015.
Related trials for Crohn's Disease
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
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.
Andrew N Milestone, BSc(Hons) MBBS MRCP principal investigator
Imperial College London (Hammersmith and St. Mark's Hospitals)
Subrata Ghosh, MD (Edin) FRCP, FRCP (Edin) study chair
Imperial College London (Hammersmith Hospital)
Ailsa L Hart, BA(Hons), BM BCh, MRCP, PhD study director
Imperial College London (St. Mark's Hospital)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Colecalciferol D3 (Vigantol Oil) and Medium chain triglycerides in people with Crohn's Disease, run by Imperial College London at 2 sites 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 8 inclusion and 8 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: withdrawn, as of the sponsor's last update on 8 Jun 2015. 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 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. 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 was withdrawn before enrolling participants, so there are no results.
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?
Clinical Remission (CDAI score <150) (time frame: 4 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jun 2015.