Crohns DiseasePhase 2/3NCT00132184
Vitamin D Treatment for Crohn´s Disease
A Phase 2/3 study testing Vitamin D in people with Crohns Disease, run by University of Aarhus at 4 sites in Denmark.
Trial summary
The purpose of this study is to examine whether vitamin D treatment is effective in Crohn's disease. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Crohns Disease
- What is being tested?
- Vitamin D
- How many people
- 110 participants
- Where
- 4 sitesDenmark
- Study dates
- Sep 2005to Feb 2008
- Phase
- Phase 2/3
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Crohn's disease
- Inactive Crohn's disease for at least 4 weeks
- Crohn's Disease Activity Index (CDAI) < 150
- C-reactive protein within normal range
- Serum albumin within normal range
Who cannot join
- Hypercalcemia
- Short bowel syndrome
- Pregnancy
Trial locations and contacts
4 sites in 1 country.
Denmark4 sites
Aarhus University Hospital, Department V
Aarhus, 8000
Hospital of Horsens
Horsens, 8700
Hospital of Randers
Randers, 8900
Hospital of Silkeborg
Silkeborg, 8600
About this study
Official title: Remission Keeping and Remission Inducing Effect by Vitamin-D in Crohns Disease, and in Vitro Vitamin-D Mediated T-Cell Immunomodulation
The purpose of this study is to examine whether vitamin D treatment is effective in Crohn's disease.
Read the detailed description
Crohns Disease is an inflammatory disease of primarily the small intestine and colon.
In recent years scientists have hypothesized that low blood vitamin-D levels play a role in the development of autoimmune diseases, including Crohns disease. The purpose of this study is to examine whether vitamin-D is effective in keeping remission in inactive Crohns Disease (double blind placebo controlled trial). The patients who have active disease in the placebo group (reach primary endpoint), will in an open setting receive a higher single dose vitamin-D and the effect will be measured within 4 weeks.
- Conditions
- Crohns Disease
- Being tested
- Vitamin D
- Keywords
- Vitamin D, Crohns Disease
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse rate within 1 year treatment; CDAI>220
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2005 (estimated)
- Study startSep 2005
- Study completionFeb 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohns DiseaseStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 110 participants
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Investigators
- Jens F. Dahlerup, MD, DrMedSc, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00132184
- Sponsor's protocol ID
- 2005-001216-50
- Other IDs
- 2005
- Status last verified
- Apr 2007
- First submitted
- 18 Aug 2005
- Last updated
- 13 Apr 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remission Keeping and Remission Inducing Effect by Vitamin-D in Crohns Disease, and in Vitro Vitamin-D Mediated T-Cell Immunomodulation
- ClinicalTrials.gov ID
- NCT00132184
- Acronym / sponsor ID
- 2005-001216-50
- Conditions
- Crohns Disease
- Keywords
- Vitamin D, Crohns Disease
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Sep 2005
- Study completion
- Feb 2008 (estimated)
- First posted
- 19 Aug 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 examine whether vitamin D treatment is effective in Crohn's disease.
Detailed description
Crohns Disease is an inflammatory disease of primarily the small intestine and colon.
In recent years scientists have hypothesized that low blood vitamin-D levels play a role in the development of autoimmune diseases, including Crohns disease. The purpose of this study is to examine whether vitamin-D is effective in keeping remission in inactive Crohns Disease (double blind placebo controlled trial). The patients who have active disease in the placebo group (reach primary endpoint), will in an open setting receive a higher single dose vitamin-D and the effect will be measured within 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Crohn's disease
- Inactive Crohn's disease for at least 4 weeks
- Crohn's Disease Activity Index (CDAI) < 150
- C-reactive protein within normal range
- Serum albumin within normal range
Key exclusion criteria (3 listed)
- Hypercalcemia
- Short bowel syndrome
- Pregnancy
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 | Drug | – |
Primary outcome
Relapse rate within 1 year treatment; CDAI>220
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2007.
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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.
Jens F. Dahlerup, MD, DrMedSc principal investigator
Aarhus University Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Vitamin D in people with Crohns Disease, run by University of Aarhus at 4 sites in Denmark.
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 3 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: status not confirmed, as of the sponsor's last update on 13 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Denmark. 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.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Relapse rate within 1 year treatment; CDAI>220. 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 13 Apr 2007.