Ulcerative ColitisPhase 1/2NCT01846026
Ulcerative Colitis and Vitamin D Supplementation
A Phase 1/2 study testing Vitamin D in people with Ulcerative Colitis, run by University Hospital of North Norway at 1 site in Norway.
Trial summary
Ulcerative colitis (UC) is an inflammatory disease involving the colonic mucosa, with bleedings and ulcerations. Consequences are destroyed mucosal barrier and increased permeability. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis
- 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
- 0 participants
- Where
- 1 siteNorway
- Study dates
- Apr 2013to Dec 2016
- Phase
- Phase 1/2
- 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
- Men and women older than18 years old, diagnosed with UC (either debut or relapsed chronic UC), moderate or severe, where it is an indication to treat with infliximab.
Who cannot join
- Primary hyperparathyroidism (PHPT)
- Sarcoidosis
- Renal failure (serum creatinine > 125 mumol/L in men or > 105 mumol/L in women)
- Those, who use solarium routinely are not included
- Pregnant or breastfeeding women, otherwise women of fertile age must be on approved birth control methods during the study
- Renal stones last 15 years
- Cancer of any origin, diagnosed during last 5 years
- Unstable angina pectoris
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immunomodulating and Clinical Effects of Vitamin D on Remission Induction in Patients With Moderate and Severe Ulcerative Colitis, Undergoing Treatment With Infliximab.
Ulcerative colitis (UC) is an inflammatory disease involving the colonic mucosa, with bleedings and ulcerations. Consequences are destroyed mucosal barrier and increased permeability. Several cytokines are described to mediate the progressive course of ulcerative colitis and it is considered nowadays an immunologic disease. Patients with UC have often low levels of vitamin D and elevated prevalence of osteoporosis.
In vitro studies demonstrate that vitamin D has an immunomodulating effect, and may have a direct healing action on colonic mucosa has been described in animal studies. One can therefore rise a hypothesis that vitamin D supplementation could be crucial in patients with UC. To our knowledge, it has not been performed randomized clinical trials to study these possible effects of vitamin D and it has not been studied the effects of vitamin D on the relapse frequency and immunological composition of colic mucosa in patient with moderate to severe ulcerative colitis.
Read more
Objectives for our study are as follows: To examine if high-dose vitamin D supplementation in patients with moderate to severe ulcerative colitis:
- reduces relapse frequency and increase the duration of the Infliximab induced remission
- mediates and changes the cytokines composition in the colic mucosa
- decreases the excretion of calprotectin in feces and reduces the concentration of inflammation markers
- augments bone mass
- Conditions
- Ulcerative Colitis
- Being tested
- Vitamin D, placebo
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDrug
Also called Cholecalciferol
compare how vitamin D influences the course of ulcerative colitis versus placebo
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D | Experimental | Decristol (cholecalciferol) 20000 IU per capsule
1 capsule per week Receives: Drug: Vitamin D |
| Placebo | Placebo comparator | capsule with peanut oil Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients with remission
Mandatory criterion of remission: clinical remission (defined as Mayo score <= 1, including endoscopic findings) and non-mandatory: laboratory (calprotectin < 100, WBC and SR within reference range). These criteria will be assessed at 12 month after the start of intervention
Measured: 12 months after start of intervention
Secondary outcomes (5)
change in fecal calprotectin
change in fecal calprotectin compared to baseline value
Measured: 12 months after start of intervention
change in bone mineral density (whole body)
change in bone mineral density in whole body, measured with DEXA (t-score and z-score)
Measured: 12 months after the start of intervention
change in fecal calprotectin
change in fecal calprotectin
Measured: 3 months
change in tnf-alpha levels in colonic mucosa
change in mucosal tnf-alpha levels. Biopsies will be taken with the forceps from the colonic mucosa (colon sigmoid) and stored in RNA later media for the further analysis for TNF alpha concentration with PCR method.
Measured: 3 months
change in tnf-alpha (in colonic mucosa)
Biopsies and analysis will be carried out as described ata 3 months follow-up
Measured: 12 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2013 (estimated)
- Study startApr 2013
- Primary completionApr 2014
- Study completionDec 2016 (estimated)
Why it stopped: At the planned study start new treatment guidelines for this disease with new drugs were implemented in clinical practice.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies 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 1/2
- 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
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elena Kamycheva, MD, PhD, Principal investigator, Medical Clinic, University Hospital of North Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01846026
- Sponsor's protocol ID
- 2009/1392-13 (REK)
- Other IDs
- 2009-015649-21, 2009
- Status last verified
- Jun 2015
- First submitted
- 30 Apr 2013
- Last updated
- 2 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunomodulating and Clinical Effects of Vitamin D on Remission Induction in Patients With Moderate and Severe Ulcerative Colitis, Undergoing Treatment With Infliximab.
- ClinicalTrials.gov ID
- NCT01846026
- Acronym / sponsor ID
- 2009/1392-13 (REK)
- Conditions
- Ulcerative Colitis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: At the planned study start new treatment guidelines for this disease with new drugs were implemented in clinical practice.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Dec 2016 (estimated)
- First posted
- 3 May 2013 (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.
Ulcerative colitis (UC) is an inflammatory disease involving the colonic mucosa, with bleedings and ulcerations. Consequences are destroyed mucosal barrier and increased permeability. Several cytokines are described to mediate the progressive course of ulcerative colitis and it is considered nowadays an immunologic disease. Patients with UC have often low levels of vitamin D and elevated prevalence of osteoporosis.
In vitro studies demonstrate that vitamin D has an immunomodulating effect, and may have a direct healing action on colonic mucosa has been described in animal studies. One can therefore rise a hypothesis that vitamin D supplementation could be crucial in patients with UC. To our knowledge, it has not been performed randomized clinical trials to study these possible effects of vitamin D and it has not been studied the effects of vitamin D on the relapse frequency and immunological composition of colic mucosa in patient with moderate to severe ulcerative colitis.
Objectives for our study are as follows: To examine if high-dose vitamin D supplementation in patients with moderate to severe ulcerative colitis:
- reduces relapse frequency and increase the duration of the Infliximab induced remission
- mediates and changes the cytokines composition in the colic mucosa
- decreases the excretion of calprotectin in feces and reduces the concentration of inflammation markers
- augments bone mass
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 |
|---|---|---|
| Vitamin D | Experimental | Drug: Vitamin DDecristol (cholecalciferol) 20000 IU per capsule 1 capsule per week |
| Placebo | Placebo comparator | Drug: placebocapsule with peanut oil |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men and women older than18 years old, diagnosed with UC (either debut or relapsed chronic UC), moderate or severe, where it is an indication to treat with infliximab.
Key exclusion criteria (8 listed)
- Primary hyperparathyroidism (PHPT)
- Sarcoidosis
- Renal failure (serum creatinine > 125 mumol/L in men or > 105 mumol/L in women)
- Those, who use solarium routinely are not included
- Pregnant or breastfeeding women, otherwise women of fertile age must be on approved birth control methods during the study
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: Cholecalciferolcompare how vitamin D influences the course of ulcerative colitis versus placebo | Drug | Vitamin D |
| placebo | Drug | Placebo |
Primary outcome
number of patients with remission
Time frame: 12 months after start of intervention
Mandatory criterion of remission: clinical remission (defined as Mayo score <= 1, including endoscopic findings) and non-mandatory: laboratory (calprotectin < 100, WBC and SR within reference range). These criteria will be assessed at 12 month after the start of intervention
5 secondary outcomes
change in fecal calprotectin
Time frame: 12 months after start of intervention
change in bone mineral density (whole body)
Time frame: 12 months after the start of intervention
change in fecal calprotectin
Time frame: 3 months
change in tnf-alpha levels in colonic mucosa
Time frame: 3 months
change in tnf-alpha (in colonic mucosa)
Time frame: 12 months after baseline
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 2 Jun 2015.
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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.
Elena Kamycheva, MD, PhD principal investigator
Medical Clinic, University Hospital of North Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Vitamin D in people with Ulcerative Colitis, run by University Hospital of North Norway at 1 site in Norway.
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 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 2 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 1 site in Norway. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
number of patients with remission (time frame: 12 months after start of intervention). 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 2 Jun 2015.