Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2009-015649-21 | EudraCT Number |
Not provided
Not provided
Not provided
At the planned study start new treatment guidelines for this disease with new drugs were implemented in clinical practice.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D | Experimental | Decristol (cholecalciferol) 20000 IU per capsule 1 capsule per week |
|
| Placebo | Placebo Comparator | capsule with peanut oil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D | Drug | compare how vitamin D influences the course of ulcerative colitis versus placebo |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 months after start of intervention |
| Measure | Description | Time Frame |
|---|---|---|
| change in fecal calprotectin | change in fecal calprotectin compared to baseline value | 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Elena Kamycheva, MD, PhD | Medical Clinic, University Hospital of North Norway | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of North Norway | Tromsø | 9014 | Norway |
Not provided
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D014807 | Vitamin D |
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| placebo | Drug |
|
| 12 months after the start of intervention |
| change in fecal calprotectin | change in fecal calprotectin | 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. | 3 months |
| change in tnf-alpha (in colonic mucosa) | Biopsies and analysis will be carried out as described ata 3 months follow-up | 12 months after baseline |
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D002782 |
| Cholestenes |
| D002776 | Cholestanes |
| D013261 | Sterols |
| D008563 | Membrane Lipids |
| D008055 | Lipids |