Ulcerative Colitis
Conditions
Brief summary
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
Interventions
DRUGVitamin D
compare how vitamin D influences the course of ulcerative colitis versus placebo
DRUGplacebo
Sponsors
University Hospital of North Norway
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| number of patients with remission | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in tnf-alpha (in colonic mucosa) | 12 months after baseline | Biopsies and analysis will be carried out as described ata 3 months follow-up |
| change in fecal calprotectin | 12 months after start of intervention | change in fecal calprotectin compared to baseline value |
| change in bone mineral density (whole body) | 12 months after the start of intervention | change in bone mineral density in whole body, measured with DEXA (t-score and z-score) |
| change in tnf-alpha levels in colonic mucosa | 3 months | 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. |
Countries
Norway
Outcome results
None listed