Ulcerative Colitis and Vitamin D Supplementation

NCT01846026 | Withdrawn Phase 1 DMC

• 2 other identifiers: 2009/1392-13 (REK)2009-015649-21
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• change in fecal calprotectin

  12 months after start of intervention

• change in bone mineral density (whole body)

  12 months after the start of intervention

• change in fecal calprotectin

  3 months

• change in tnf-alpha levels in colonic mucosa

  3 months

• change in tnf-alpha (in colonic mucosa)

  12 months after baseline

Study Arms (2)

Vitamin D

EXPERIMENTAL

Decristol (cholecalciferol) 20000 IU per capsule 1 capsule per week

Drug: Vitamin D

Placebo

PLACEBO COMPARATOR

capsule with peanut oil

Drug: placebo

Interventions

Vitamin D DRUG

compare how vitamin D influences the course of ulcerative colitis versus placebo

Also known as: Cholecalciferol

Vitamin D

placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital of North Norway: lead

Study Sites (1)

University Hospital of North Norway

Tromsø, 9014, Norway

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Vitamin D; Cholecalciferol

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholestenes; Cholestanes; Sterols; Membrane Lipids; Lipids

Study Officials

• Elena Kamycheva, MD, PhD

  Medical Clinic, University Hospital of North Norway

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2013
• First Posted: May 3, 2013
• Study Start: April 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: December 1, 2016
• Last Updated: June 2, 2015

Record last verified: 2015-06

Locations

NO (1)