Ulcerative Colitis and Vitamin D Supplementation

• Register: ClinicalTrials.gov
• Last refreshed on: 29 June 2015
• Main ID: NCT01846026
• Date of registration: 30/04/2013
• Prospective Registration: No
• Primary sponsor: University Hospital of North Norway
• Public title: Ulcerative Colitis and Vitamin D Supplementation
• Scientific title: Immunomodulating and Clinical Effects of Vitamin D on Remission Induction in Patients With Moderate and Severe Ulcerative Colitis, Undergoing Treatment With Infliximab.
• Date of first enrolment: April 2013
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: http://clinicaltrials.gov/show/NCT01846026
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 1/Phase 2

Countries of recruitment

Norway

Contacts

• Name: Elena Kamycheva, MD, PhD
• Affiliation: Medical Clinic, University Hospital of North Norway

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Intervention(s)

Drug: placebo

Drug: Vitamin D

Primary Outcome(s)

number of patients with remission [Time Frame: 12 months after start of intervention]

Secondary Outcome(s)

change in tnf-alpha (in colonic mucosa) [Time Frame: 12 months after baseline]

change in fecal calprotectin [Time Frame: 3 months]

change in tnf-alpha levels in colonic mucosa [Time Frame: 3 months]

change in bone mineral density (whole body) [Time Frame: 12 months after the start of intervention]

change in fecal calprotectin [Time Frame: 12 months after start of intervention]

Secondary ID(s)

2009/1392-13 (REK)

2009-015649-21

Source(s) of Monetary Support

Please refer to primary and secondary sponsors