Ulcerative Colitis and Vitamin D Supplementation

University Hospital of North Norway

Status and phase: Withdrawn; Phase 2; Phase 1

Conditions: Ulcerative Colitis

Treatments: Drug: placebo; Drug: Vitamin D

Study type: Interventional

Funder types: Other

Identifiers

NCT01846026

2009-015649-21 (EudraCT Number)

2009/1392-13 (REK)

Details and patient eligibility

About

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

Vitamin D

Experimental group

Description:

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

Treatment:

Drug: Vitamin D

Placebo

Placebo Comparator group

Description:

capsule with peanut oil

Treatment:

Drug: placebo