The Immunomodulatory Role of Vitamin D in Inflammatory Bowel Disease (IBDVit): IBDVit1 - Trial of Adjuvant Vitamin D with Corticosteroids in Active Crohn’s Disease; IBDVit2 - Trial of Adjuvant Vitamin D with Infliximab in Active Crohn's Disease; IBDVit3 - Trial of Adjuvant Vitamin D with standard maintenance therapy in preventing relapse of Inflammatory Bowel Disease. - IBDVit

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-006692-37-GB

Enrollment

210

Registered

2008-01-25

Start date

2008-04-10

Completion date

Unknown

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IBDVit1 - Active Crohn's Disease IBDVit2 - Active Crohn's Disease IBDVit3 - Crohn's Disease in remission / Ulcerative Colitis in remission MedDRA version: 9.1 Level: LLT Classification code 10011401 Term: Crohn's disease MedDRA version: 9.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis

Interventions

Trade Name: Vigantol Oel Product Name: Vigantol Oel TM Pharmaceutical Form: Oral liquid Pharmaceutical form of the placebo: Oral liquid

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: IBDVit1/IBDVit2: 1) Age 18 year or older. 2) Active Crohn’s Disease Activity (CDAI) Score >200 to 450. 2) The diagnosis of IBD and distribution of disease will have been confirmed during the course of their diagnostic investigations including endoscopic and histological parameters compatible with this diagnosis. 3) The participant must be able to fully understand patient information sheet and sign an informed consent form 4) Patients will be on a stable dose of the following medications prior to inclusion - 5-aminosalicylates (=4 weeks) - Thiopurines (=8 weeks). - No corticosteroids (=4 weeks) - No biological agents (=8 weeks) IBDVit3:- As IBDVit 1 and 2 plus; 1) Remission in Crohn's Disease (CDAI =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1) Patients unable to give informed written consent; 2) Co-existence of any other chronic inflammatory condition e.g. rheumatoid arthritis; 3) Failure to meet above inclusion criteria medication regime as described above; 4) Hypercalcaemia (Corrected serum calcium > 2.66 mmol/L) or history of vitamin D hypersensitivity (e.g. Primary hyperparathyroidism); 5) Diagnosis of any of the flowing: active tuberculosis, sarcoidosis, hyperparathyroidism, nephrolithiasis, silicosis, liver failure, renal failure or malignancy,active TB, sarcoidosis or lymphoma or other granbulomatous disease; 6) Known intolerance or contraindication to vitamin D or trial medication (i.e. corticosteroids / infliximab); 7) Biochemical disturbance at enrolment: serum corrected calcium > 2.66 mmol/L) or serum creatinine >250 micromol/L; 8) Pregnancy or breast-feeding.

Design outcomes

Primary

Measure	Time frame
Main Objective: IBDVit1 - Demonstrate efficacy of colecalciferol (Vitamin D) as an adjuvant treatment to corticosteroids in the induction of clinical remission in active Crohn’s Disease. IBDVit2 - Demonstrate efficacy of colecalciferol (Vitamin D) as an adjuvant treatment to Infliximab in the induction of clinical remission in active Crohn’s Disease. IBDVit3 - Demonstrate efficacy of colecalciferol (Vitamin D) as an adjuvant treatment to standard maintenance therapy in preventing the relapse in Inflammatory Bowel Disease. ; Secondary Objective: Secondary research objectives include: 1) Demonstration of the ability of vitamin D to improve symptoms in active Crohn's Disease; 2) Demonstration of the ability of vitamin D to reduce the overall use of steroids and escalation of standard maintenance theapy in relapsing patients. ; Primary end point(s): IBDVit1 - Clinical Remission at end of week 4 based on CDAI score <150. IBDVit2 - Clinical Remission at end of week 8 based on CDAI score <150. IBDVit3 - Maintenance of clinical remission at 26 weeks, defined as no requirement for systemic steroids or infliximab during this period.	—

Measure

Time frame

Main Objective: IBDVit1 - Demonstrate efficacy of colecalciferol (Vitamin D) as an adjuvant treatment to corticosteroids in the induction of clinical remission in active Crohn’s Disease. IBDVit2 - Demonstrate efficacy of colecalciferol (Vitamin D) as an adjuvant treatment to Infliximab in the induction of clinical remission in active Crohn’s Disease. IBDVit3 - Demonstrate efficacy of colecalciferol (Vitamin D) as an adjuvant treatment to standard maintenance therapy in preventing the relapse in Inflammatory Bowel Disease. ; Secondary Objective: Secondary research objectives include: 1) Demonstration of the ability of vitamin D to improve symptoms in active Crohn's Disease; 2) Demonstration of the ability of vitamin D to reduce the overall use of steroids and escalation of standard maintenance theapy in relapsing patients. ; Primary end point(s): IBDVit1 - Clinical Remission at end of week 4 based on CDAI score <150. IBDVit2 - Clinical Remission at end of week 8 based on CDAI score <150. IBDVit3 - Maintenance of clinical remission at 26 weeks, defined as no requirement for systemic steroids or infliximab during this period.

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026