null - FindTrial

Trial of Adjuvant Vitamin D with Standard Maintenance Therapy in Preventing Relapse of Inflammatory Bowel Disease - IBDVit3

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-001467-10-GB

Enrollment

120

Registered

2008-03-28

Start date

2008-04-30

Completion date

Unknown

Last updated

2012-07-24

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

Conditions

Ulcerative colitis - in remission Crohn's Disease - in remission MedDRA version: 9.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis MedDRA version: 9.1 Level: LLT Classification code 10011401 Term: Crohn's disease

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients must be in clinical remission based on a Crohn’s Disease Activity (CDAI) Score =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 in the inclusion criteria; 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 following: active tuberculosis, sarcoidosis, hyperparathyroidism, pseudohyperparathyroidism, 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; 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: To demonstrate the efficacy of adjuvant Vitamin D with standard maintenance therapy in preventing relapse of Inflammatory Bowel Disease in remission. ;Secondary Objective: Demonstrate the efficacy of vitamin D with standard maintenance therapy to: - reduce the number of clinical relapses; - reduce cumulative steroid dosage; - limit escalation of maintenance therapy.;Primary end point(s): Primary Efficacy Endpoint: Maintenance of clinical remission at 26 weeks, defined as no requirement for systemic steroids or infliximab during this period.	—

Measure

Time frame

Main Objective: To demonstrate the efficacy of adjuvant Vitamin D with standard maintenance therapy in preventing relapse of Inflammatory Bowel Disease in remission. ;Secondary Objective: Demonstrate the efficacy of vitamin D with standard maintenance therapy to: - reduce the number of clinical relapses; - reduce cumulative steroid dosage; - limit escalation of maintenance therapy.;Primary end point(s): Primary Efficacy Endpoint: 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