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Adjuvant Vitamin D With Corticosteroids in Active Crohn's Disease (IBDVit1)

Primary Purpose

Crohn's Disease

Status

Withdrawn

Phase

Phase 4

Locations

United Kingdom

Study Type

Interventional

Intervention

Colecalciferol D3 (Vigantol Oil)

Medium chain triglycerides

About this trial

This is an interventional treatment trial for Crohn's Disease focused on measuring Crohn's Disease, Inflammatory Bowel Disease, Vitamin D, Randomised, Placebo

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Active Crohn's Disease Activity (CDAI) Score >200 to 450;
Diagnosis of IBD and distribution of disease previously confirmed
The participant able to give informed consent form;
Stable doses of the following concurrent IBD medications prior to inclusion:
- 5-aminosalicylates (≥4 weeks)
- Thiopurines (≥8 weeks)
- No corticosteroids (within 4 weeks)
- No biological agents (within 8 weeks).

Exclusion Criteria:

Unable to give informed written consent;
Co-existence of any other chronic inflammatory conditions
Failure to meet concurrent IBD medication criteria;
Hypercalcaemia (Corrected serum calcium > 2.66 mmol/L) or history of vitamin D hypersensitivity;
Diagnosis of any of the flowing: active tuberculosis, sarcoidosis, hyperparathyroidism, pseudohyperparathyroidism, nephrolithiasis, silicosis, liver failure, renal failure or malignancy, active TB, sarcoidosis or lymphoma or other granulomatous disease;
Known intolerance or contraindication to vitamin D or trial medication (i.e. corticosteroids / infliximab);
Biochemical disturbance at enrolment: serum corrected calcium > 2.66 mmol/L) or serum creatinine >250 micromol/L;
Pregnancy or breast-feeding.

Sites / Locations

St. Mark's Hospital
Imperial College Healthcare NHS Trust (Hammersmith, Charing Cross and St. Mary's Hospitals)

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm Description

Standard corticosteroid treatment PLUS Vitamin D3 (Colecalciferol).

Standard corticosteroid treatment PLUS placebo (Migliol Oil)

Outcomes

Primary Outcome Measures

Clinical Remission (CDAI score <150)

Secondary Outcome Measures

Reduction in CDAI suggestive of a clinical improvement.

Reduction in serum C-reactive protein.

Reduction of faecal calprotectin levels

Clinical Remission (CDAI score <150)

Full Information

NCT ID

NCT00672763

First Posted

May 2, 2008

Last Updated

June 3, 2015

Sponsor

Imperial College London

1. Study Identification

Unique Protocol Identification Number

NCT00672763

Brief Title

Adjuvant Vitamin D With Corticosteroids in Active Crohn's Disease

Acronym

IBDVit1

Official Title

The Immunomodulatory Role of Vitamin D in Inflammatory Bowel Disease (The IBDVit Study): Double-Blind, Placebo-Controlled Trial of Adjuvant Vitamin D (Colecalciferol) With Corticosteroids in Active Crohn's Disease

Study Type

Interventional

2. Study Status

Record Verification Date

June 2011

Overall Recruitment Status

Withdrawn

Why Stopped

Unable to recruit adequate trial participants

Study Start Date

May 2008 (undefined)

Primary Completion Date

May 2010 (Anticipated)

Study Completion Date

May 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Imperial College London

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to determine whether the addition of vitamin D to standard corticosteroids improves onset of remission in active Crohn's Disease, a form of Inflammatory Bowel Disease (IBD).

Detailed Description

Crohn's Disease is a form of Inflammatory Bowel Disease (IBD). It is caused by abnormal immune-mediated gut inflammation and is both chronic and difficult to treat. Symptoms are often unpleasant (e.g. abdominal pain, diarrhoea, disfiguring fistulation) and often lead to surgery to remove diseased bowel. There is emerging evidence that Vitamin D, a nutrient largely produced in the skin upon exposure to sun-light, may possess properties regulating the immune system in IBD. In addition, vitamin D deficiency appears common in Inflammatory Bowel Disease. This study aims to determine if the addition of vitamin D to standard corticosteroid treatment in active Crohn's Disease helps to achieve remission (resolution of symptoms).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Crohn's Disease

Keywords

Crohn's Disease, Inflammatory Bowel Disease, Vitamin D, Randomised, Placebo

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Standard corticosteroid treatment PLUS Vitamin D3 (Colecalciferol).

Arm Title

Arm Type

Placebo Comparator

Arm Description

Standard corticosteroid treatment PLUS placebo (Migliol Oil)

Intervention Type

Drug

Intervention Name(s)

Colecalciferol D3 (Vigantol Oil)

Other Intervention Name(s)

CalcichewD3Forte (Calcium and Vitamin D3), Vigantol Oil (Colecalciferol D3)

Intervention Description

Standard oral Prednisolone 40mg daily (or Budesonide 9mg daily) for 4 weeks; Supplemental calcium and vitamin D3 (CalcichewD3Forte) 1000mg and 800iU respectively daily for duration of steroid treatment; Colecalciferol 100,000iU orally once fortnightly for 4 weeks (2 doses).

Intervention Type

Drug

Intervention Name(s)

Medium chain triglycerides

Other Intervention Name(s)

CalcichewD3Forte (Calcium and Vitamin D3), Migliol Oil (Placebo)

Intervention Description

Primary Outcome Measure Information:

Title

Clinical Remission (CDAI score <150)

Time Frame

4 Weeks

Secondary Outcome Measure Information:

Title

Reduction in CDAI suggestive of a clinical improvement.

Time Frame

Week 4

Title

Reduction in serum C-reactive protein.

Time Frame

Week 4

Title

Reduction of faecal calprotectin levels

Time Frame

Week 4

Title

Clinical Remission (CDAI score <150)

Time Frame

Week 6

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Active Crohn's Disease Activity (CDAI) Score >200 to 450; Diagnosis of IBD and distribution of disease previously confirmed The participant able to give informed consent form; Stable doses of the following concurrent IBD medications prior to inclusion: 5-aminosalicylates (≥4 weeks) Thiopurines (≥8 weeks) No corticosteroids (within 4 weeks) No biological agents (within 8 weeks). Exclusion Criteria: Unable to give informed written consent; Co-existence of any other chronic inflammatory conditions Failure to meet concurrent IBD medication criteria; Hypercalcaemia (Corrected serum calcium > 2.66 mmol/L) or history of vitamin D hypersensitivity; Diagnosis of any of the flowing: active tuberculosis, sarcoidosis, hyperparathyroidism, pseudohyperparathyroidism, nephrolithiasis, silicosis, liver failure, renal failure or malignancy, active TB, sarcoidosis or lymphoma or other granulomatous disease; Known intolerance or contraindication to vitamin D or trial medication (i.e. corticosteroids / infliximab); Biochemical disturbance at enrolment: serum corrected calcium > 2.66 mmol/L) or serum creatinine >250 micromol/L; Pregnancy or breast-feeding.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andrew N Milestone, BSc(Hons) MBBS MRCP

Organizational Affiliation

Imperial College London (Hammersmith and St. Mark's Hospitals)

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Subrata Ghosh, MD (Edin) FRCP, FRCP (Edin)

Organizational Affiliation

Imperial College London (Hammersmith Hospital)

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Ailsa L Hart, BA(Hons), BM BCh, MRCP, PhD

Organizational Affiliation

Imperial College London (St. Mark's Hospital)

Official's Role

Study Director

Facility Information:

Facility Name

St. Mark's Hospital

City

Harrow

State/Province

Middlesex

Country

United Kingdom

Facility Name

Imperial College Healthcare NHS Trust (Hammersmith, Charing Cross and St. Mary's Hospitals)

City

London

Country

United Kingdom

12. IPD Sharing Statement

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Adjuvant Vitamin D With Corticosteroids in Active Crohn's Disease

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