Adjuvant Vitamin D With Corticosteroids in Active Crohn's Disease

NCT00672763 | Withdrawn Phase 4 DMC

• 2 other identifiers: VITDIBD1EudraCT: 2007-006692-37
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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).

Conditions

Crohn's Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Clinical Remission (CDAI score <150)

  4 Weeks

Secondary Outcomes (4)

• Reduction in CDAI suggestive of a clinical improvement.

  Week 4

• Reduction in serum C-reactive protein.

  Week 4

• Reduction of faecal calprotectin levels

  Week 4

• Clinical Remission (CDAI score <150)

  Week 6

Study Arms (2)

A

ACTIVE COMPARATOR

Standard corticosteroid treatment PLUS Vitamin D3 (Colecalciferol).

Drug: Colecalciferol D3 (Vigantol Oil)

B

PLACEBO COMPARATOR

Standard corticosteroid treatment PLUS placebo (Migliol Oil)

Drug: Medium chain triglycerides

Interventions

Colecalciferol D3 (Vigantol Oil) DRUG

1. Standard oral Prednisolone 40mg daily (or Budesonide 9mg daily) for 4 weeks; 2. Supplemental calcium and vitamin D3 (CalcichewD3Forte) 1000mg and 800iU respectively daily for duration of steroid treatment; 3. Colecalciferol 100,000iU orally once fortnightly for 4 weeks (2 doses).

Also known as: CalcichewD3Forte (Calcium and Vitamin D3), Vigantol Oil (Colecalciferol D3)

A

Medium chain triglycerides DRUG

1. Standard oral Prednisolone 40mg daily (or Budesonide 9mg daily) for 4 weeks; 2. Supplemental calcium and vitamin D3 (CalcichewD3Forte) 1000mg and 800iU respectively daily for duration of steroid treatment; 3. Migliol Oil 5ml oral fortnightly (2 doses)

Also known as: CalcichewD3Forte (Calcium and Vitamin D3), Migliol Oil (Placebo)

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• aminosalicylates (≥4 weeks)
• Thiopurines (≥8 weeks)
• No corticosteroids (within 4 weeks)
• No biological agents (within 8 weeks).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (2)

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

London, London, United Kingdom

Location

St. Mark's Hospital

Harrow, Middlesex, United Kingdom

Location

MeSH Terms

Conditions

Crohn Disease; Inflammatory Bowel Diseases

Interventions

Calcium; Cholecalciferol

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals; Blood Coagulation Factors; Biological Factors; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Andrew N Milestone, BSc(Hons) MBBS MRCP

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

  PRINCIPAL INVESTIGATOR

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

  Imperial College London (Hammersmith Hospital)

  STUDY CHAIR

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

  Imperial College London (St. Mark's Hospital)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 2, 2008
• First Posted: May 6, 2008
• Study Start: May 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: June 8, 2015

Record last verified: 2011-06

Locations

GB (2)