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Adjuvant Vitamin D With Corticosteroids in Active Crohn's Disease

NCT00672763 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2015-06-08

No results posted yet for this study

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

Interventions

DRUG

Colecalciferol D3 (Vigantol Oil)

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).

DRUG

Medium chain triglycerides

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)

Sponsors & Collaborators

  • Imperial College London

    lead OTHER

Principal Investigators

  • Andrew N Milestone, BSc(Hons) MBBS MRCP · Imperial College London (Hammersmith and St. Mark's Hospitals)

  • Subrata Ghosh, MD (Edin) FRCP, FRCP (Edin) · Imperial College London (Hammersmith Hospital)

  • Ailsa L Hart, BA(Hons), BM BCh, MRCP, PhD · Imperial College London (St. Mark's Hospital)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2010-05-31
Completion
2010-05-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00672763 on ClinicalTrials.gov