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Adverse Effects of Glucocorticoid Therapy on Bone in Childhood Crohn's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00609752
Recruitment Status : Unknown
Verified December 2008 by University Hospital Birmingham.
Recruitment status was:  Recruiting
First Posted : February 7, 2008
Last Update Posted : December 30, 2008
SHS International
Children's Memorial Research Foundation
St George's University Hospital Research Foundation
Information provided by:
University Hospital Birmingham

Tracking Information
First Submitted Date  ICMJE January 24, 2008
First Posted Date  ICMJE February 7, 2008
Last Update Posted Date December 30, 2008
Study Start Date  ICMJE February 2008
Estimated Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 24, 2008)
Bone mineral density change based on DXA measurement at 1 year [ Time Frame: 12 months post-recruitment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 24, 2008)
  • Proportion in remission [ Time Frame: 6 weeks ]
  • Change in PCDAI, HAB and pHBS [ Time Frame: 6 weeks ]
  • Quality of life throughout treatment period, using IMPACT III measurements [ Time Frame: 12 months ]
  • Baseline urine 11B-HSD1 and bone formation [ Time Frame: 6 weeks ]
  • Baseline urine 11B-HSD1 activity and change in bone mineral density [ Time Frame: 12 months ]
  • Change in urine 11B-HSD1 activity and PCDAI in patients before and after treatment with LDT and CST [ Time Frame: 12 months ]
  • Growth impairment [ Time Frame: 12 months ]
  • Adherence to randomised therapy for relapses [ Time Frame: 12 months ]
  • Adverse effects [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Adverse Effects of Glucocorticoid Therapy on Bone in Childhood Crohn's Disease
Official Title  ICMJE Adverse Effects of Glucocorticoid Therapy on Bone in Childhood Crohn's Disease
Brief Summary This study will compare two current first-line treatments for childhood Crohn's Disease, steroids versus a liquid diet, and determine the effects of these treatments on bone health, quality of life and treatment efficacy.
Detailed Description

Crohn's Disease is a very serious inflammatory gut disorder that often first presents in childhood. Once present, the underlying condition remains for life. It usually responds well to medical treatment which brings about a disease 'remission' but is inclined to become active again at intervals (relapses). When it is active, children are very unwell with reduced energy, loss of appetite and distressing abdominal symptoms (pain, diarrhea, etc.). Active disease can be treated in two very different ways - either with a 3-month course of steroids (tablets), or with a 6-week course of so called "liquid diet therapy (LDT)." With LDT, children receive all of their nutrition in liquid form. Both treatments have advantages and disadvantages. Both are quite effective, often controlling symptoms within days. Steroids may cause various side effects including thinning of bones (osteoporosis) with increased risk of fractures. LDT is somewhat challenging because normal (solid) foods are not allowed during the period of treatment. Both steroids and LDT are widely used - steroids predominately in the USA and LDT elsewhere. There is controversy as to which is best. This study aims to determine which should be preferred.

In this clinical study, children presenting with Crohn's disease will be randomly assigned to either steroid treatment or LDT and followed up for a period of one year. During that time the assigned treatment will be used for any episodes of active disease. We will study a total of 80 children attending the Paediatric Gastroenterology Units in Birmingham, Bristol, Liverpool, Oxford, Sheffield and St. George's Hospital in London. Various outcomes will be compared in the two groups. We will examine the recovery rates (success in bringing about remission) and the frequency of subsequent relapses. We will compare growth and physical development, because active Crohn's disease and possibly steroids may have adverse effects on these processes. A special focus of the study will be on the effect of the disease and its treatment on bone health. Using special blood and urine tests and bone scans we will compare bone growth and density in the two groups. Finally, it is crucially important that we consider the impact of the disease and its treatment on the young person on the basis of their own individual perspective. To do this we will compare the 'quality of life' of children in the two treatment groups, using a questionnaire specially designed to measure this aspect in young people with Crohn's disease.

This study will thus enable us to undertake a comprehensive comparison of the two major first-line treatments used in childhood Crohn's Disease. This is crucially important, and no such study has previously been undertaken

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Crohn Disease
Intervention  ICMJE
  • Drug: prednisolone
    Standard treatment regimens based on body weight will be used (approximately 2 mg per kg), with a stepwise dose reduction over a 10-14 week period.
  • Dietary Supplement: Alicalm (polymeric liquid formula)
    Subjects will receive all of their nutritional requirements in the form of a nutritionally balanced polymeric feed, volume based on EAR for age. Duration of 5 to 8 weeks with subjects returning to a "normal" unrestricted diet by 10 weeks.
    Other Name: Alicalm (SHS International Ltd.)
Study Arms  ICMJE
  • Active Comparator: 1
    Intervention: Drug: prednisolone
  • Active Comparator: 2
    Intervention: Dietary Supplement: Alicalm (polymeric liquid formula)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 24, 2008)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2010
Estimated Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Active Crohn's Disease with PCDAI > 20
  • Aged 7 - 17 with possibility of 1 year follow-up

Exclusion Criteria:

  • Previous treatment for Crohn's Disease with liquid diet or glucocorticoid therapy
  • Isolated orofacial granulomatosis
  • Intravenous glucocorticoid therapy immediately indicated
  • Planned surgical intervention for CD
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 7 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00609752
Other Study ID Numbers  ICMJE RG_06_266
EudraCT: 2006-000209-48
CTA: 21761/0213/001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr M S Murphy, University of Birmingham
Study Sponsor  ICMJE University Hospital Birmingham
Collaborators  ICMJE
  • SHS International
  • Children's Memorial Research Foundation
  • St George's University Hospital Research Foundation
Investigators  ICMJE
Study Director: M. Stephen Murphy University of Birmingham
PRS Account University Hospital Birmingham
Verification Date December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP