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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2008 by University Hospital Birmingham.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00609752
First Posted: February 7, 2008
Last Update Posted: December 30, 2008
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.
Collaborators:
SHS International
Children's Memorial Research Foundation
St George's University Hospital Research Foundation
Information provided by:
University Hospital Birmingham
January 24, 2008
February 7, 2008
December 30, 2008
February 2008
January 2010   (Final data collection date for primary outcome measure)
Bone mineral density change based on DXA measurement at 1 year [ Time Frame: 12 months post-recruitment ]
Same as current
Complete list of historical versions of study NCT00609752 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Adverse Effects of Glucocorticoid Therapy on Bone in Childhood Crohn's Disease
Adverse Effects of Glucocorticoid Therapy on Bone in Childhood Crohn's Disease
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.

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

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Crohn Disease
  • 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.)
  • Active Comparator: 1
    Intervention: Drug: prednisolone
  • Active Comparator: 2
    Intervention: Dietary Supplement: Alicalm (polymeric liquid formula)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
80
January 2010
January 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
7 Years to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT00609752
RG_06_266
EudraCT: 2006-000209-48
CTA: 21761/0213/001
Yes
Not Provided
Not Provided
Dr M S Murphy, University of Birmingham
University Hospital Birmingham
  • SHS International
  • Children's Memorial Research Foundation
  • St George's University Hospital Research Foundation
Study Director: M. Stephen Murphy University of Birmingham
University Hospital Birmingham
December 2008

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