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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

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.

Condition or disease Intervention/treatment Phase
Crohn Disease Drug: prednisolone Dietary Supplement: Alicalm (polymeric liquid formula) Phase 4

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adverse Effects of Glucocorticoid Therapy on Bone in Childhood Crohn's Disease
Study Start Date : February 2008
Estimated Primary Completion Date : January 2010
Estimated Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1 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.
Active Comparator: 2 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.)

Primary Outcome Measures :
  1. Bone mineral density change based on DXA measurement at 1 year [ Time Frame: 12 months post-recruitment ]

Secondary Outcome Measures :
  1. Proportion in remission [ Time Frame: 6 weeks ]
  2. Change in PCDAI, HAB and pHBS [ Time Frame: 6 weeks ]
  3. Quality of life throughout treatment period, using IMPACT III measurements [ Time Frame: 12 months ]
  4. Baseline urine 11B-HSD1 and bone formation [ Time Frame: 6 weeks ]
  5. Baseline urine 11B-HSD1 activity and change in bone mineral density [ Time Frame: 12 months ]
  6. Change in urine 11B-HSD1 activity and PCDAI in patients before and after treatment with LDT and CST [ Time Frame: 12 months ]
  7. Growth impairment [ Time Frame: 12 months ]
  8. Adherence to randomised therapy for relapses [ Time Frame: 12 months ]
  9. Adverse effects [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00609752

Contact: M. Stephen Murphy +44 (0)121 333 8705
Contact: Kelly Spencer +44 (0)121 333 9542

United Kingdom
Royal Liverpool Children's Hospital Recruiting
Liverpool, Merseyside, United Kingdom, L12 2AP
Principal Investigator: Mark Dalzell         
Oxford Children's Hospital Recruiting
Oxford, Oxfordshire, United Kingdom, OX3 9DZ
Principal Investigator: Astor Rodrigues         
Sheffield Children's Hospital Recruiting
Sheffield, South Yorkshire, United Kingdom, S10 2TH
Principal Investigator: Christopher Taylor         
Birmingham Children's Hospital Recruiting
Birmingham, West Midlands, United Kingdom, B4 6NH
Contact: Kelly Spencer    +44 (0)121 333 9542   
Principal Investigator: M Stephen Murphy         
Bristol Royal Hospital for Sick Children Recruiting
Bristol, United Kingdom, BS2 8BJ
Principal Investigator: Christine Spray         
St George's University Hospital Recruiting
London, United Kingdom, SW17 0QT
Principal Investigator: Sally Mitton         
Sponsors and Collaborators
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

Responsible Party: Dr M S Murphy, University of Birmingham Identifier: NCT00609752     History of Changes
Other Study ID Numbers: RG_06_266
EudraCT: 2006-000209-48
CTA: 21761/0213/001
First Posted: February 7, 2008    Key Record Dates
Last Update Posted: December 30, 2008
Last Verified: December 2008

Keywords provided by University Hospital Birmingham:
Crohn Disease
Bone Density
Liquid Diet Therapy
Quality of Life
Metabolic Bone Disease

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents