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

NCT ID: NCT00609752

Last Updated: 2008-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2010-01-31

Brief Summary

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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

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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

Conditions

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Crohn Disease

Keywords

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Crohn Disease Children Bone Density Prednisolone Liquid Diet Therapy Quality of Life Metabolic Bone Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type ACTIVE_COMPARATOR

prednisolone

Intervention Type DRUG

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.

2

Group Type ACTIVE_COMPARATOR

Alicalm (polymeric liquid formula)

Intervention Type DIETARY_SUPPLEMENT

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.

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Alicalm (SHS International Ltd.)

Eligibility Criteria

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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
Minimum Eligible Age

7 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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SHS International

UNKNOWN

Sponsor Role collaborator

Children's Memorial Research Foundation

UNKNOWN

Sponsor Role collaborator

St George's University Hospital Research Foundation

UNKNOWN

Sponsor Role collaborator

University Hospital Birmingham

OTHER

Sponsor Role lead

Responsible Party

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University of Birmingham

Principal Investigators

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M. Stephen Murphy

Role: STUDY_DIRECTOR

University of Birmingham

Locations

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Bristol Royal Hospital for Sick Children

Bristol, Bristol, United Kingdom

Site Status RECRUITING

St George's University Hospital

London, London, United Kingdom

Site Status RECRUITING

Royal Liverpool Children's Hospital

Liverpool, Merseyside, United Kingdom

Site Status RECRUITING

Oxford Children's Hospital

Oxford, Oxfordshire, United Kingdom

Site Status RECRUITING

Sheffield Children's Hospital

Sheffield, South Yorkshire, United Kingdom

Site Status RECRUITING

Birmingham Children's Hospital

Birmingham, West Midlands, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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M. Stephen Murphy

Role: CONTACT

Phone: +44 (0)121 333 8705

Email: [email protected]

Kelly Spencer

Role: CONTACT

Phone: +44 (0)121 333 9542

Email: [email protected]

Facility Contacts

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Kelly Spencer

Role: primary

Other Identifiers

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EudraCT: 2006-000209-48

Identifier Type: -

Identifier Source: secondary_id

CTA: 21761/0213/001

Identifier Type: -

Identifier Source: secondary_id

RG_06_266

Identifier Type: -

Identifier Source: org_study_id