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

NCT00609752 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2008-12-30

No results posted yet for this study

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.

Conditions

  • Crohn Disease

Interventions

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.

Sponsors & Collaborators

  • SHS International

    collaborator UNKNOWN

  • Children's Memorial Research Foundation

    collaborator UNKNOWN

  • St George's University Hospital Research Foundation

    collaborator UNKNOWN

  • University Hospital Birmingham

    lead OTHER

Principal Investigators

  • M. Stephen Murphy · University of Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2010-01-31
Completion
2010-01-31

Countries

  • United Kingdom

Study Locations

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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 NCT00609752 on ClinicalTrials.gov