Condition category
Digestive System
Date applied
23/04/2010
Date assigned
23/04/2010
Last edited
22/07/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Ian Sanderson

ORCID ID

Contact details

Institute of Cell and Molecular Science
Medical College
Turner Street
London
E1 2AD
United Kingdom

Additional identifiers

EudraCT number

2007-004269-16

ClinicalTrials.gov number

Protocol/serial number

4293

Study information

Scientific title

Acronym

IGF in Paed Crohns

Study hypothesis

Growth failure occurs in approximately one third of children with Crohn's disease. Insulin-like growth factor-I (IGF-I) concentrations are depressed in active Crohn's disease, and increase to normal on entering remission with enteral feeding. Growth Hormone concentrations are normal in active disease. The children therefore exhibit a resistance to growth hormones effects.

A proportion of children do not enter remission despite state-of-the-art medications, and some of them continue to fail to grow. Treatment for the growth deficiency caused by low IGF-I activity would offer great benefits in such children.

The treatment for endocrine causes of growth hormone resistance (usually due to growth hormone receptor defects) is subcutaneous IGF-I. Furthermore, injections of human IGF have been shown, in work published from our laboratory, to enhance growth in rats with colitis. An IGF-I preparation is now available to treat children with growth hormone receptor defects, but not other conditions. A detailed understanding of the pharmacokinetics of IGF-I is needed before IGF-I can be considered as a treatment for growth faltering in children with Crohn’s disease. We hypothesized that subcutaneous IGF-I will increase IGF-I concentrations of children with Crohn's disease associated with low IGF-I, without serious adverse effects. To examine this hypothesis we proposed to study three specific aims:
1. To examine the effect of IGF-I on IGF-I and glucose concentrations in the circulation over 24 hours after administration in children with Crohn's disease
2. To examine the effect of daily IGF-I on IGF-I over the course of 1 week
3. To examine the pharmacokinetics of IGF-I in children with documented protein losing enteropathy

Ethics approval

MREC approved on the 19th December 2007 (ref: 07/h0705/77)

Study design

Non-randomised interventional treatment trial

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Topic: Medicines for Children Research Network; Subtopic: All Diagnoses; Disease: All Diseases

Intervention

Increlex subcutaneously; Study Entry : Registration only

Intervention type

Drug

Phase

Not Applicable

Drug names

Recombinant human insulin-like growth factor-I

Primary outcome measures

IGF-I levels

Secondary outcome measures

Blood glucose and hormones of the IGF-I axis

Overall trial start date

25/09/2008

Overall trial end date

01/07/2010

Reason abandoned

Eligibility

Participant inclusion criteria

Criteria for aims 1 and 2:
1. Aged greater than 10 years, either sex
2. Height velocity measured over greater than 6 months: less than -2 SDS
3. Erythrocyte sedimentation rate: greater than 25 mm/hr
4. C-reactive protein: greater than 10 mg/l
5. Albumin greater than 40 g/l
6. Stool alpha-1-antitrypsin concentration: less than 2.0 g/l

Criteria for aim 3:
1. Aged greater than 10 years, either sex
2. Height velocity measured over greater than 6 months: less than -2 SDS
3. Erythrocyte sedimentation rate: greater than 25 mm/hr
4. C-reactive protein: greater than 10 mg/l
5. Albumin less than 35 g/l
6. Stool alpha-1-antitrypsin concentration: greater than 2.3 g/l
7. No corticosteroids for 3 months

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

Planned Sample Size: 10; UK Sample Size: 10

Participant exclusion criteria

1. Neoplasia
2. Fused epiphyses
3. Corticosteroids within last 3 months

Recruitment start date

25/09/2008

Recruitment end date

01/07/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Institute of Cell and Molecular Science
London
E1 2AD
United Kingdom

Sponsor information

Organisation

Queen Mary's School of Medicine and Dentistry (UK)

Sponsor details

Turner Street
London
E1 2AD
United Kingdom

Sponsor type

University/education

Website

http://www.smd.qmul.ac.uk/

Funders

Funder type

Charity

Funder name

Crohn's and Colitis Foundation of America (CCFA) (USA)

Alternative name(s)

Crohn's & Colitis Foundation of America, CCFA

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United States of America

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23793696

Publication citations

  1. Results

    Rao A, Standing JF, Naik S, Savage MO, Sanderson IR, Mathematical modelling to restore circulating IGF-1 concentrations in children with Crohn's disease-induced growth failure: a pharmacokinetic study., BMJ Open, 2013, 3, 5, doi: 10.1136/bmjopen-2013-002737.

Additional files

Editorial Notes