Condition category
Nutritional, Metabolic, Endocrine
Date applied
05/09/2007
Date assigned
05/09/2007
Last edited
18/11/2016
Prospective/Retrospective
Prospectively 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

Dr Dederieke Festen

ORCID ID

Contact details

Dutch Growth Foundation
Westzeedijk 106
Rotterdam
3016 AH
Netherlands
+31 (0)10 225 1533
d.festen@erasmusmc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR1038

Study information

Scientific title

Effects of growth hormone treatment after final height in Prader-Willi Syndrome: a double-blind multicentre, cross-over study on the effects of growth hormone versus placebo on body composition and psychosocial behaviour in transition

Acronym

Study hypothesis

Growth Hormone (GH) treatment after reaching final height is beneficial for body composition and social wellbeing in young adults with Prader-Willi Syndrome (PWS).

Ethics approval

Not provided at time of registration

Study design

Multicentre randomised double-blinded placebo-controlled crossover group trial

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Prader Willi Syndrome

Intervention

Treatment with GH: Genotropin 0.67 mg/m^2/day subcutaneous (s.c.) or placebo.

Intervention type

Drug

Phase

Not Applicable

Drug names

Growth Hormone (GenotropinĀ®)

Primary outcome measures

1. Body composition
2. Carbohydrate metabolism
3. Psychosocial functioning
4. Sleep-related breathing disorders
5. Circulating lipids
6. Blood pressure

Secondary outcome measures

1. Thyroid hormone levels, Insulin-like Growth Factor (IGF-I) and IGF binding proteins, adiponectin, ghrelin
2. Compliance to the diet

Overall trial start date

01/10/2007

Overall trial end date

01/10/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Young adults, originally participating in the Dutch GH study in PWS children (ISRCTN49726762) or otherwise GH-treated patients
2. Final height is reached or epiphysial fusion is complete
3. Treated with GH during childhood for at least two years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

20

Participant exclusion criteria

1. Non-cooperative behaviour
2. Extremely low dietary intake of less than minimal required intake according to World Health Organisation (WHO)
3. Medication to reduce weight (fat)

Recruitment start date

01/10/2007

Recruitment end date

01/10/2011

Locations

Countries of recruitment

Netherlands

Trial participating centre

Dutch Growth Foundation
Rotterdam
3016 AH
Netherlands

Sponsor information

Organisation

Dutch Growth Foundation (Netherlands)

Sponsor details

Westzeedijk 106
Rotterdam
3016 AH
Netherlands

Sponsor type

Research organisation

Website

Funders

Funder type

Industry

Funder name

Pfizer (Netherlands)

Alternative name(s)

Pfizer Inc.

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

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

2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27852283

Publication citations

Additional files

Editorial Notes

18/11/2016: Publication reference added.