Effects of growth hormone treatment after final height in Prader-Willi Syndrome

ISRCTN	ISRCTN24648386
DOI	https://doi.org/10.1186/ISRCTN24648386
Secondary identifying numbers	NTR1038

Submission date: 05/09/2007
Registration date: 05/09/2007
Last edited: 18/11/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Dederieke Festen
Scientific

Dutch Growth Foundation
Westzeedijk 106
Rotterdam
3016 AH
Netherlands

Phone	+31 (0)10 225 1533
Email	d.festen@erasmusmc.nl

Study information

Study design	Multicentre randomised double-blinded placebo-controlled crossover group trial
Primary study design	Interventional
Secondary study design	Randomised cross over trial
Study setting(s)
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet
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
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Prader Willi Syndrome
Intervention	Treatment with GH: Genotropin 0.67 mg/m^2/day subcutaneous (s.c.) or placebo.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Growth Hormone (Genotropin®)
Primary outcome measure	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 study start date	01/10/2007
Completion date	01/10/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target number of participants	20
Key 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
Key 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)
Date of first enrolment	01/10/2007
Date of final enrolment	01/10/2011

Locations

Countries of recruitment

Netherlands

Study participating centre

Dutch Growth Foundation

Rotterdam
3016 AH
Netherlands

Sponsor information

Funders

Funder type

Industry

Pfizer (Netherlands)
Government organisation / For-profit companies (industry)

Alternative name(s): Pfizer Inc., Pfizer Consumer Healthcare, Davis, Charles Pfizer & Company, Warner-Lambert, King Pharmaceuticals, Wyeth Pharmaceuticals, Seagen, Pfizer Inc
Location: United States of America

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	16/11/2016		Yes	No

Editorial Notes

18/11/2016: Publication reference added.