Contact information
Type
Scientific
Contact name
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/CTIS number
IRAS 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(s)
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
Study setting(s)
Not specified
Study 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
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
Overall study end date
01/10/2011
Reason abandoned (if study stopped)
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(s)
Patient
Age group
Adult
Sex
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
Study participating centre
Dutch Growth Foundation
Rotterdam
3016 AH
Netherlands
Funders
Funder type
Industry
Funder name
Pfizer (Netherlands)
Alternative name(s)
Pfizer Inc., Pfizer Consumer Healthcare, Davis
Funding Body Type
government organisation
Funding Body Subtype
For-profit companies (industry)
Location
United States of America
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 16/11/2016 | Yes | No |