Effects of growth hormone treatment after final height in Prader-Willi Syndrome
| ISRCTN | ISRCTN24648386 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN24648386 |
| Protocol serial number | NTR1038 |
| Sponsor | Dutch Growth Foundation (Netherlands) |
| Funder | Pfizer (Netherlands) |
- 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
Scientific
Dutch Growth Foundation
Westzeedijk 106
Rotterdam
3016 AH
Netherlands
| Phone | +31 (0)10 225 1533 |
|---|---|
| d.festen@erasmusmc.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre randomised double-blinded placebo-controlled crossover group trial |
| Secondary study design | Randomised cross over trial |
| Study type | 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Growth Hormone (Genotropin®) |
| Primary outcome measure(s) |
1. Body composition |
| Key secondary outcome measure(s) |
1. Thyroid hormone levels, Insulin-like Growth Factor (IGF-I) and IGF binding proteins, adiponectin, ghrelin |
| Completion date | 01/10/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
3016 AH
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 16/11/2016 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
18/11/2016: Publication reference added.
