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
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
| 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 |
| 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 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 |
| 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 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 20 |
| 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 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
3016 AH
Netherlands
Sponsor information
Dutch Growth Foundation (Netherlands)
Research organisation
Research organisation
Westzeedijk 106
Rotterdam
3016 AH
Netherlands
Funders
Funder type
Industry
Pfizer (Netherlands)
Government organisation / For-profit companies (industry)
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
- Location
- United States of America
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| 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.
