Controlled growth hormone (GH) study in children with Prader-Willi syndrome
| ISRCTN | ISRCTN49726762 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN49726762 |
| Protocol serial number | NTR628 |
| Sponsor | Dutch Growth Foundation (Netherlands) |
| Funder | Pfizer (Netherlands) |
- Submission date
- 28/04/2006
- Registration date
- 28/04/2006
- Last edited
- 05/11/2012
- 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 2251533 |
|---|---|
| d.festen@erasmusmc.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre randomised active-controlled parallel group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Multicentre, randomised, controlled growth hormone study in children with Prader-Willi syndrome: effects on growth, body composition, activity level and psychosocial development |
| Study objectives | Growth hormone (GH) treatment improves height, weight, body composition, muscle strength, activity level, psychosocial development, psychomotor development in infants, metabolism and respiratory function versus no GH treatment in children with Prader-Willi syndrome. |
| Ethics approval(s) | Local medical ethics committee gave approval |
| Health condition(s) or problem(s) studied | Prader-Willi syndrome |
| Intervention | Treatment with GH: Genotropin® 1 mg/m^2/day subcutaneously (sc) versus no GH-treatment. Dietary and exercise advice. |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Genotropin® |
| Primary outcome measure(s) |
To asses effects of GH-treatment versus no GH-treatment in children with Prader-Willi syndrome on: |
| Key secondary outcome measure(s) |
To study the effect of additional dietary advice and physical exercise on body composition in children with Prader-Willi syndrome treated with GH versus not treated with GH. |
| Completion date | 01/05/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Months |
| Upper age limit | 16 Years |
| Sex | All |
| Target sample size at registration | 85 |
| Key inclusion criteria | 1. Genetically confirmed diagnosis of Prader-Willi syndrome 2. Age between 6 months and 16 years at start of the study 3. Bone age less than 16 years |
| Key exclusion criteria | 1. Extremely low dietary intake 2. Severe scoliosis (consult spinal surgeon) 3. Body mass index (BMI) SDS greater than +3 4. In children greater than 3 years, height SDS less than 0 unless weight for height greater than +2SDS |
| Date of first enrolment | 23/04/2002 |
| Date of final enrolment | 01/05/2007 |
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 on effect of GH-treatment on incidence of scoliosis | 01/04/2009 | Yes | No | |
| Results article | results on effect of GH-treatment on bone density | 01/10/2009 | Yes | No | |
| Results article | ovarian function results | 01/09/2012 | Yes | No |
