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Controlled growth hormone (GH) study in children with Prader-Willi syndrome
ISRCTN ISRCTN49726762
DOI 10.1186/ISRCTN49726762
ClinicalTrials.gov identifier
EudraCT number
Public title Controlled growth hormone (GH) study in children with Prader-Willi syndrome
Scientific title Multicentre, randomised, controlled growth hormone study in children with Prader-Willi syndrome: effects on growth, body composition, activity level and psychosocial development
Acronym N/A
Serial number at source NTR628
Study hypothesis 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.
Lay summary Not provided at time of registration
Ethics approval Local medical ethics committee gave approval
Study design Multicentre randomised active-controlled parallel group trial
Countries of recruitment Netherlands
Disease/condition/study domain Prader-Willi syndrome
Participants - 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
Participants - 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
Anticipated start date 23/04/2002
Anticipated end date 01/05/2007
Status of trial Completed
Patient information material
Target number of participants 85
Interventions Treatment with GH: Genotropin® 1 mg/m^2/day subcutaneously (sc) versus no GH-treatment. Dietary and exercise advice.
Primary outcome measure(s) To asses effects of GH-treatment versus no GH-treatment in children with Prader-Willi syndrome on:
1. Height, weight, body composition, muscle mass, muscle strength and daily life activity
2. Cognition, behaviour and social emotional development
3. Resting energy expenditure
4. Psychomotor development in infants
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.
Sources of funding Pfizer (Netherlands)
Trial website
Publications 1. 2009 results on effect of GH-treatment on incidence of scoliosis in http://www.ncbi.nlm.nih.gov/pubmed/19158197
2. 2009 results on effect of GH-treatment on bone density in http://www.ncbi.nlm.nih.gov/pubmed/19622627
3. 2012 ovarian function results in http://www.ncbi.nlm.nih.gov/pubmed/22723315
Contact name Dr  Dederieke  Festen
  Address Dutch Growth Foundation
Westzeedijk 106
  City/town Rotterdam
  Zip/Postcode 3016 AH
  Country Netherlands
  Tel +31 (0)10 2251533
  Fax +31 (0)10 2250133
  Email d.festen@erasmusmc.nl
Sponsor Dutch Growth Foundation (Netherlands)
  Address Westzeedijk 106
  City/town Rotterdam
  Zip/Postcode 3016 AH
  Country Netherlands
Date applied 28/04/2006
Last edited 05/11/2012
Date ISRCTN assigned 28/04/2006
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