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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN49726762 |
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Date of registration:
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28/04/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Controlled growth hormone (GH) study in children with Prader-Willi syndrome
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Scientific title:
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Multicentre, randomised, controlled growth hormone study in children with Prader-Willi syndrome: effects on growth, body composition, activity level and psychosocial development |
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Date of first enrolment:
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23/04/2002 |
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Target sample size:
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85 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN49726762 |
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Study type:
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Interventional |
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Study design:
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Multicentre randomised active-controlled parallel group trial (Treatment)
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Phase:
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Dederieke
Festen |
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Address:
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Dutch Growth Foundation
Westzeedijk 106
3016 AH
Rotterdam
Netherlands |
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Telephone:
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+31 (0)10 2251533 |
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Email:
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d.festen@erasmusmc.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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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
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
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Prader-Willi syndrome
Nutritional, Metabolic, Endocrine
Hypofunction and other disorders of pituitary gland
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Intervention(s)
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Treatment with GH: Genotropin® 1 mg/m^2/day subcutaneously (sc) versus no GH-treatment. Dietary and exercise advice.
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Primary Outcome(s)
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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
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Secondary Outcome(s)
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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.
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Source(s) of Monetary Support
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Pfizer (Netherlands)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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