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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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19 December 2016 |
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Main ID: |
ISRCTN24648386 |
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Date of registration:
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05/09/2007 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Effects of growth hormone treatment after final height in Prader-Willi Syndrome
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Scientific title:
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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 |
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Date of first enrolment:
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01/10/2007 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN24648386 |
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Study type:
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Interventional |
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Study design:
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Multicentre randomised double-blinded placebo-controlled crossover group trial (Treatment)
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Phase:
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Not Applicable
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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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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)10 225 1533 |
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Email:
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d.festen@erasmusmc.nl |
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Affiliation:
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Name:
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Affiliation:
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Key inclusion & exclusion criteria
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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
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)
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
Disorders of other endocrine glands
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Intervention(s)
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Treatment with GH: Genotropin 0.67 mg/m^2/day subcutaneous (s.c.) or placebo.
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Primary Outcome(s)
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1. Body composition
2. Carbohydrate metabolism
3. Psychosocial functioning
4. Sleep-related breathing disorders
5. Circulating lipids
6. Blood pressure
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Secondary Outcome(s)
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1. Thyroid hormone levels, Insulin-like Growth Factor (IGF-I) and IGF binding proteins, adiponectin, ghrelin
2. Compliance to the diet
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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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