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Intranasal administration of oxytocin in PWS


- candidate number21381
- NTR NumberNTR4950
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR8-jan-2015
- Secondary IDsMEC2014-108 2013-004134-15
- Public TitleIntranasal administration of oxytocin in PWS
- Scientific TitleIntranasal administration of oxytocin in children with Prader-Willi Syndrome. Effects on satiety and food intake, and social behaviour
- ACRONYM
- hypothesis
- Healt Condition(s) or Problem(s) studiedPrader-Willi syndrome, Diagnosis
- Inclusion criteria- Genetically confirmed diagnosis of Prader-Willi syndrome - Age between 6 and 14 years - Currently on growth hormone treatment for at least 1 year - Increased interest in food and/or problems social behavior
- Exclusion criteria- Severe psychiatric problems - Non cooperative behaviour - Allergic reactions or hypersensitivity for oxytocin - Serious illness - Cardiac abnormalities - Extremely low dietary intake of less than minimal required intake according to WHO - Medication to reduce weight (fat)
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blinding[default]
- control[default]
- group[default]
- Type[default]
- Studytype[default]
- planned startdate 1-jan-2015
- planned closingdate
- Target number of participants28
- InterventionsOxytocin intranasal spray
- Primary outcomeTo evaluate the effects of intranasal oxytocin administration on appetite, satiety and food intake in children with PWS.
- Secondary outcomeTo evaluate the effects of intranasal oxytocin administration on social behavior in children with PWS.
- TimepointsDay 1, day 29 and day 57.
- Trial web site
- status[default]
- CONTACT FOR PUBLIC QUERIESDrs R.J. Kuppens
- CONTACT for SCIENTIFIC QUERIESDrs R.J. Kuppens
- Sponsor/Initiator Dutch Growth Research Foundation
- Funding
(Source(s) of Monetary or Material Support)
Dutch Growth Research Foundation
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD8-jan-2015 - 23-feb-2015


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