Intranasal administration of oxytocin in children with Prader-Willi Syndrome. A randomized, double-blind, placebo-controlled cross-over trial. Effects on satiety and food intake, and social behaviour.;Amendment: Six months open-label extension to the original study
Recruiting
- Conditions
- 10083624Prader-Willi syndrome
- Registration Number
- NL-OMON41393
- Lead Sponsor
- Stichting Kind en Groei
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 28
Inclusion Criteria
Children with Prader-Willi syndrom, genetically confirmed diagnosis
Age between 6 and 14 years
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- Change 4 weeks oxytocin versus 4 week placebo on eating behaviour (Dykens<br /><br>hyperphagia questionnaire)<br /><br>- Difference in eating behaviour between start and after 6 months of oxytocin<br /><br>nasal spray (Dykens hyperphagia questionnaire) </p><br>
- Secondary Outcome Measures
Name Time Method