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Intranasal administration of oxytocin in children with Prader-Willi Syndrome. A randomized, open-label, cross-over trial of different treatment regimens of oxytocin administration. Effects on eating behaviour and social behaviour.

Intranasal administration of oxytocin in children with Prader-Willi Syndrome. A randomized, open-label, cross-over trial of different treatment regimens of oxytocin administration. Effects on eating behaviour and social behaviour. - Intranasal administration of oxytocin in children with PWS

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON43050
Enrollment
44
Registered
2016-12-22
Start date
Unknown
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prader-Willi Syndrome

Interventions

Cross-over intervention with intranasal oxytocin in different dosing regimens depending on study group and body surface
Behaviour
Open-label
Oxytocin
Prader-Willi Syndrome

Sponsors

Stichting Kind en Groei
Lead Sponsor

Eligibility

Age
2 Years to 17 Years

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Genetically confirmed diagnosis of Prader-Willi syndrome - Age between 3 and 16 years - Currently on growth hormone treatment for at least 1 year - Behavioural problems (for example temper tantrums and autistic behaviour) and/or be in nutritional phase 2b or 3 according to Miller.;For fMRI: age > 6 years

Exclusion criteria

Exclusion criteria: - Severe psychiatric problems - Non-cooperatieve behaviour - Allergic reactions or hypersensitivity for oxytocin - Serious illness - Cardiac abnormalities - Extremely low dietary intake or less than minimal required intake acoording to WHO - Medication to reduce weight (fat)

Design outcomes

Primary

MeasureTime frame
The effect of different dosing regimens of intranasal oxytocin administration on changes in social behaviour assessed by the oxytocin study questionnaire.—

Secondary

MeasureTime frame
The effect of different dosing regimens of intranasal oxytocin administration on changes in: - Body composition (anthropometric measurements, BMI and DXA-scan) - Quality of life (DUX25 and DUXPWS) - Hyperphagia questionnaire (hyperphagia questionnaire Dykens) - Theory of Mind (TOM test) - Change in social and eating behaviour (diary) - fMRI (BOLD responses during a task with food pictures - Laboratory parameters (oxytocin in saliva and blood) - Safety parameters (laboratory parameters and medical assessments).—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)