University of North Carolina Chapel Hill
Chapel Hill, North Carolina, 27517, United States
Completed
NCT Number: NCT02006381
Oxytocin Levels in Typically Developing Boys
Measuring basal levels of plasma oxytocin in individuals with typical development across childhood and adolescence using both extracted and unextracted EIA methods.
Completed
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Conditions
Age range
3 year–17 year
Sex eligibility
Male
Study type
Observational
Primary location
About this study
Measuring basal levels of plasma oxytocin in individuals with typical development across childhood and adolescence using both extracted and unextracted EIA methods. This study is necessary since there is great variability in reported plasma oxytocin in typically developing children from other studies as well as up to 1000 fold variability in such levels using different assay procedures. Further existing studies have not clearly described variation in levels with age. all samples will be taken in the afternoon.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Between 3 and 17 years old, inclusive
- Consent of parent or guardian.
Exclusion criteria
- Exclusion Criteria for Healthy Control Participants:
- Female gender
- Evidence of a mental health diagnosis
- Evidence of significant medical condition (ie: renal, cardiovascular or genetic disease)
- First degree family member with an ASD diagnosis
Treatment and study plan
Primary outcomes
-
Plasma Oxytocin Levels
Time frame: Baseline oxytocin level at visit 1 (time zero)
20 children in each of 3 age cohorts 3-6, 7-12, and 13-17 will participate. Plasma oxytocin levels will be taken at the screening appointment.
Secondary outcomes
-
Inflammatory markers
Time frame: at single time point
C reactive protein and cytokine panel
Sponsors and collaborators
Lead sponsor
University of North Carolina, Chapel Hill
Other
Registry information
Official study title
Ontogenic Measurement of Plasma Oxytocin in Typically Developing Boys Using Extracted and Unextracted EIA Methods
Important dates
- Study start
- 2013
- Primary completion
- 2015
- Study completion
- 2015
- First posted
- Dec 10, 2013
- Registry last updated
- Sep 22, 2015
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.