Oxytocin Levels in Typically Developing Boys | NCT02006381

Studies
Oxytocin Levels in Typically Developing Boys

NCT02006381

Sponsor

University of North Carolina, Chapel Hill

Status

Completed

Last Update Posted

Sep 22, 2015Estimated

Enrollment

60Actual

Phase

Not provided

Conditions

Healthy Boys

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2013

Primary Completion Date

Apr 2015Actual

Completion Date

Apr 2015Actual

First Submitted Date

Nov 22, 2013

First Submission Date that Met QC Criteria

Dec 4, 2013

First Posted Date

Dec 10, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 18, 2015

Last Update Posted Date

Sep 22, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Linmarie Sikich, MD, Associate Professor of Psychiatry, University of North Carolina, Chapel HillPrincipal Investigator

Lead Sponsor

University of North Carolina, Chapel HillOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Measuring basal levels of plasma oxytocin in individuals with typical development across childhood and adolescence using both extracted and unextracted EIA methods.

Detailed Description

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Age 3-6		This will include 10 typically developing boys age 3-6
Age 7-12		This will include 10 typically developing boys age 7-12
Age 13-17		This will include 10 typically developing boys age 13-17

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Plasma Oxytocin Levels	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.	Baseline oxytocin level at visit 1 (time zero)

Secondary Outcomes

Measure	Description	Time Frame
Inflammatory markers	C reactive protein and cytokine panel	at single time point

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

This population will be a community sample representative of the community of the area.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Linmarie Sikich, MD	UNC-Chapel Hill	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of North Carolina Chapel Hill		Chapel Hill	North Carolina	27517	United States