Healthy BoysNCT02006381
Oxytocin Levels in Typically Developing Boys
An observational study of Healthy Boys, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
Measuring basal levels of plasma oxytocin in individuals with typical development across childhood and adolescence using both extracted and unextracted EIA methods. Read more about this study
- Who is it for?
- Ages 3 to 17 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Boys
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Apr 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 17 years
- Men only
- Healthy volunteers accepted
- Child
Study population: This population will be a community sample representative of the community of the area.
Who may be able to join
- Between 3 and 17 years old, inclusive
- Consent of parent or guardian.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, 27517
About this study
Official title: Ontogenic Measurement of Plasma Oxytocin in Typically Developing Boys Using Extracted and Unextracted EIA Methods
Measuring basal levels of plasma oxytocin in individuals with typical development across childhood and adolescence using both extracted and unextracted EIA methods.
Read the 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.
- Conditions
- Healthy Boys
- Keywords
- healthy boys, plasma oxytocin, pediatric
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline oxytocin level at visit 1 (time zero)
Secondary outcomes (1)
Inflammatory markers
C reactive protein and cytokine panel
Measured: at single time point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy BoysStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Linmarie Sikich, MD, University of North Carolina, Chapel Hill
- Investigators
- Linmarie Sikich, MD, Principal investigator, UNC-Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02006381
- Sponsor's protocol ID
- 13-3288
- Status last verified
- Sep 2015
- First submitted
- 22 Nov 2013
- Last updated
- 22 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ontogenic Measurement of Plasma Oxytocin in Typically Developing Boys Using Extracted and Unextracted EIA Methods
- ClinicalTrials.gov ID
- NCT02006381
- Acronym / sponsor ID
- 13-3288
- Conditions
- Healthy Boys
- Keywords
- healthy boys, plasma oxytocin, pediatric
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 10 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- This population will be a community sample representative of the community of the area.
Key inclusion criteria (2 listed)
- Between 3 and 17 years old, inclusive
- Consent of parent or guardian.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Inflammatory markers
Time frame: at single time point
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linmarie Sikich, MD principal investigator
UNC-Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Boys, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma Oxytocin Levels (time frame: Baseline oxytocin level at visit 1 (time zero)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2015.