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Oxytocin Effects on Bone in Children With Autism Spectrum Disorder
Sponsor: Elizabeth Austen Lawson
Summary
This is a randomized, double blind, placebo-controlled study of the effects of intranasal oxytocin on bone health in children with autism spectrum disorder, ages 6-18 years old. Subjects will be randomized to receive intranasal oxytocin or placebo (30 IU, 2 times daily) for 12 months in the double-blind phase, followed by a 6-month open label phase during which all study subjects will receive intranasal oxytocin (30 IU, 2 times daily). Study visits include screening to determine eligibility, followed by study visits at baseline, week 2, and months 6, 12, 18 and phone calls every two weeks for the first two months and monthly thereafter for the duration of the study. Study assessments include history and physical examinations, anthropometric measurements, electrocardiogram (EKG), adverse event monitoring, laboratory tests for chemistries, hormones and biomarkers for bone metabolism, questionnaires regarding diet and exercise, and imaging to assess body composition, bone density and structure.
Official title: A Randomized, Double-blind, Placebo-controlled Study of Intranasal Oxytocin for Bone Health in Children With Autism Spectrum Disorder
Key Details
Gender
All
Age Range
6 Years - 18 Years
Study Type
INTERVENTIONAL
Enrollment
96
Start Date
2023-08-01
Completion Date
2028-08-31
Last Updated
2026-03-02
Healthy Volunteers
No
Conditions
Interventions
1. Intranasal oxytocin spray
30 IU, twice daily for 12 months in the experimental arm in double-blinded phase
2. Intranasal placebo spray
30 IU, twice daily for 12 months in the placebo comparator arm in double-blinded phase
3. Intranasal Oxytocin spray
30 IU, twice daily for 6 months in both experimental and placebo comparator arm in open-label phase
Locations (2)
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Virginia Medical Center
Charlottesville, Virginia, United States