Oxytocin Effects on Bone Metabolism in Children With Autism Spectrum Disorder
Status:
Not yet recruiting
Trial end date:
2026-10-31
Target enrollment:
Participant gender:
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.