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RECRUITING
NCT05754073
PHASE2

Oxytocin Effects on Bone in Children With Autism Spectrum Disorder

Sponsor: Elizabeth Austen Lawson

View on ClinicalTrials.gov

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

Interventions

DRUG

1. Intranasal oxytocin spray

30 IU, twice daily for 12 months in the experimental arm in double-blinded phase

DRUG

2. Intranasal placebo spray

30 IU, twice daily for 12 months in the placebo comparator arm in double-blinded phase

DRUG

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