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Oxytocin Effects on Bone in Children With Autism Spectrum Disorder

NCT05754073 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2026-03-02

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • University of Virginia

    collaborator OTHER

  • Elizabeth Austen Lawson

    lead OTHER

Principal Investigators

  • Elizabeth A Lawson, MD · Neuroendocrine Unit Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-01
Primary Completion
2027-08-31
Completion
2028-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05754073 on ClinicalTrials.gov