A Randomized, Double-blind, Placebo-controlled Study of Intranasal Oxytocin for Bone Health in Children With Autism Spectrum Disorder

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 18
Healthy Volunteers: f
View:

• Ages 6 to 18 years old at Randomization

• BMI greater than or equal to the 5th percentile

• Expert clinical diagnosis of ASD

• Availability of parent/guardian to provide informed consent

Locations
United States
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Virginia
University of Virginia Medical Center
RECRUITING
Charlottesville
Contact Information
Primary
Madhusmita Misra, MD, MPH
abp6bd@uvahealth.org
434-924-9141
Backup
Sarah Smith, DNP
mghboxstudy@mgb.org
617-726-3870
Time Frame
Start Date: 2023-08-01
Estimated Completion Date: 2028-08-31
Participants
Target number of participants: 96
Treatments
Experimental: 1. Intranasal Oxytocin
Intranasal oxytocin spray (30 IU twice daily) for 12 months in the double-blinded phase followed by intranasal oxytocin spray (30 IU twice daily) for 6-months in the open-label phase
Placebo_comparator: 2. Placebo
Intranasal placebo spray (30 IU twice daily (total 60 IU per day) for 12 months followed by intranasal oxytocin spray (30 IU twice daily) for 6-months in the open-label phase
Related Therapeutic Areas
Sponsors
Collaborators: United States Department of Defense, University of Virginia
Leads: Elizabeth Austen Lawson

This content was sourced from clinicaltrials.gov