Oxytocin Effects on Bone in Children With Autism Spectrum Disorder (NCT05754073)
A Randomized, Double-blind, Placebo-controlled Study of Intranasal Oxytocin for Bone Health in Children With Autism Spectrum Disorder
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Massachusetts General Hospital — Boston, Massachusetts
Age range: 6 Years to 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (2 Sites)
- Massachusetts General Hospital — Boston, Massachusetts
- University of Virginia Medical Center — Charlottesville, Virginia
📞 Contact the Study Coordinator
Phone: (434) 924-9141
Email: abp6bd@uvahealth.org
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Autism Spectrum Disorder
- Improving the Part C Early Intervention Service Delivery System for Children With ASD — Chicago, Illinois
- Treatment to Improve Sleep in Caregivers With Insomnia and a Child With Autism — Philadelphia, Pennsylvania
- Transcranial Magnetic Stimulation on Neural and Behavioral Facets of Social Cognition in Autism Spectrum Disorder — New Haven, Connecticut
- PRISM Intervention Study — Los Angeles, California
- ML-004 Open-Label Extension Study in Adults and Adolescents With Autism Spectrum Disorders (ASD) — Dothan, Alabama
- MTT for Children With ASD Who Have Gastrointestinal Disorders — Tempe, Arizona
Explore by condition: All Autism Spectrum Disorder clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.