RecruitingPhase 2NCT05754073

Oxytocin Effects on Bone in Children With Autism Spectrum Disorder

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


Sponsor

Elizabeth Austen Lawson

Enrollment

96 participants

Start Date

Aug 1, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 6 YearsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study explores whether the hormone oxytocin — sometimes called the 'bonding hormone' — can help improve bone density in children with autism spectrum disorder (ASD). Children with ASD often have lower bone density than their peers, which can lead to fractures and long-term health problems. Oxytocin is already being studied for its effects on social behaviour in autism, but this trial specifically examines its impact on bone health. Participants must be children aged 6–18 with a clinical diagnosis of ASD and a body mass index at or above the 5th percentile. A parent or guardian must be available to provide consent. Children with certain genetic syndromes, conditions affecting bone density (like hypogonadism), specific medications that impact bone (like some anti-seizure drugs), seizures in the last 6 months, heart problems, or kidney/liver dysfunction are excluded. Participants will receive oxytocin (or a placebo) and attend regular visits for blood tests and bone density scans. The research matters because bone health is a neglected concern in autism, and if oxytocin — already under investigation for other symptoms — also improves bone density, it could offer a dual benefit for children with ASD.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG1. Intranasal oxytocin spray

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

DRUG2. Intranasal placebo spray

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

DRUG3. 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

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NCT05754073


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