Oxytocin Effects on Bone in Children With Autism Spectrum Disorder

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Elizabeth Austen Lawson
Study ID
NCT05754073
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
6 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • 1. Intranasal oxytocin spray — DRUG
    30 IU, twice daily for 12 months in the experimental arm in double-blinded phase
  • 2. Intranasal placebo spray — DRUG
    30 IU, twice daily for 12 months in the placebo comparator arm in double-blinded phase
  • 3. Intranasal Oxytocin spray — DRUG
    30 IU, twice daily for 6 months in both experimental and placebo comparator arm in open-label phase

Study Details

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.

Key Dates

Start date
Aug 1, 2023
Status verified
Nov 2025
Primary completion
Aug 31, 2027
Completion
Aug 31, 2028

Study Design

Enrollment
96 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • 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

Primary Outcome Measure

Difference between IN OXT vs placebo in 12-month change in whole body less head BMD Z-scores. [ Time Frame: 12 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
Sarah Smith, DNP
[email protected]
617-726-3870
Elizabeth A Lawson, MD (PRINCIPAL_INVESTIGATOR)
University of Virginia Medical CenterCharlottesvilleVirginia22903
Andrea Marrs, MS
[email protected]
434-982-0871
Madhusmita Misra, MD,MPH (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
Autism spectrum disorder
By specialty
Pediatrics
By research site
Massachusetts General Hospital· Boston, MAUniversity of Virginia Medical Center· Charlottesville, VA

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