Oxytocin Effects on Bone in Children With Autism Spectrum Disorder

Recruiting Phase 2 Interventional Study
Autism Spectrum Disorder Bone Health
Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
6 – 18
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Prevention
Participants needed
96 (estimated)
Sponsor
Elizabeth Austen Lawson · Other
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About This Trial
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 intr…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Ages 6 to 18 years old at Randomization 2. BMI greater than or equal to the 5th percentile 3. Expert clinical diagnosis of ASD 4. Availability of parent/guardian to provide informed consent Exclusion Criteria: 1. Fragile X, tuberous sclerosis, William's syndrome, Angelman's…
Contacts

Madhusmita Misra, MD, MPH

434-924-9141

abp6bd@uvahealth.org

CONTACT

Sarah Smith, DNP

617-726-3870

mghboxstudy@mgb.org

CONTACT