Actively Recruiting
Oxytocin Effects on Bone in Children With Autism Spectrum Disorder
Led by Elizabeth Austen Lawson · Updated on 2026-03-02
96
Participants Needed
2
Research Sites
265 weeks
Total Duration
On this page
Sponsors
E
Elizabeth Austen Lawson
Lead Sponsor
U
United States Department of Defense
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Oxytocin Effects on Bone in Children With Autism Spectrum Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ages 6 to 18 years old at randomization
- Body mass index (BMI) at or above the 5th percentile
- Expert clinical diagnosis of autism spectrum disorder
- Parent or guardian available to provide informed consent
You will not qualify if you...
- Diagnosis of Fragile X, tuberous sclerosis, William's syndrome, Angelman's syndrome, Noonan syndrome, or other genetic syndromes affecting heart or bone density
- Conditions causing low bone density such as hypogonadism
- Use of bone-impacting medications other than calcium or vitamin D supplements, including specific anti-seizure drugs, oral glucocorticoids, or hormonal contraceptive injections
- Low sodium levels (hyponatremia)
- Liver enzyme levels more than three times the normal limit
- Estimated glomerular filtration rate (eGFR) below 60
- Substance use disorder within the last 6 months
- History of coronary artery disease, heart failure, certain heart muscle diseases, serious arrhythmias, or prolonged QT interval
- Active seizures within 6 months before screening or baseline visit
- Pregnancy, lactation, or refusal to use contraception if sexually active
- Previous oxytocin treatment within 2 months before randomization
- Inability to cooperate with medication, blood draws, or imaging despite training
- Caregivers unable to speak English or unable to comply with study requirements
- Any significant illness, medication, or medical device that might interfere with participation or safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
2
University of Virginia Medical Center
Charlottesville, Virginia, United States, 22903
Actively Recruiting
Research Team
M
Madhusmita Misra, MD, MPH
CONTACT
S
Sarah Smith, DNP
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here