Actively Recruiting
Intranasal Oxytocin for Bone Health in Children With Autism Spectrum Disorder A Randomized, Double-blind, Placebo-controlled Study
Led by Elizabeth Austen Lawson · Updated on 2026-03-02
96
Participants Needed
2
Research Sites
52 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
Researchers are studying the effects of intranasal oxytocin on bone health in children aged 6 to 18 years with autism spectrum disorder ASD. ASD is characterized by challenges in social interaction and communication and is associated with low bone mineral density and low oxytocin levels. This trial aims to see if oxytocin can improve bone density and overall bone health in these children compared to a placebo. Participants will be randomly assigned to receive either intranasal oxytocin spray 30 IU twice daily or a placebo spray for 12 months in a double-blind phase. Following this, all participants will receive intranasal oxytocin 30 IU twice daily for an additional 6 months during an open-label phase. The study includes regular visits for assessments at baseline, week 2, and months 6, 12, and 18, along with phone calls every two weeks initially and then monthly. During the study, participants will undergo physical exams, measurements of body size, electrocardiograms, blood tests for hormones and bone metabolism markers, questionnaires about diet and exercise, and imaging to assess bone density and body composition. Researchers will monitor side effects and measure changes in bone density and structure over time. The primary outcome is the change in whole body bone mineral density after 12 months of treatment.
CONDITIONS
Brief 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
- Clinical diagnosis of autism spectrum disorder
- Parent or guardian able to provide informed consent
You will not qualify if you...
- Diagnosed with Fragile X, tuberous sclerosis, William's syndrome, Angelman's syndrome, Noonan syndrome, or other single gene defects affecting heart or bone density
- Conditions contributing to low bone density such as hypogonadism
- Use of medications impacting bone health other than calcium or vitamin D supplementation, including certain anti-seizure drugs, oral glucocorticoids, or hormonal contraceptive injections
- Hyponatremia
- Liver enzyme levels more than three times normal
- Estimated glomerular filtration rate below 60
- Substance use disorder within the past 6 months
- History of coronary artery disease, heart failure, arrhythmias, or prolonged QT interval
- Seizures active within 6 months before screening or baseline
- Pregnancy, lactation, or refusal of contraception if sexually active
- Oxytocin treatment within 2 months prior to randomization
- Inability to cooperate with medication, blood draws, or imaging despite behavior training
- Caregivers unable to speak English or consistently attend visits
- Any significant illness or condition that may interfere with participation or safety
Research Team
M
Madhusmita Misra, MD, MPH
S
Sarah Smith, DNP
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