RECRUITING

Oxytocin Effects on Bone Metabolism in Children With Autism Spectrum Disorder

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-08-01
Study Completion:2026-10-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05754073

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Years to 18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Ages 6 to 18 years old at Randomization
  2. 2. BMI between the 10th-85th percentiles
  3. 3. Expert clinical diagnosis of ASD confirmed using the Diagnostic and Statistical Manual of Mental Disorders (DSM) -5 Checklist and a Social Communication Questionnaire (SCQ)-Lifetime
  4. 4. Availability of parent/guardian to provide informed consent
  5. 5. If cognitively able, the subject must be able to provide informed assent/consent
  1. 1. Fragile X, tuberous sclerosis, and other single gene defects that are syndromic
  2. 2. Other conditions that may contribute to low bone density (e.g., hyperprolactinemia, hypogonadism)
  3. 3. Medications that may impact bone such as specific anti-seizure medications, oral glucocorticoids, combined hormonal contraception
  4. 4. Hyponatremia
  5. 5. Creatinine or liver enzymes more than twice the upper limit of the normal range
  6. 6. Changes in doses of antipsychotics that can cause hyperprolactinemia within 2 months of the baseline visit
  7. 7. Substance use disorder within the last 6 months
  8. 8. History of known coronary artery disease, heart failure, reduced ejection fraction, hypertrophic cardiomyopathy, ventricular arrhythmias, or prolonged QT
  9. 9. Active seizures within 6 months preceding the Screening visit or the Baseline visit
  10. 10. Subjects who are pregnant, lactating, or who refuse contraception if sexually active
  11. 11. Subjects who have had previous treatment with OXT (within 2 months of Randomization)
  12. 12. Subjects who are not able to cooperate with medication administration, blood drawing, or imaging procedures despite behavior training
  13. 13. Caregivers who are unable to speak English, be consistently present at study visits to report on symptoms or, per the judgement of the data collection team, are unable to comply with the protocol

Contacts and Locations

Study Contact

Madhusmita Misra, MD, MPH
CONTACT
617-726-5790
mmisra@mgh.harvard.edu
Sarah Smith, DNP
CONTACT
617-726-9394
ssmith133@mgh.harvard.edu

Study Locations (Sites)

Massachusetts General Hospital
Boston, Massachusetts, 02114
United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-01
Study Completion Date2026-10-31

Study Record Updates

Study Start Date2023-08-01
Study Completion Date2026-10-31

Terms related to this study

Keywords Provided by Researchers

  • Autism spectrum disorder
  • Bone density
  • Oxytocin
  • Peri-pubertal children

Additional Relevant MeSH Terms

  • Autism Spectrum Disorder
  • Bone Health