Ignite Creation Date:
2024-05-06 @ 6:43 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05754073
Status:
RECRUITING
Last Update Posted:
2023-10-18
First Post:
2023-02-22
Brief Title:
Oxytocin Effects on Bone Metabolism in Children With Autism Spectrum Disorder
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Study of Intranasal Oxytocin for Bone Health in Children With Autism Spectrum Disorder
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
The prevalence of autism spectrum disorder ASD a group of behaviorally-defined disorders characterized by impaired social interactions and verbal and non-verbal communication is increasing among children Studies have shown that children with ASD are at a higher risk for low bone mineral density and fractures ASD is also characterized by low levels of oxytocin OXT a peptide hormone with prosocial effects In addition OXT promotes bone formation over resorption and low levels of OXT are associated with poor bone health Hence OXT administration represents a potential strategy for improving bone health in children with ASD particularly during the childhood and adolescent years when bone accrual peaks
The investigators aim to examine i whether intranasal OXT administration vs placebo increases areal bone mineral density BMD and improves overall bone health in children with ASD and ii other pathways whereby OXT may impact bone health favorably
The investigators will enroll 96 participants 6-18 years old with ASD and randomize them into the intranasal oxytocin vs placebo groups The study subjects will undergo 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
The investigators aim to examine i whether intranasal OXT administration vs placebo increases areal bone mineral density BMD and improves overall bone health in children with ASD and ii other pathways whereby OXT may impact bone health favorably
The investigators will enroll 96 participants 6-18 years old with ASD and randomize them into the intranasal oxytocin vs placebo groups The study subjects will undergo 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None