This study is looking at whether intranasal oxytocin spray can improve bone health in children with Autism Spectrum Disorder (ASD). Children with ASD are at a higher risk for low bone density. Researchers want to see if giving oxytocin, a hormone that can help with bone formation, can make a difference. You could be eligible if you are 6 to 18 years old, have an ASD diagnosis, and meet other health criteria. The study will compare intranasal oxytocin spray to a placebo (an inactive spray) for 12 months, followed by 6 months where everyone receives intranasal oxytocin spray. The main goal is to see if there's a difference in bone mineral density (BMD) after 12 months. The study aims to enroll 96 participants, but its current status is unclear.

Study design

This is a randomized, double-blind study, meaning participants are randomly assigned to receive either intranasal oxytocin spray or a placebo, and neither you nor the study team will know which you are receiving for the first 12 months. All 96 participants will then receive intranasal oxytocin spray for an additional 6 months.

What's involved

You would have study visits at screening, baseline, week 2, and months 6, 12, and 18. There will also be phone calls every two weeks for the first two months, and then monthly for the rest of the study.

Compensation

Not stated in the trial record.

Follow-up

The primary outcome is measured at 12 months, and the study involves visits up to 18 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.