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Billet publié sur Twitter/X le 08/03/2023 13:52

Twitter/X Essai clinique clinicaltrials.gov Extrait cité dans le billet Question posée par Dawson dans le billet Lien intégré au billet Termes sur l’autisme

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Essai clinique Récupéré Publication clinicaltrials.gov

Elizabeth Austen Lawson, United States Department of Defense, University of Virginia (2023). Oxytocin Effects on Bone in Children With Autism Spectrum Disorder. ClinicalTrials.gov. Elizabeth Austen Lawson.

Date de publication
01/08/2023
Identifiant
NCT05754073
Auteurs
Elizabeth Austen Lawson, United States Department of Defense, University of Virginia
Source
ClinicalTrials.gov
Type de référence
clinical_trial
Éditeur
Elizabeth Austen Lawson
Source de métadonnées
clinicaltrials.gov

Résumé

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.