Adults 5 to 22, any sex, with Autism Spectrum Disorder. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in the Autism Behavior Inventory, Short Form (ABI-S)Primary· Baseline to Week 8
The ABI-S is an observer-reported outcome scale designed specifically to measure change and severity of Autism Spectrum Disorder (ASD) symptoms. ABI-S will be measured by both parents and teachers. There are 24 questions. The scoring of ABI-S questions can range from 0-3 (with possible reverse scoring) based on scoring instructions for data analysis. The total range of score is between 0 and 72. Lower score indicates better performance.
ABI-S (Parent)
Group
Value
95% CI
All Participants
-2.9
-7.1 – 1.4
ABI-S (Teacher)
Group
Value
95% CI
All Participants
-0.8
-4.4 – 2.8
Change in the Social Responsiveness Scale (SRS)Primary· Baseline to Week 8
SRS measures social ability in children and young adults. SRS will be measured by both parents and teachers. There are 65 questions. The scoring of SRS questions can range from 0-3 (with possible reverse scoring) based on scoring instructions for data analysis. The total possible score range for the SRS is 0 - 195. Lower score indicates better performance.
SRS (Parent)
Group
Value
95% CI
All Participants
-8.1
-18.4 – 2.2
SRS (Teacher)
Group
Value
95% CI
All Participants
0.8
-9.8 – 11.4
Sponsor's own description
An open-label examination of changes in metabolites with use of micronutrients in children with autism spectrum disorder (ASD). Investigators will also measure behavioral measures monthly at school with teachers and parents report.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by University of California, San Francisco
Last refreshed: 29 February 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05268744.