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NCT05268744

Micronutrient Supplementation in Children With ASD

Completed Phase 2 Results posted Last updated 29 February 2024
What this trial tests

Phase 2 trial testing Micronutrient in Autism Spectrum Disorder in 16 participants. Completed in 30 January 2023.

Timeline
14 November 2022
Primary endpoint
14 January 2023
30 January 2023

Quick facts

Lead sponsorUniversity of California, San Francisco
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment16
Start date14 November 2022
Primary completion14 January 2023
Estimated completion30 January 2023
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of California, San Francisco

Who can join

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)
GroupValue95% CI
All Participants-2.9-7.1 – 1.4
ABI-S (Teacher)
GroupValue95% 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)
GroupValue95% CI
All Participants-8.1-18.4 – 2.2
SRS (Teacher)
GroupValue95% CI
All Participants0.8-9.8 – 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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Other recruiting trials for Autism Spectrum Disorder

Currently open trials in the same condition.

Other University of California, San Francisco trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing