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Micronutrient Supplementation in Children With ASD | Clinical Trials | Clareo Health

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COMPLETEDPhase 2NCT05268744

Micronutrient Supplementation in Children With ASD

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 wi...

Lead sponsor: University of California, San Francisco•1 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

University of California, San Francisco

Children enrolled in Oak Hill School will enroll in this study and take micronutrient supplement once a day for 8 weeks period. Behavioral measures and metabolites taken from Dried Blood Spots (DBS) will be collected pre and post treatment. Behavioral measures will be taken again at 12 weeks, after 4 weeks of not dosing.

Age

5 - 22 years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•1. Male or female, enrolled at Oak Hill School (OHS), age 6-22 and with a diagnosis of ASD.
•2. ASD diagnosis will be established by standard criteria (DSM-IV criteria and expert clinician review of medical records and child observation).
•3. Written informed consent obtained from the subject's legal representative and ability for subject to comply with the requirements of the study.

Exclusion Criteria

•1. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
•2. Taking multivitamins currently and unwilling to stop during the study period

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: February 29, 2024Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE2

Enrollment16

Start dateNov 2022

Last updatedFeb 29, 2024

Condition

Autism Spectrum Disorder

Locations shown

University of California, San Francisco

San Francisco, California

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 29, 2024Data synced to Clareo: June 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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