Micronutrient Supplementation in Children With ASD

University of California San Francisco (UCSF)

Status and phase: Completed; Phase 2

Conditions: Autism Spectrum Disorder

Treatments: Drug: Micronutrient

Study type: Interventional

Funder types: Other

Identifiers

NCT05268744

22-35971

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 16 patients

Sex: All

Ages: 5 to 22 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Micronutrient

Experimental group

Description:

In this open-label trial, all subjects will receive the daily dose of micronutrient, in the form of one lightning stick per day, which contains 2.9 grams of micronutrients per stick. It will be delivered in a powder form taken sublingually.

Treatment:

Drug: Micronutrient