Folinic Acid in Autism

University of California San Francisco (UCSF)

Status and phase: Completed; Phase 3; Phase 2

Conditions: Autism Spectrum Disorder

Treatments: Drug: folinic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT03771560

Folinic acid

Details and patient eligibility

About

An examination of changes in urinary metabolites with use of folinic acid in children with autism spectrum disorder (ASD). Investigators will also measure behavioral measures and academic measures monthly at school with teachers and parents report.

Full description

Children enrolled in Oak Hill School will enroll in this study and take folinic acid supplement twice a day for 12 weeks period. Behavioral measures and urinary metabolites will be collected pre and post treatment. Behavioral measures will be taken again at 16 weeks, after 4 weeks of not dosing.

Enrollment: 18 patients

Sex: All

Ages: 5 to 25 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Between ages 5 and 25

Exclusion criteria

• Not currently taking folinic acid

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Open-label

Experimental group

Description:

In this open-label trial, all subjects will receive the twice daily dose of folinic acid. Folinic acid will be delivered in pill form at a weight-based dose.

Treatment:

Drug: folinic acid