Folinic Acid in Autism

Phase 2

Completed

• Conditions: Autism Spectrum Disorder
• Interventions: Drug: folinic acid

• Registration Number: NCT03771560
• Lead Sponsor: University of California, San Francisco

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2018-02-14
• Study Start: 2018-02-15
• Primary Completion: 2018-06-30
• Study Completion: 2018-06-30
• Study First Submitted QC: 2018-12-08
• Study First Posted: 2018-12-11
• Results First Submitted: 2019-09-05
• Status Verified: 2019-11
• Results First Submitted QC: 2019-11-12
• Last Update Submitted: 2019-11-12
• Results First Posted: 2019-12-03
• Last Update Posted: 2019-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Between ages 5 and 25

Exclusion Criteria

• Not currently taking folinic acid

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Open-label	folinic acid	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.

Primary Outcome Measures

Name	Time	Method
Aberrant Behavior Checklist (ABC) - Parent Reported Change	Baseline to Week 12	The Aberrant Behavior Checklist - parent reported version measures aberrant behavior in children and young adults. There are 58 questions.The scoring of one question can range from 0 (not a problem) to 3 (severe) points on a Likert scale. The total possible score range for the ABC is 0 - 174. Analysis will be performed for mean of total score change over time.; Scoring from 0-3; Not a problem = 0, Slightly = 1, Moderately Serious =2, Severe =3; Lower score indicates better performance.
Aberrant Behavior Checklist (ABC) - Teacher Reported Change	Baseline to Week 12	The Aberrant Behavior Checklist - teacher reported version measures aberrant behavior in children and young adults. There are 58 questions. The scoring of ABC questions can range from 0 (not a problem) to 3 (severe) points on a likert scale. The total possible score range for the ABC is 0 - 174. Analysis will be performed for mean of total score change over time.; Scoring from 0-3; Not a problem = 0, Slightly = 1, Moderately Serious =2, Severe =3; Lower score indicates better performance.

Secondary Outcome Measures

Name	Time	Method
Social Responsiveness Scale (SRS) - Parent Reported Change	Baseline to Week 12	The Social Responsiveness Scale - parent reported version measures social ability in children and young adults. There are 65 questions. The questions on the scale with anchors 1 (Not True) - 4 (Almost Always True). 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. Analysis will be performed for mean of total score change over time.; Anchors Not True = 1 Sometimes True = 2 Often True = 3 Almost Always True = 4; Lower score indicates better performance.
Social Responsiveness Scale (SRS) - Teacher Reported Change	Baseline to Week 12	The Social Responsiveness Scale - teacher reported version measures social ability in children and young adults. There are 65 questions. The questions on the scale with anchors 1 (Not True) - 4 (Almost Always True). 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. Analysis will be performed for mean of total score change over time.; Anchors Not True = 1 Sometimes True = 2 Often True = 3 Almost Always True = 4; Lower score indicates better performance.
Pediatric Quality of Life (PedsQL) - Parent Reported Change	Baseline to Week 12	Pediatric Quality of Life is reported by parent only and it assesses improvement of the child's overall quality of life through questions about physical, emotional, social and school functioning. There are 23 questions. The scoring of PedsQL questions can range from 0 (Never) to 4 (Almost Always) points on a Likert scale. Questions are reversed scored and linearly transformed to a 0 - 100 scale for data analysis as follows: 0=100, 1=75, 2=50, 3=23, 4=0. The total score = sum of all the questions over the number of items answered on. The total possible score range for the PedsQL is 0 - 100. Analysis will be performed for mean of total score change over time.; Scoring from 0 to 4; Never = 0, Almost Never = 1, Sometimes = 2, Often = 3, Almost Always =4; Higher score indicates better performance.

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States