Folinic Acid in Autism

Autism Spectrum Disorder Clinical Trial

Official title:

An Examination of Changes in Urinary Metabolites With Use of Folinic Acid in Children With Autism Spectrum Disorder (ASD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03771560
• Other study ID #: Folinic acid
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: February 15, 2018
• Est. completion date: June 30, 2018

Study information

• Verified date: November 2019
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: June 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 25 Years

Eligibility

Inclusion Criteria:

• Between ages 5 and 25

Exclusion Criteria:

• Not currently taking folinic acid

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder

Intervention

Drug:
• folinic acid
subject will take folinic acid daily for 12 weeks

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aberrant Behavior Checklist (ABC) - Parent Reported Change	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.	Baseline to Week 12
Primary	Aberrant Behavior Checklist (ABC) - Teacher Reported Change	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.	Baseline to Week 12
Secondary	Social Responsiveness Scale (SRS) - Parent Reported Change	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.	Baseline to Week 12
Secondary	Social Responsiveness Scale (SRS) - Teacher Reported Change	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.	Baseline to Week 12
Secondary	Pediatric Quality of Life (PedsQL) - Parent Reported Change	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.	Baseline to Week 12