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Completed

NCT Number: NCT03771560

Folinic Acid in Autism

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.

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Key information

Conditions

Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

5 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University of California, San Francisco

San Francisco, California, 94143, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Between ages 5 and 25

Exclusion criteria

  • Not currently taking folinic acid

Treatment and study plan

Folinic acid

Drug

subject will take folinic acid daily for 12 weeks

Other names: leucovorin calcium

Primary outcomes

  1. Aberrant Behavior Checklist (ABC) - Parent Reported Change

    Time frame: 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.

  2. Aberrant Behavior Checklist (ABC) - Teacher Reported Change

    Time frame: 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 outcomes

  1. Social Responsiveness Scale (SRS) - Parent Reported Change

    Time frame: 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.

  2. Social Responsiveness Scale (SRS) - Teacher Reported Change

    Time frame: 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.

  3. Pediatric Quality of Life (PedsQL) - Parent Reported Change

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Dec 11, 2018
Registry last updated
Dec 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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