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Folinic Acid in Autism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03771560
Recruitment Status : Completed
First Posted : December 11, 2018
Results First Posted : December 3, 2019
Last Update Posted : December 3, 2019
Sponsor:
Information provided by (Responsible Party):
Robert Hendren, 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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Drug: folinic acid Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Examination of Changes in Urinary Metabolites With Use of Folinic Acid in Children With Autism Spectrum Disorder (ASD)
Actual Study Start Date : February 15, 2018
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : June 30, 2018


Arm Intervention/treatment
Experimental: Open-label
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.
Drug: folinic acid
subject will take folinic acid daily for 12 weeks
Other Name: leucovorin calcium




Primary Outcome Measures :
  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 Outcome Measures :
  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.




Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Between ages 5 and 25

Exclusion Criteria:

  • Not currently taking folinic acid

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03771560


Locations
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United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Robert Hendren, DO University of California, San Francisco
  Study Documents (Full-Text)

Documents provided by Robert Hendren, University of California, San Francisco:

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Responsible Party: Robert Hendren, Professor of Psychiatry, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03771560    
Other Study ID Numbers: Folinic acid
First Posted: December 11, 2018    Key Record Dates
Results First Posted: December 3, 2019
Last Update Posted: December 3, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Leucovorin
Folic Acid
Levoleucovorin
Antidotes
Protective Agents
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Hematinics