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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open-label | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| folinic acid | Drug | subject will take folinic acid daily for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Hendren, DO | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Folinic Acid 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. folinic acid: subject will take folinic acid daily for 12 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Children with ASD enrolled in Oak Hill school and completed the entire study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Folinic Acid 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. folinic acid: subject will take folinic acid daily for 12 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline to Week 12 |
|
4 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Folinic Acid 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. folinic acid: subject will take folinic acid daily for 12 weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upset Stomach | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robert Hendren | UCSF | 415-502-3500 | STAR@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 21, 2017 | Sep 5, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D002955 | Leucovorin |
| ID | Term |
|---|---|
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
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| Baseline to Week 12 |
| 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 |
| 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 |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
|
| 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. | Deleted one outlier for data analysis; deleted one subject because of missing survey time point from teacher. | Posted | Mean | 95% Confidence Interval | score on a scale | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | 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. | Deleted one outlier for data analysis; deleted one subject because of missing survey time point from teacher. | Posted | Median | 95% Confidence Interval | score on a scale | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline to Week 12 |
|
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 5 |
| 12 |
| Dry mouth | General disorders | Non-systematic Assessment |
|
| Cold | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Increased aggression | Psychiatric disorders | Non-systematic Assessment |
|
| Blood in Stool | Gastrointestinal disorders | Non-systematic Assessment |
|
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| D011621 |
| Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |