Folinic Acid in Autism
An Examination of Changes in Urinary Metabolites With Use of Folinic Acid in Children With Autism Spectrum Disorder (ASD)
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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San Francisco, California, Estados Unidos, 94143
- University of California, San Francisco
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Between ages 5 and 25
Exclusion Criteria:
- Not currently taking folinic acid
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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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.
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subject will take folinic acid daily for 12 weeks
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Aberrant Behavior Checklist (ABC) - Parent Reported Change
Periodo de tiempo: Baseline to Week 12
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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
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Aberrant Behavior Checklist (ABC) - Teacher Reported Change
Periodo de tiempo: 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. |
Baseline to Week 12
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Social Responsiveness Scale (SRS) - Parent Reported Change
Periodo de tiempo: Baseline to Week 12
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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
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Social Responsiveness Scale (SRS) - Teacher Reported Change
Periodo de tiempo: 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. |
Baseline to Week 12
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Pediatric Quality of Life (PedsQL) - Parent Reported Change
Periodo de tiempo: Baseline to Week 12
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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
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Robert Hendren, DO, University of California, San Francisco
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Desordenes mentales
- Trastornos del neurodesarrollo
- Trastornos del desarrollo infantil generalizados
- Trastorno autista
- Desorden del espectro autista
- Efectos fisiológicos de las drogas
- Agentes Protectores
- Micronutrientes
- Vitaminas
- Antídotos
- Complejo de vitamina B
- Hematínicos
- Leucovorina
- Levoleucovorina
- Ácido fólico
Otros números de identificación del estudio
- Folinic acid
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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