Autism Spectrum Disorder Clinical Trial
Official title:
Ketogenic Diet Therapy for Autism Spectrum Disorder
NCT number | NCT02477904 |
Other study ID # | HON1403 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 2015 |
Est. completion date | April 28, 2017 |
Verified date | September 2019 |
Source | Shriners Hospitals for Children |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will assess the effectiveness of the ketogenic diet (high-fat, low-carbohydrate, and moderate protein) in treating autism spectrum disorder (ASD). Three study groups will be comprised of children (2-21 years of age) based on whether or not they have ASD and receive the ketogenic diet - ASD/ketogenic diet, ASD/non-ketogenic diet, and non-ASD/non-ketogenic diet.
Status | Completed |
Enrollment | 119 |
Est. completion date | April 28, 2017 |
Est. primary completion date | April 28, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 2 Years to 21 Years |
Eligibility |
Inclusion Criteria: - Ages 2-21 years. - Primary diagnosis of autism spectrum disorder. - Parent/legal guardian and child able to read or understand English, and able/willing to provide informed consent/assent. - Females of childbearing potential must have a negative pregnancy test result and agree to use a medically acceptable method of contraception throughout the entire study period and for 30 days after the last dose of study drug - childbearing potential is defined a girls who are > Tanner stage 2 and urine pregnancy tests are acceptable. Exclusion Criteria: - Known cardiac disorder including arrhythmias or hypertension. - BMI < 3rd%ile. - Carnitine deficiency (primary). - Carnitine palmitoyltransferase (CPT) I or II deficiency. - Carnitine translocase deficiency. - Beta-oxidation defects - medium-chain acyl dehydrogenase deficiency (MCAD), long-chain acyl dehydrogenase deficiency (LCAD), short-chain acyld dehydrogenase deficiency (SCAD), long-chain 3-hydroxyacyl-coenzyme A (CoA) deficiency, and medium-chain 3-hydroxyacyl-CoA deficiency. - Pyruvate carboxylase deficiency. - Porphyria. - Inability to maintain adequate nutrition. - Patient or caregiver non-compliance. |
Country | Name | City | State |
---|---|---|---|
United States | Shriners Hospitals for Children - Honolulu | Honolulu | Hawaii |
Lead Sponsor | Collaborator |
---|---|
Shriners Hospitals for Children | University of Hawaii |
United States,
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* Note: There are 19 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Possible effects of the ketogenic diet | Participants on the ketogenic diet will be followed clinically with standard of care until they are 21 years of age to examine the long-term benefits or risks of the KD. | Post-ketogenic diet intervention | |
Primary | Change from baseline in core symptoms of ASD | Assess core autistic symptoms through review/analysis of responses to the following measurement instruments: Autism Diagnostic Observation Schedule - Second Edition (ADOS-2); Asperger Syndrome Diagnostic Scale (ASDS); Childhood Autism Rating Scale (CARS-2); Gilliam Autism Rating Scale (GARS-3); Social Responsiveness Scale - Second Edition (SRS-2); Diagnostic and Statistical Manual IV Text Revision (DSM-IV-TR) and DSM-V ASD criteria; standardized intelligence tests (if available, administered by child's school); and Vanderbilt ADHD Diagnostic Teacher Rating Scale Forms (Vanderbilt). | Pre- and post-ketogenic diet intervention (at baseline, and after three and six months on the ketogenic diet) | |
Secondary | Change from baseline in the number of medications used for ASD management | Assess changes through the review/analysis of self-report and medical record data. | Pre- and post-ketogenic diet intervention (at baseline, and after three and six months on the ketogenic diet) | |
Secondary | Change from baseline in the dosage of medications used for ASD management | Assess changes through the review/analysis of self-report and medical record data. | Pre- and post-ketogenic diet intervention (at baseline, and after three and six months on the ketogenic diet) | |
Secondary | Change from baseline in the number of lab tests ordered for ASD management | Assess changes through the review/analysis of self-report and medical record data. | Pre- and post-ketogenic diet intervention (at baseline, and after three and six months on the ketogenic diet) | |
Secondary | Change from baseline in the number of emergency room or hospital visits for ASD management | Assess changes through review/analysis of self-report and medical record data. | Pre- and post-ketogenic diet intervention (at baseline, and after three and six months on the ketogenic diet) | |
Secondary | Change from baseline in subject/family satisfaction with the ketogenic diet | Assess changes in subject/family satisfaction with the ketogenic diet through review/analysis of responses to a questionnaire. | Pre- and post-ketogenic diet intervention (at baseline, and after three and six months on the ketogenic diet) | |
Secondary | Change from baseline in biochemical profiles due to the ketogenic diet | Assess biochemical profile differences and changes through the analysis of serum and urine ketone levels | Pre- and post-ketogenic diet intervention (at baseline, and after three and six months on the ketogenic diet) | |
Secondary | Change from baseline in biochemical profiles due to the ketogenic diet | Assess biochemical profile differences and changes through the analysis of blood and stool (gut microbiome) specimen samples | Pre- and post-ketogenic diet intervention (at baseline, and after three and six months on the ketogenic diet) |
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