Ketogenic Diet Therapy for Autism Spectrum Disorder
Completed · Not applicable
Conditions studied: Autism Spectrum Disorder
In brief
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.
Key facts
- Study ID
- NCT02477904
- Run by
- Shriners Hospitals for Children
- People needed
- 119
- Starts
- 2015-03-01
- Expected to finish
- 2017-04-28
- Last updated by the study team
- 2019-09-20
Who can join
Age: 2 and older, up to 21. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Shriners Hospitals for Children - Honolulu — Honolulu, Hawaii, United States
Full record on ClinicalTrials.gov
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