Ketogenic Diet Program for Epilepsy

Completed · Not applicable

Conditions studied: Epilepsy

In brief

This study will assess the effectiveness of the ketogenic diet (high-fat, low-carbohydrate, and moderate protein) in treating epilepsy. Two study groups will be comprised of children with epilepsy (0-18 years of age) and whether or not they receive the ketogenic diet - epilepsy/ketogenic diet and epilepsy/non-ketogenic diet.

Key facts

Study ID

NCT02497105

Run by

Shriners Hospitals for Children

People needed

30

Starts

2015-01-01

Expected to finish

2018-01-19

Last updated by the study team

2019-09-20

Who can join

Age: 1 and older, up to 18. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Ages 0-18 years.
• Primary diagnosis of epilepsy.
• 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.
• 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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