Use of the Atkins Diet for Adults With Intractable Epilepsy

Johns Hopkins University

Status: Completed

Conditions: Epilepsy

Treatments: Behavioral: Atkins diet (15 grams/day carbohydrates)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00121927

04-02-27-08

Details and patient eligibility

About

This is a prospective study to determine whether the Atkins diet reduces seizures, creates ketosis, and is well tolerated in adults with epilepsy. Approximately 30 patients will be enrolled, expecting 20 to complete the 6-month study. The investigators plan to establish the seizure baseline and type, initiate the Atkins diet, then monitor its administration in terms of seizure reduction, ketosis, and side effects for a 6-month period.

Full description

Patients are seen in the Johns Hopkins General Clinical Research Center (GCRC) and started on a modified Atkins diet (15g/day of carbohydrates). Medications remain unchanged and labs are drawn. Followup is at 1 month, 3 months, and 6 months into the study. After 1 month, carbohydrates and medications can be altered. Ketosis (urine) is measured by patients semiweekly, weight weekly, and seizures daily and recorded on a calendar.

This study is ongoing with approximately 20 patients of 30 enrolled as of February 2006.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ages 18 and over
• Weekly seizures or 4 times per month
• Use of at least 2 anticonvulsant drugs

Exclusion criteria

• Prior use of the Atkins diet for > 1 week
• Prior use of the ketogenic diet within the past year
• Kidney, heart disease, renal disease
• Hypercholesterolemia
• Pseudoseizures
• Pregnancy
• Body mass index (BMI) below 18.5
• Status epilepticus within the past 6 months
• 2 week seizure-free period within the past 6 months

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)