Use of the Atkins Diet for Adults With Intractable Epilepsy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2007-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Epilepsy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Atkins diet (15 grams/day carbohydrates)

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No