Use of the Atkins Diet for Adults With Intractable Epilepsy

Epilepsy Clinical Trial

Official title:

Use of the Atkins Diet for Adults With Intractable Epilepsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00121927
• Other study ID #: 04-02-27-08
• Status: Completed
• Phase: N/A
• First received: July 15, 2005
• Last updated: January 26, 2010
• Start date: June 2004
• Est. completion date: June 2007

Study information

• Verified date: February 2007
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsy

Intervention

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

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital GCRC	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Center for Research Resources (NCRR)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Kossoff EH, Krauss GL, McGrogan JR, Freeman JM. Efficacy of the Atkins diet as therapy for intractable epilepsy. Neurology. 2003 Dec 23;61(12):1789-91. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seizure reduction
Secondary	Ketosis
Secondary	tolerability

External Links

•   Center website
•   Patient support network (non-medical) website