Internet Administration of the Modified Atkins Diet for Adults With Intractable Epilepsy
This is a prospective, open-label (no control or blind) study to continue to determine whether the modified Atkins diet reduces seizures, creates ketosis, and is well tolerated in adults (not children) with epilepsy. This study will enroll and manage patients via email, phone, and fax and without dietitian involvement (primary difference from previous studies). It is a 3 month study.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Internet Administration of the Modified Atkins Diet for Adults With Intractable Epilepsy|
- Seizure frequency [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Tolerability (ability to create and maintain ketosis), cholesterol, weight [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
- Ability to follow instructions via email (and maintain ketosis and seizure control when achieved). [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Ketosis (measured by urine) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
|Study Start Date:||February 2007|
|Study Completion Date:||December 2011|
|Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
Behavioral: Dietary management of seizures
Using the high-fat, low carbohydrate modified Atkins diet - 15 grams per day initially. This is a 3-month study of this diet.
Patients will have contacted either Dr. Kossoff or Dr. Cervenka either via referral or self-referral.
Inclusion: over 18 years of age, at least weekly seizures (or 4 per month), tried at least 2 medications for your seizures, have email and fax access, are not very underweight or have high cholesterol, have not had status epilepticus (seizure lasting over 30 minutes) in the past 6 months, and have not tried the Atkins diet before or the ketogenic diet within the past year. All patients will need to have a local primary care doctor or neurologist willing to be available in case of emergencies. You and your local physician both need to speak and write in English and patients MUST be in the United States to participate. The patient (NOT a caregiver) must be the person to email the investigators - a family member cannot be the contact person.
If the patient agrees, we will send and they will fax back within 2 weeks:
- Signed consent
- Signed note from their neurologist/primary care provider (attached)
- 6 months of medical records to confirm their qualification
- 3-day food record (can be emailed by the patient)
- Labs (CBC, CMP, fasting lipid profile, urine calcium, urine creatinine, urine hcG (if female) (form attached)
After that, we will send information on how to do the diet via email, they will maintain monthly calendars, and after 3 months we will decide if the diet is helpful. After that time point, they can continue it on their own with periodic followup with either us or their local neurologist.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00436631
|United States, Maryland|
|Johns Hopkins Hospital|
|Baltimore, Maryland, United States, 21287|
|Principal Investigator:||Eric H Kossoff, MD||Johns Hopkins University|