Internet Administration of the Modified Atkins Diet for Adults With Intractable Epilepsy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00436631|
Recruitment Status : Completed
First Posted : February 19, 2007
Last Update Posted : September 2, 2015
|Condition or disease||Intervention/treatment||Phase|
|Epilepsy||Behavioral: Dietary management of seizures||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Internet Administration of the Modified Atkins Diet for Adults With Intractable Epilepsy|
|Study Start Date :||February 2007|
|Actual Primary Completion Date :||February 2011|
|Actual Study Completion Date :||December 2011|
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.
- Seizure frequency [ Time Frame: 3 months ]
- Tolerability (ability to create and maintain ketosis), cholesterol, weight [ Time Frame: 3 months ]
- Ability to follow instructions via email (and maintain ketosis and seizure control when achieved). [ Time Frame: 3 months ]
- Ketosis (measured by urine) [ Time Frame: 3 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00436631
|United States, Maryland|
|Johns Hopkins Hospital|
|Baltimore, Maryland, United States, 21287|
|Principal Investigator:||Eric H Kossoff, MD||Johns Hopkins University|