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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. Identifier: NCT00436631
Recruitment Status : Completed
First Posted : February 19, 2007
Last Update Posted : September 2, 2015
Information provided by (Responsible Party):
Eric Kossoff, Johns Hopkins University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Epilepsy Behavioral: Dietary management of seizures Phase 3

Detailed Description:

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:

  1. Signed consent
  2. Signed note from their neurologist/primary care provider (attached)
  3. 6 months of medical records to confirm their qualification
  4. 3-day food record (can be emailed by the patient)
  5. 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures

Arm Intervention/treatment
Experimental: diet 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.

Primary Outcome Measures :
  1. Seizure frequency [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Tolerability (ability to create and maintain ketosis), cholesterol, weight [ Time Frame: 3 months ]
  2. Ability to follow instructions via email (and maintain ketosis and seizure control when achieved). [ Time Frame: 3 months ]
  3. Ketosis (measured by urine) [ Time Frame: 3 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adults aged 18 years or older.
  • Patients must consent for themselves (NOT a family member doing this).
  • Patients need to be willing to perform the induction phase of the diet.
  • Patients must have access to an email account and fax machine.
  • Persisting, countable seizures (> 1 per week or 4 times per month) despite previous treatment with two or more antiepileptic drugs.
  • Patients with coronary heart disease, cerebrovascular disease, peripheral vascular disease, atherosclerosis, prior myocardial infarctions, or renal dysfunction will be excluded.

Exclusion Criteria:

  • Patients previously exposed to the Atkins diet (for more than one week) will be excluded.
  • Patients who had tried the ketogenic diet within the past year will be excluded.
  • Patients with non-epileptic seizures (pseudoseizures) will be excluded.
  • Patients that are pregnant or become pregnant during the study will be excluded.
  • Patients must have a local English-speaking neurologist or primary care provider willing to sign a form stating they are available for any emergencies, considering some patients may be a far distance away.
  • Patients must live in the United States.
  • Patients must not have a history of status epilepticus within the past 6 months.
  • Patients with a BMI that is below 18.5 will be excluded.
  • Patients must speak and write in English.
  • Patients must be from the United States.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00436631

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United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
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Principal Investigator: Eric H Kossoff, MD Johns Hopkins University
Additional Information:
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Responsible Party: Eric Kossoff, Professor, Neurology, Johns Hopkins University Identifier: NCT00436631    
Other Study ID Numbers: NA_00008471
First Posted: February 19, 2007    Key Record Dates
Last Update Posted: September 2, 2015
Last Verified: August 2015
Keywords provided by Eric Kossoff, Johns Hopkins University:
Additional relevant MeSH terms:
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Drug Resistant Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases