Internet Administration of the Modified Atkins Diet for Adults With Intractable Epilepsy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Johns Hopkins University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00436631
First received: February 16, 2007
Last updated: February 23, 2011
Last verified: February 2011
  Purpose

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 Intervention Phase
Epilepsy
Behavioral: Dietary management of seizures
Phase 3

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Seizure frequency [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 30
Study Start Date: February 2007
Estimated Study Completion Date: December 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00436631

Locations
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Eric H Kossoff, MD Johns Hopkins University
  More Information

Additional Information:
Publications:
Responsible Party: Eric Kossoff, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00436631     History of Changes
Other Study ID Numbers: NA_00008471
Study First Received: February 16, 2007
Last Updated: February 23, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
epilepsy
seizures
intractable
ketosis
ketogenic
diet

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on April 15, 2014