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

Primary Purpose

Epilepsy

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Dietary management of seizures
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring epilepsy, seizures, intractable, ketosis, ketogenic, diet

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Johns Hopkins Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

diet

Arm Description

Outcomes

Primary Outcome Measures

Seizure frequency

Secondary Outcome Measures

Tolerability (ability to create and maintain ketosis), cholesterol, weight
Ability to follow instructions via email (and maintain ketosis and seizure control when achieved).
Ketosis (measured by urine)

Full Information

First Posted
February 16, 2007
Last Updated
August 31, 2015
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT00436631
Brief Title
Internet Administration of the Modified Atkins Diet for Adults With Intractable Epilepsy
Official Title
Internet Administration of the Modified Atkins Diet for Adults With Intractable Epilepsy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johns Hopkins University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
epilepsy, seizures, intractable, ketosis, ketogenic, diet

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
diet
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Dietary management of seizures
Intervention Description
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 Measure Information:
Title
Seizure frequency
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Tolerability (ability to create and maintain ketosis), cholesterol, weight
Time Frame
3 months
Title
Ability to follow instructions via email (and maintain ketosis and seizure control when achieved).
Time Frame
3 months
Title
Ketosis (measured by urine)
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric H Kossoff, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16499770
Citation
Kossoff EH, McGrogan JR, Bluml RM, Pillas DJ, Rubenstein JE, Vining EP. A modified Atkins diet is effective for the treatment of intractable pediatric epilepsy. Epilepsia. 2006 Feb;47(2):421-4. doi: 10.1111/j.1528-1167.2006.00438.x.
Results Reference
background
PubMed Identifier
17919301
Citation
Kossoff EH, Rowley H, Sinha SR, Vining EP. A prospective study of the modified Atkins diet for intractable epilepsy in adults. Epilepsia. 2008 Feb;49(2):316-9. doi: 10.1111/j.1528-1167.2007.01256.x. Epub 2007 Oct 5.
Results Reference
background
Links:
URL
http://www.atkinsforseizures.com
Description
Information about this approach from a parent

Learn more about this trial

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

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