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

NCT00436631 | Completed Phase 3

• 1 other identifier: NA_00008471
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy

Keywords

epilepsy; seizures; intractable; ketosis; ketogenic; diet

Outcome Measures

Primary Outcomes (1)

• Seizure frequency

  3 months

Secondary Outcomes (3)

• Tolerability (ability to create and maintain ketosis), cholesterol, weight

  3 months

• Ability to follow instructions via email (and maintain ketosis and seizure control when achieved).

  3 months

• Ketosis (measured by urine)

  3 months

Study Arms (1)

diet

EXPERIMENTAL

Behavioral: Dietary management of seizures

Interventions

Dietary management of seizures BEHAVIORAL

Using the high-fat, low carbohydrate modified Atkins diet - 15 grams per day initially. This is a 3-month study of this diet.

diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Related Publications (2)

• 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.

  PMID: 16499770 BACKGROUND

• 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.

  PMID: 17919301 BACKGROUND

Related Links

• Information about this approach from a parent

MeSH Terms

Conditions

Epilepsy; Seizures; Ketosis

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Eric H Kossoff, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Neurology

Study Record Dates

• First Submitted: February 16, 2007
• First Posted: February 19, 2007
• Study Start: February 1, 2007
• Primary Completion: February 1, 2011
• Study Completion: December 1, 2011
• Last Updated: September 2, 2015

Record last verified: 2015-08

Locations

US (1)