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Clinical Trial: Use of the Atkins Diet for Adults with Intractable Epilepsy
This study is currently recruiting patients.
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Purpose
This is a prospective study to determine whether the Atkins diet reduces seizures, creates ketosis, and is well tolerated in adults with epilepsy. Approximately 30 patients will be enrolled, expecting 20 to complete the 6-month study. The investigators plan to establish the seizure baseline and type, initiate the Atkins diet, then monitor its administration in terms of seizure reduction, ketosis, and side effects for a 6-month period.
| Condition | Intervention |
|---|---|
| Epilepsy | Behavior: Atkins diet (15 grams/day carbohydrates) |
MedlinePlus related topics: Epilepsy
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Further Study Details:
Primary Outcomes: Seizure reduction
Secondary Outcomes: Ketosis; tolerability
Expected Total Enrollment: 30
Secondary Outcomes: Ketosis; tolerability
Expected Total Enrollment: 30
Study start: June 2004
Last follow-up: July 2005
Patients are seen in the Johns Hopkins General Clinical Research Center (GCRC) and started on a modified Atkins diet (15g/day of carbohydrates). Medications remain unchanged and labs are drawn. Followup is at 1 month, 3 months, and 6 months into the study. After 1 month, carbohydrates and medications can be altered. Ketosis (urine) is measured by patients semiweekly, weight weekly, and seizures daily and recorded on a calendar.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- Ages 18 and over
- Weekly seizures or 4 times per month
- Use of at least 2 anticonvulsant drugs
Exclusion Criteria:
- Prior use of the Atkins diet for > 1 week
- Prior use of the ketogenic diet within the past year
- Kidney, heart disease, renal disease
- Hypercholesterolemia
- Pseudoseizures
- Pregnancy
- Body mass index (BMI) below 18.5
- Status epilepticus within the past 6 months
- 2 week seizure-free period within the past 6 months
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00121927
Eric H Kossoff, MD 410-614-6054 ekossoff@jhmi.edu
Saurabh Sinha, MD sasinha@jhmi.edu
Saurabh Sinha, MD sasinha@jhmi.edu
Maryland
Johns Hopkins Hospital GCRC, Baltimore, Maryland, 21287, United States; Recruiting
Gerald Stacy 410-955-6262 gstacy@jhu.edu
Eric H Kossoff, MD, Principal Investigator
Saurabh Sinha, MD, Sub-Investigator
Eileen P Vining, MD, Sub-Investigator
Hannah Rowley, RD, Sub-Investigator
Eric H Kossoff, MD, Principal Investigator
Saurabh Sinha, MD, Sub-Investigator
Eileen P Vining, MD, Sub-Investigator
Hannah Rowley, RD, Sub-Investigator
Study chairs or principal investigators
Eric H Kossoff, MD, Principal Investigator, Johns Hopkins Medical Institutions
More Information
Publications
Kossoff EH, Krauss GL, McGrogan JR, Freeman JM. Efficacy of the Atkins diet as therapy for intractable epilepsy. Neurology. 2003 Dec 23;61(12):1789-91.
Study ID Numbers: 04-02-27-08
Record last reviewed: July 2005
Last Updated: July 22, 2005
Record first received: July 21, 2005
ClinicalTrials.gov Identifier: NCT00121927
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-07-26
Record last reviewed: July 2005
Last Updated: July 22, 2005
Record first received: July 21, 2005
ClinicalTrials.gov Identifier: NCT00121927
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-07-26
Resources
- The One Day Diet: The truth (Chase Freedom)
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