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Completed

NCT Number: NCT00121927

Use of the Atkins Diet for Adults With Intractable Epilepsy

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.

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Key information

Conditions

Epilepsy Acid-Base Imbalance Acidosis Brain Diseases Central Nervous System Diseases Ketosis Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Hospital GCRC

Baltimore, Maryland, 21287, United States

About this study

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.

This study is ongoing with approximately 20 patients of 30 enrolled as of February 2006.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Atkins diet (15 grams/day carbohydrates)

Behavioral

Primary outcomes

  1. Seizure reduction

Secondary outcomes

  1. Ketosis

  2. tolerability

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Center for Research Resources (NCRR)

Registry information

Important dates

Study start
2004
Study completion
2007
First posted
Jul 21, 2005
Registry last updated
Jan 27, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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