NCT00121927

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2004

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 15, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 21, 2005

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

January 27, 2010

Status Verified

February 1, 2007

First QC Date

July 15, 2005

Last Update Submit

January 26, 2010

Conditions

Epilepsy

Keywords

intractableketogenicketosisAtkins

Outcome Measures

Primary Outcomes (1)

  • Seizure reduction

Secondary Outcomes (2)

  • Ketosis

  • tolerability

Interventions

Atkins diet (15 grams/day carbohydrates)BEHAVIORAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ages 18 and over
  • Weekly seizures or 4 times per month
  • Use of at least 2 anticonvulsant drugs

You may not qualify if:

  • 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
  • week seizure-free period within the past 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Hospital GCRC

Baltimore, Maryland, 21287, United States

Location

Related Publications (1)

  • 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. doi: 10.1212/01.wnl.0000098889.35155.72.

    PMID: 14694049BACKGROUND

Related Links

MeSH Terms

Conditions

EpilepsyKetosis

Interventions

Diet, High-Protein Low-Carbohydrate

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesAcidosisAcid-Base ImbalanceMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-RestrictedDiet TherapyNutrition TherapyTherapeuticsDiet, High-ProteinDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Eric H Kossoff, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 15, 2005

First Posted

July 21, 2005

Study Start

June 1, 2004

Study Completion

June 1, 2007

Last Updated

January 27, 2010

Record last verified: 2007-02

Locations

US(1)