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Use of the Atkins Diet for Children With Intractable Epilepsy: A Comparison of Daily Carbohydrate Limits

Primary Purpose

Epilepsy

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Modified Atkins diet
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring Epilepsy, Ketosis, Atkins, seizures

Eligibility Criteria

3 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Ages 3-18 Daily seizures or 7 per week Failed at least 2 anticonvulsants Exclusion Criteria: Prior use of the Atkins diet for over 1 week Significant heart, liver, or kidney disease

Sites / Locations

  • Johns Hopkins Hospital

Outcomes

Primary Outcome Measures

Seizure control
Ketosis

Secondary Outcome Measures

Tolerability
Safety - cholesterol, kidney function, weight

Full Information

First Posted
September 10, 2005
Last Updated
March 26, 2009
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT00181090
Brief Title
Use of the Atkins Diet for Children With Intractable Epilepsy: A Comparison of Daily Carbohydrate Limits
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Johns Hopkins University

4. Oversight

5. Study Description

Brief Summary
This study is designed to further investigate the use of a modified Atkins diet for children with intractable, daily seizures. It is a follow-up to a study recently completed by our institution. In this 6-month study, children will be randomized to either 10 or 20 grams of carbohydrate per day, then crossed over to the opposite amount at 3 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Epilepsy, Ketosis, Atkins, seizures

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Modified Atkins diet
Primary Outcome Measure Information:
Title
Seizure control
Time Frame
6 months
Title
Ketosis
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Tolerability
Time Frame
6 months
Title
Safety - cholesterol, kidney function, weight
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ages 3-18 Daily seizures or 7 per week Failed at least 2 anticonvulsants Exclusion Criteria: Prior use of the Atkins diet for over 1 week Significant heart, liver, or kidney disease
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
14694049
Citation
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.
Results Reference
background
Links:
URL
http://www.atkinsforseizures.com
Description
Family and patient created website for study patients

Learn more about this trial

Use of the Atkins Diet for Children With Intractable Epilepsy: A Comparison of Daily Carbohydrate Limits

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