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Efficacy of Modified Ketogenic Diet (Atkins) in Management of Epilepsy

Primary Purpose

Epilepsy

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
atkins diet
ability to follow low carbohydrate diet
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring epilepsy, atkins diet

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

Inclusion Criteria:medically refractory partial epilepsy financial ability to pay for higher priced food - Exclusion Criteria: Low BMI

Sites / Locations

  • Toronto Western HospitalRecruiting

Outcomes

Primary Outcome Measures

seizure reduction

Secondary Outcome Measures

cognitive improvement

Full Information

First Posted
September 12, 2005
Last Updated
December 28, 2005
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT00188500
Brief Title
Efficacy of Modified Ketogenic Diet (Atkins) in Management of Epilepsy
Official Title
Efficacy, Tolerability and Long-Term Adherence of a Modified Ketogenic Diet (Atkins) in the Management of Pharmacoresistant Epilepsy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2004
Overall Recruitment Status
Unknown status
Study Start Date
August 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University Health Network, Toronto

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to determine whether patients with uncontrolled epilepsy can follow a low carbohydrate diet long-term and if so, how will that diet affect their seizures
Detailed Description
In the management of drug-resistant epilepsy, many strategies have been examined. The Ketogenic Diet, high in fats and low in all other nutrients was observed to be of benefit. However, due to its complexedness and unpalatability, this diet is rarely used in the adult population. A recent small study showed seizure reduction with the Atkins Diet. In this study, patients will be randomized into one of 2 groups- group 1 receiving limited dietary instruction for the Atkins Diet and group 2- receiving detailed dietary instruction. A seizure severity-matched control group will also take part. We will follow these patients over a period of 2 years looking at seizure frequency, weight, sustainability of the diet, effect on anti-epilepsy medication dosage, effect in cognition, quality of life and financial impact of the diet. Patients will come to clinic to see the dietitian at specific intervals. cognitive testing will also be done at the beginning of the study and every 6 months thereafter. Patients will keep food charts, ketosis charts and seizure diaries.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
epilepsy, atkins diet

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
atkins diet
Intervention Type
Behavioral
Intervention Name(s)
ability to follow low carbohydrate diet
Primary Outcome Measure Information:
Title
seizure reduction
Secondary Outcome Measure Information:
Title
cognitive improvement

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
Inclusion Criteria:medically refractory partial epilepsy financial ability to pay for higher priced food - Exclusion Criteria: Low BMI
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nina Politzer
Phone
416 603-5800
Ext
2446
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J Martin delCampo
Organizational Affiliation
UHN
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nina Politzer, BScN
Phone
416 603-5800
Ext
2446
Email
politzer@uhnres.utoronto.ca
First Name & Middle Initial & Last Name & Degree
J. Martin delCampo, MD FRCP(C)

12. IPD Sharing Statement

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Efficacy of Modified Ketogenic Diet (Atkins) in Management of Epilepsy

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