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

NCT ID: NCT00188500

Last Updated: 2005-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2005-09-30

Brief Summary

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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

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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.

Conditions

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Epilepsy

Keywords

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epilepsy atkins diet

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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atkins diet

Intervention Type BEHAVIORAL

ability to follow low carbohydrate diet

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

* Low BMI
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Principal Investigators

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J Martin delCampo

Role: PRINCIPAL_INVESTIGATOR

UHN

Locations

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Toronto Western Hospital

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Nina Politzer

Role: CONTACT

Phone: 416 603-5800

Facility Contacts

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Nina Politzer, BScN

Role: primary

Other Identifiers

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05-0027-AE

Identifier Type: -

Identifier Source: org_study_id