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

Epilepsy Clinical Trial

Official title:

Efficacy, Tolerability and Long-Term Adherence of a Modified Ketogenic Diet (Atkins) in the Management of Pharmacoresistant Epilepsy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00188500
• Other study ID #: 05-0027-AE
• Status: Recruiting
• Phase: N/A
• First received: September 12, 2005
• Last updated: December 28, 2005
• Start date: August 2005
• Est. completion date: September 2005

Study information

• Verified date: March 2004
• Source: University Health Network, Toronto
• Contact: Nina Politzer
• Phone: 416 603-5800
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 0
• Est. completion date: September 2005
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:medically refractory partial epilepsy financial ability to pay for higher priced food

Exclusion Criteria:

• Low BMI

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsy

Intervention

Behavioral:
• atkins diet

• ability to follow low carbohydrate diet

Locations

Country	Name	City	State
Canada	Toronto Western Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	seizure reduction
Secondary	cognitive improvement