Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-26 @ 12:16 PM
Ignite Modification Date:
2025-12-26 @ 12:16 PM
NCT ID:
NCT00188500
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.
Study:
NCT00188500
Study Brief:
Protocol Section:
NCT00188500