NCT03425110

The Modified Ketogenic Diet for the Treatment of Pharmacoresistant Epilepsy in Adults

The Modified Ketogenic Diet for the Treatment of Pharmacoresistant Epilepsy in Adults: an Observational Cohort Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: Birmingham and Solihull Mental Health NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The Modified Ketogenic Diet for the Treatment of Pharmacoresistant Epilepsy in Adults: an Observational Cohort Study

Detailed description

Epilepsy is a common neurological condition. Unfortunately, just over 30% of patients with epilepsy (PWE) do not become seizure free with anti-epileptic drugs. Some patients may be suitable for epilepsy surgery. Alternative established treatments include vagal nerve stimulation and the ketogenic diet in children. The evidence base for the use of ketogenic diet in adults is limited. There are a few prospective studies and no randomised control trial to date. This study is a prospective observational cohort study for adult patients with drug resistant epilepsy who are not suitable for resective epilepsy surgery. The intervention is a modified ketogenic diet. The carbohydrate load will be between 20-30gm per day. Blood ketones and blood sugars will be monitored. The primary outcome measure is seizure frequency at 12 months. There are a number of secondary outcome measures including tolerability, seizure severity, quality of life, lipid profiles and health care utilisation.

Conditions

• Epilepsy

Interventions

Type	Name	Description
OTHER	Modified Ketogenic Diet

Timeline

• Start date: 2015-07-21
• Primary completion: 2018-06-30
• Completion: 2018-09-01
• First posted: 2018-02-07
• Last updated: 2018-02-09

Locations

1 site across 1 country: United Kingdom