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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03425110
Enrollment
30
Registered
2018-02-07
Start date
2015-07-21
Completion date
2018-09-01
Last updated
2018-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy

Brief 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.

Interventions

Sponsors

Birmingham and Solihull Mental Health NHS Foundation Trust
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

The study will have no formal inclusion/

Exclusion criteria

as it is purely observational and it will be the clinical team's decision as to whether or not people are seen by the dietary clinic based on established dietary clinic protocols.

Design outcomes

Primary

MeasureTime frame
50% responder rateTwelve months

Countries

United Kingdom

Contacts

Primary ContactManny Bagary, Dr
m.bagary@nhs.net
Backup ContactBSMHFT MKD Service
bsmhft.modifiedketogenicdiet@nhs.net

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026