- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04646850
Long-term Treatment With the Ketogenic Diet in Epilepsy
October 20, 2022 updated by: Anette Ramm-Pettersen, Oslo University Hospital
Long-term Treatment With the Ketogenic Diet in Epilepsy and Epilepsy-related Rare Diseases
This study will provide a comprehensive assessment of long-term treatment with the ketogenic diet, a medical diet with high fat and low carbohydrate intake, focusing on safety and cardiovascular implications.
We will assess patients with epilepsy or one of two rare metabolic diseases; glucose transporter type 1 deficiency syndrome (GLUT1 DS) or pyruvate dehydrogenase complex deficiency (PDHD).
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Oslo, Norway
- Oslo University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients treated with the ketogenic diet (classical or modified) for epilepsy, GLUT1 deficiency or PDHD at The National Centre for Epilepsy - SSE for 5 years or longer.
Description
Inclusion Criteria:
- Treatment with the ketogenic diet at the National Centre for Epilepsy (SSE) for 5 years or more
- Able to travel from The National Centre for Epilepsy - SSE (Sandvika) to Rikshospitalet (Gaustad) to perform procedures to investigate cardiovascular risk factors
- Willing to draw extra blood for research purposes
- Willing to sign informed consent and participate in the study in accordance with the study protocol
- Willing to sign informed consent for blood samples to be included in research biobank at the Department of Neurology, Oslo University Hospital
Exclusion Criteria:
- Non-compliance with the dietary treatment for 6 months or longer or more than once per month
- Not possible to communicate with parents in Norwegian or English without interpreter
- Patient not able to cooperate and lie still for about ten minutes during the carotid ultrasound examination
- Psychiatric/mental illness, alcohol or drug abuse or other factors making it impossible to pursue the study protocol
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cardiovascular risk after long-term treatment with the ketogenic diet
Time Frame: 2018-2022
|
Color duplex ultrasound
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2018-2022
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Anette Ramm-Pettersen, MD PhD, Oslo University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 6, 2018
Primary Completion (Anticipated)
December 31, 2022
Study Completion (Anticipated)
December 31, 2025
Study Registration Dates
First Submitted
March 12, 2019
First Submitted That Met QC Criteria
November 26, 2020
First Posted (Actual)
November 30, 2020
Study Record Updates
Last Update Posted (Actual)
October 21, 2022
Last Update Submitted That Met QC Criteria
October 20, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Metabolic Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Genetic Diseases, Inborn
- Genetic Diseases, X-Linked
- Carbohydrate Metabolism, Inborn Errors
- Metabolism, Inborn Errors
- Mental Retardation, X-Linked
- Intellectual Disability
- Heredodegenerative Disorders, Nervous System
- Brain Diseases, Metabolic
- Mitochondrial Diseases
- Brain Diseases, Metabolic, Inborn
- Pyruvate Metabolism, Inborn Errors
- Epilepsy
- Pyruvate Dehydrogenase Complex Deficiency Disease
Other Study ID Numbers
- 18-14061
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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