EpilepsyNCT04646850
Long-term Treatment With the Ketogenic Diet in Epilepsy
An observational study of Epilepsy and GLUT1DS1, run by Oslo University Hospital at 1 site in Norway.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Epilepsy, GLUT1DS1, PDH Deficiency
- What is being tested?
- Color duplex ultrasound of the carotid arteries
- How many people
- 30 participants
- Where
- 1 siteNorway
- Study dates
- 6 Aug 2018to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Conditions
- Epilepsy, GLUT1DS1, PDH Deficiency
- Being tested
- Color duplex ultrasound of the carotid arteries
- Keywords
- Ketogenic dieting
- Medical subject headings
- Epilepsy, Pyruvate Dehydrogenase Complex Deficiency Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Color duplex ultrasound of the carotid arteriesOther
Examinations carried out according to the American Society of Echocardiography guidelines 25 using a Vivid 7 US instrumentation with a linear M12L probe (14 MHZ; General Electric).
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular risk after long-term treatment with the ketogenic diet
Color duplex ultrasound
Measured: 2018-2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2020
- Study start6 Aug 2018
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anette Ramm-Pettersen, Oslo University Hospital
- Investigators
- Anette Ramm-Pettersen, MD PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04646850
- Sponsor's protocol ID
- 18-14061
- Status last verified
- Oct 2022
- First submitted
- 12 Mar 2019
- Last updated
- 21 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Treatment With the Ketogenic Diet in Epilepsy and Epilepsy-related Rare Diseases
- ClinicalTrials.gov ID
- NCT04646850
- Acronym / sponsor ID
- 18-14061
- Conditions
- Epilepsy, GLUT1DS1, PDH Deficiency
- Keywords
- Ketogenic dieting
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 6 Aug 2018 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 30 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Color duplex ultrasound of the carotid arteriesExaminations carried out according to the American Society of Echocardiography guidelines 25 using a Vivid 7 US instrumentation with a linear M12L probe (14 MHZ; General Electric). | Other | – |
Primary outcome
Cardiovascular risk after long-term treatment with the ketogenic diet
Time frame: 2018-2022
Color duplex ultrasound
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anette Ramm-Pettersen, MD PhD principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy and GLUT1DS1, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular risk after long-term treatment with the ketogenic diet (time frame: 2018-2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2022.