EpilepsyNCT01311440
Modified Atkins Diet Treatment for Adults With Drug-resistant Epilepsy
A study testing Modified Atkins diet treatment in people with Epilepsy and Focal Epilepsy, run by Oslo University Hospital at 1 site in Norway.
Trial summary
In Oslo University Hospital, department of complex epilepsy, offer ketogenic diet to treat children with medically intractable epilepsy. From 2009 we added modified Atkins diet as a treatment option for children up to 18 years. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Epilepsy, Focal Epilepsy, Generalized Epilepsy
- What is being tested?
- Modified Atkins diet treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2011to Jul 2017
- Phase
- Interventional
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Focal or generalized epilepsy diagnosis
- More than 3 recordable seizures per month
- BMI > 18,5
- Not responded to at least three 3 AEDs
- 16 years or older
- Motivated to complete the diet after thorough information
- Capable of recording seizures
- Capable of preparing the diet
Who cannot join
- Hypercholesterolemia, cardiovascular disease or kidney disease
- Been on modified Atkins diet for more than one week during the last year
- Status epilepticus last six months
- epilepsy surgery or VNS implant last year
- 4 weeks continuous seizure freedom last 2 months
- PNES seizures
Show all 9Show fewer
- other disease where dietary treatment is contraindicated
- usage of drugs or supplements that may interfere with diet or AED
- being pregnant or planning pregnancy
Trial locations and contacts
1 site in 1 country.
Norway1 site
Oslo University Hospital, The national Centre for epilepsy
Sandvika, Bærum Postterminal, 1306
About this study
Official title: Modified Atkins Diet Treatment for Adults With Drug-resistant Epilepsy - a Controlled, Randomized Trial
In Oslo University Hospital, department of complex epilepsy, offer ketogenic diet to treat children with medically intractable epilepsy. From 2009 we added modified Atkins diet as a treatment option for children up to 18 years.
We now initiate an open, prospective, randomized and controlled study with the aim to test the efficacy of treatment with modified Atkins diet in adults with focal and generalized epilepsy diagnoses, in order to evaluate whether this treatment should be offered to patients on a permanent basis.
Read the detailed description
Poorly controlled epilepsy in adults affects health and quality of life in many ways. Within this heterogenous population there are individuals who are motivated for a very strict diet in order to reduce seizures.
Among adults with epilepsy 75 - 80 % are diagnosed with focal epilepsy, while 20 - 25 % have generalized onset of seizures.
We plan to include 92 patients with focal epilepsy diagnosis. Those are randomized into diet and control groups.
During the inclusion period we also treat patients with generalized epilepsy that qualify for participation, but these are not to be randomized, rather they will follow the diet group course. We assume 18 - 23 patients with generalized epilepsy will be included in the project.
- Conditions
- Epilepsy, Focal Epilepsy, Generalized Epilepsy
- Being tested
- Modified Atkins diet treatment
- Keywords
- RCT, modified Atkins diet, epilepsy, adults, ketogenic diet
- Medical subject headings
- Epilepsy, Epilepsies, Partial, Epilepsy, Generalized
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Atkins diet treatmentOther
Eat a diet containing 16 grams of carbohydrates per day, maximize on fat. Assure sufficient intake of micronutrients.
| Study group | Role | What they receive |
|---|---|---|
| Modified Atkins diet treatment | Experimental | 12 weeks of Modified Atkins diet treatment, recording seizures Receives: Other: Modified Atkins diet treatment |
| No intervention | No intervention | 12 weeks seizure record |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in seizure frequency
All participants record detailed seizure records for 12 weeks prior to the control/diet period. The diet group participants are subsequently treated with modified Atkins diet for 12 weeks, while the control group continue their normal diet and record seizures for another 12 weeks. Seizure records for each participant before and during intervention are compared.
Measured: 12 weeks
Secondary outcomes (6)
Change in body weight
Measured: 12 weeks
Change in standard 3-hrs EEG
Measured: 12 weeks
Change in life quality measured by validated questionnaire
Measured: 12 weeks
Change in various blood and serum measures
Measured: 12 weeks
Change in executive functions measured with validated questionnaire
Measured: 12 weeks
Change in seizure strength and severity measured by validated questionnaire
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionJun 2017
- Study completionJul 2017
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Magnhild Kverneland, Oslo University Hospital
- Investigators
- Karl Otto Nakken, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01311440
- Sponsor's protocol ID
- 2010/2326 (REK)
- Status last verified
- Sep 2017
- First submitted
- 7 Mar 2011
- Last updated
- 19 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Atkins Diet Treatment for Adults With Drug-resistant Epilepsy - a Controlled, Randomized Trial
- ClinicalTrials.gov ID
- NCT01311440
- Acronym / sponsor ID
- 2010/2326 (REK)
- Conditions
- Epilepsy, Focal Epilepsy, Generalized Epilepsy
- Keywords
- RCT, modified Atkins diet, epilepsy, adults, ketogenic diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Mar 2011 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 9 Mar 2011 (estimated)
- 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.
In Oslo University Hospital, department of complex epilepsy, offer ketogenic diet to treat children with medically intractable epilepsy. From 2009 we added modified Atkins diet as a treatment option for children up to 18 years.
We now initiate an open, prospective, randomized and controlled study with the aim to test the efficacy of treatment with modified Atkins diet in adults with focal and generalized epilepsy diagnoses, in order to evaluate whether this treatment should be offered to patients on a permanent basis.
Detailed description
Poorly controlled epilepsy in adults affects health and quality of life in many ways. Within this heterogenous population there are individuals who are motivated for a very strict diet in order to reduce seizures.
Among adults with epilepsy 75 - 80 % are diagnosed with focal epilepsy, while 20 - 25 % have generalized onset of seizures.
We plan to include 92 patients with focal epilepsy diagnosis. Those are randomized into diet and control groups.
During the inclusion period we also treat patients with generalized epilepsy that qualify for participation, but these are not to be randomized, rather they will follow the diet group course. We assume 18 - 23 patients with generalized epilepsy will be included in the project.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified Atkins diet treatment | Experimental | Other: Modified Atkins diet treatment12 weeks of Modified Atkins diet treatment, recording seizures |
| No intervention | No intervention | –12 weeks seizure record |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Focal or generalized epilepsy diagnosis
- More than 3 recordable seizures per month
- BMI > 18,5
- Not responded to at least three 3 AEDs
- 16 years or older
Key exclusion criteria (9 listed)
- Hypercholesterolemia, cardiovascular disease or kidney disease
- Been on modified Atkins diet for more than one week during the last year
- Status epilepticus last six months
- epilepsy surgery or VNS implant last year
- 4 weeks continuous seizure freedom last 2 months
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 |
|---|---|---|
| Modified Atkins diet treatmentEat a diet containing 16 grams of carbohydrates per day, maximize on fat. Assure sufficient intake of micronutrients. | Other | Modified Atkins diet treatment |
Primary outcome
Change in seizure frequency
Time frame: 12 weeks
All participants record detailed seizure records for 12 weeks prior to the control/diet period. The diet group participants are subsequently treated with modified Atkins diet for 12 weeks, while the control group continue their normal diet and record seizures for another 12 weeks. Seizure records for each participant before and during intervention are compared.
6 secondary outcomes
Change in body weight
Time frame: 12 weeks
Change in standard 3-hrs EEG
Time frame: 12 weeks
Change in life quality measured by validated questionnaire
Time frame: 12 weeks
Change in various blood and serum measures
Time frame: 12 weeks
Change in executive functions measured with validated questionnaire
Time frame: 12 weeks
Change in seizure strength and severity measured by validated questionnaire
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2017.
- Individual participant dataSharing planned: Undecided
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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.
Karl Otto Nakken 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?
A study testing Modified Atkins diet treatment in people with Epilepsy and Focal Epilepsy, 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 8 inclusion and 9 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: finished, as of the sponsor's last update on 19 Sep 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in seizure frequency (time frame: 12 weeks). 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 19 Sep 2017.