An interventional study of Modified Atkins diet treatment in Epilepsy, Focal Epilepsy and Generalized Epilepsy, sponsored by Oslo University Hospital. Completed at 1 site in Norway. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2017-09-19.
Sponsored by Oslo University Hospital · Not applicable, Interventional, and Treatment
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.
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.
1,848 studies on the registry are indexed under Epilepsy; 422 are open to participants now.
This study's enrollment of 75 is above the median of 50 across 1,239 interventional studies indexed under Epilepsy.
Browse Epilepsy studies →Oslo University Hospital is the lead sponsor of 834 studies on the registry; 149 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
12 weeks of Modified Atkins diet treatment, recording seizures
Other: Modified Atkins diet treatment
12 weeks seizure record
Eat a diet containing 16 grams of carbohydrates per day, maximize on fat. Assure sufficient intake of micronutrients.
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.
Time frame: 12 weeks
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
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Mar 2011 to primary completion in Jun 2017, 75 months.
Of 337 non-industry interventional studies with no phase under Epilepsy, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 77. This study's 75 months is above that.
Counting every sponsor, half of 358 studies reached it within 42 months; a quarter within 19 and three quarters within 77.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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