Clinical trial NCT01311440: Modified Atkins Diet Treatment for Adults With Drug-resistant Epilepsy
Official title: Modified Atkins Diet Treatment for Adults With Drug-resistant Epilepsy - a Controlled, Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epilepsy
Focal Epilepsy
Generalized Epilepsy
Keywords: RCT
modified Atkins diet
epilepsy
adults
ketogenic diet
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2011-03-09
Enrollment: 75
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* other disease where dietary treatment is contraindicated
* usage of drugs or supplements that may interfere with diet or AED
* being pregnant or planning pregnancy

Primary outcomes:
measure: Change in seizure frequency
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in body weight
timeFrame: 12 weeks
measure: Change in standard 3-hrs EEG
timeFrame: 12 weeks
measure: Change in life quality measured by validated questionnaire
timeFrame: 12 weeks
measure: Change in various blood and serum measures
timeFrame: 12 weeks
measure: Change in executive functions measured with validated questionnaire
timeFrame: 12 weeks
measure: Change in seizure strength and severity measured by validated questionnaire
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Sandvika
country: Norway
facility: Oslo University Hospital, The national Centre for epilepsy
state: Bærum Postterminal
Study officials:
affiliation: Oslo University Hospital
name: Karl Otto Nakken
role: PRINCIPAL_INVESTIGATOR
References: