Modified Atkins Diet Treatment for Adults With Drug-resistant Epilepsy
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.
Other: Modified Atkins diet treatment
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Modified Atkins Diet Treatment for Adults With Drug-resistant Epilepsy - a Controlled, Randomized Trial|
- Change in seizure frequency [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]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.
- Change in body weight [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Change in standard 3-hrs EEG [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Change in life quality measured by validated questionnaire [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Change in various blood and serum measures [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Change in executive functions measured with validated questionnaire [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Change in seizure strength and severity measured by validated questionnaire [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||March 2011|
|Estimated Study Completion Date:||March 2016|
|Estimated Primary Completion Date:||March 2016 (Final data collection date for primary outcome measure)|
Experimental: Modified Atkins diet treatment
12 weeks of Modified Atkins diet treatment, recording seizures
Other: Modified Atkins diet treatment
Eat a diet containing 16 grams of carbohydrates per day, maximize on fat. Assure sufficient intake of micronutrients.
No Intervention: No intervention
12 weeks seizure record
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01311440
|Contact: Karl Otto Nakken, MD, PhDemail@example.com|
|Contact: Magnhild Kverneland, MSc||+4767501000 ext firstname.lastname@example.org|
|Oslo University Hospital, The national Centre for epilepsy||Recruiting|
|Sandvika, Bærum Postterminal, Norway, 1306|
|Contact: Magnhild Kverneland, MSc +4767501000 ext 1294 email@example.com|
|Principal Investigator:||Karl Otto Nakken||Oslo University Hospital|