Modified Atkins Diet Treatment for Adults With Drug-resistant Epilepsy

Sponsor

Oslo University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01311440

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Epilepsy Focal Epilepsy Generalized Epilepsy	Other: Modified Atkins diet treatment	N/A

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

Study Type:

Interventional

Actual Enrollment :

75 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Modified Atkins Diet Treatment for Adults With Drug-resistant Epilepsy - a Controlled, Randomized Trial

Actual Study Start Date :

Mar 1, 2011

Actual Primary Completion Date :

Jun 1, 2017

Actual Study Completion Date :

Jul 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Change in seizure frequency [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.

Secondary Outcome Measures

Change in body weight [12 weeks]
Change in standard 3-hrs EEG [12 weeks]
Change in life quality measured by validated questionnaire [12 weeks]
Change in various blood and serum measures [12 weeks]
Change in executive functions measured with validated questionnaire [12 weeks]
Change in seizure strength and severity measured by validated questionnaire [12 weeks]