Modified Atkins Diet Treatment for Adults With Drug-resistant Epilepsy

Not Applicable

Completed

• Conditions: Focal Epilepsy; Generalized Epilepsy; Epilepsy
• Interventions: Other: Modified Atkins diet treatment

• Registration Number: NCT01311440
• Lead Sponsor: Oslo University Hospital

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.

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-03-07
• Study First Submitted QC: 2011-03-07
• Study First Posted: 2011-03-09
• Primary Completion: 2017-06
• Study Completion: 2017-07
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-18
• Last Update Posted: 2017-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Modified Atkins diet treatment	Modified Atkins diet treatment	12 weeks of Modified Atkins diet treatment, recording seizures

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Oslo University Hospital, The national Centre for epilepsy; 🇳🇴 Sandvika, Bærum Postterminal, Norway