Modified Atkins Diet Treatment for Adults With Drug-resistant Epilepsy

University of Oslo (UIO)

Status: Completed

Conditions: Generalized Epilepsy; Epilepsy; Focal Epilepsy

Treatments: Other: Modified Atkins diet treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT01311440

2010/2326 (REK)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 2 patient groups

Modified Atkins diet treatment

Experimental group

Description:

12 weeks of Modified Atkins diet treatment, recording seizures

Treatment:

Other: Modified Atkins diet treatment

No intervention

No Intervention group

Description:

12 weeks seizure record