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Modified Atkins Diet Treatment for Adults With Drug-resistant Epilepsy

NCT ID: NCT01311440

Last Updated: 2017-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2017-07-31

Brief Summary

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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

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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.

Conditions

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Epilepsy Focal Epilepsy Generalized Epilepsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Modified Atkins diet treatment

12 weeks of Modified Atkins diet treatment, recording seizures

Group Type EXPERIMENTAL

Modified Atkins diet treatment

Intervention Type OTHER

Eat a diet containing 16 grams of carbohydrates per day, maximize on fat. Assure sufficient intake of micronutrients.

No intervention

12 weeks seizure record

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Modified Atkins diet treatment

Eat a diet containing 16 grams of carbohydrates per day, maximize on fat. Assure sufficient intake of micronutrients.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Magnhild Kverneland

Registered Nutritionist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Karl Otto Nakken

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Locations

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Oslo University Hospital, The national Centre for epilepsy

Sandvika, Bærum Postterminal, Norway

Site Status

Countries

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Norway

Other Identifiers

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2010/2326 (REK)

Identifier Type: -

Identifier Source: org_study_id