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Modified Atkins Diet Treatment for Adults With Drug-resistant Epilepsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01311440
Recruitment Status : Completed
First Posted : March 9, 2011
Last Update Posted : September 19, 2017
Information provided by (Responsible Party):
Magnhild Kverneland, 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.

Condition or disease Intervention/treatment Phase
Epilepsy Focal Epilepsy Generalized Epilepsy Other: Modified Atkins diet treatment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : March 2011
Actual Primary Completion Date : June 2017
Actual Study Completion Date : July 2017

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

Primary Outcome Measures :
  1. Change in seizure frequency [ Time Frame: 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 :
  1. Change in body weight [ Time Frame: 12 weeks ]
  2. Change in standard 3-hrs EEG [ Time Frame: 12 weeks ]
  3. Change in life quality measured by validated questionnaire [ Time Frame: 12 weeks ]
  4. Change in various blood and serum measures [ Time Frame: 12 weeks ]
  5. Change in executive functions measured with validated questionnaire [ Time Frame: 12 weeks ]
  6. Change in seizure strength and severity measured by validated questionnaire [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01311440

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Oslo University Hospital, The national Centre for epilepsy
Sandvika, Bærum Postterminal, Norway, 1306
Sponsors and Collaborators
Oslo University Hospital
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Principal Investigator: Karl Otto Nakken Oslo University Hospital
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Responsible Party: Magnhild Kverneland, Registered Nutritionist, Oslo University Hospital Identifier: NCT01311440    
Other Study ID Numbers: 2010/2326 (REK)
First Posted: March 9, 2011    Key Record Dates
Last Update Posted: September 19, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Magnhild Kverneland, Oslo University Hospital:
modified Atkins diet
ketogenic diet
Additional relevant MeSH terms:
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Drug Resistant Epilepsy
Epilepsies, Partial
Epilepsy, Generalized
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases