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Modified Atkins Diet Treatment for Adults With Drug-resistant Epilepsy

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Oslo University Hospital
Sponsor:
Information provided by (Responsible Party):
Magnhild Kverneland, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01311440
First received: March 7, 2011
Last updated: October 10, 2012
Last verified: October 2012
  Purpose

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 Intervention Phase
Epilepsy
Focal Epilepsy
Generalized Epilepsy
Other: Modified Atkins diet treatment
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Modified Atkins Diet Treatment for Adults With Drug-resistant Epilepsy - a Controlled, Randomized Trial

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Change in seizure frequency [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change in standard 3-hrs EEG [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change in life quality measured by validated questionnaire [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change in various blood and serum measures [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change in executive functions measured with validated questionnaire [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change in seizure strength and severity measured by validated questionnaire [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 92
Study Start Date: March 2011
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01311440

Contacts
Contact: Karl Otto Nakken, MD, PhD +4767501000 karln@ous-hf.no
Contact: Magnhild Kverneland, MSc +4767501000 ext 1294 magnhild.kverneland@ous-hf.no

Locations
Norway
Oslo University Hospital, The national Centre for epilepsy Recruiting
Sandvika, Bærum Postterminal, Norway, 1306
Contact: Magnhild Kverneland, MSc    +4767501000 ext 1294    magnhild.kverneland@ous-hf.no   
Sponsors and Collaborators
Oslo University Hospital
Investigators
Principal Investigator: Karl Otto Nakken Oslo University Hospital
  More Information

No publications provided

Responsible Party: Magnhild Kverneland, Registered Nutritionist, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01311440     History of Changes
Other Study ID Numbers: 2010/2326 (REK)
Study First Received: March 7, 2011
Last Updated: October 10, 2012
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Oslo University Hospital:
RCT
modified Atkins diet
epilepsy
adults
ketogenic diet

Additional relevant MeSH terms:
Epilepsies, Partial
Epilepsy
Epilepsy, Generalized
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on November 24, 2014