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

March 7, 2011
October 10, 2012
March 2011
March 2016   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01311440 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Modified Atkins Diet Treatment for Adults With Drug-resistant Epilepsy
Modified Atkins Diet Treatment for Adults With Drug-resistant Epilepsy - a Controlled, Randomized Trial

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Epilepsy
  • Focal Epilepsy
  • Generalized Epilepsy
Other: Modified Atkins diet treatment
Eat a diet containing 16 grams of carbohydrates per day, maximize on fat. Assure sufficient intake of micronutrients.
  • Experimental: Modified Atkins diet treatment
    12 weeks of Modified Atkins diet treatment, recording seizures
    Intervention: Other: Modified Atkins diet treatment
  • No Intervention: No intervention
    12 weeks seizure record
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
92
March 2016
March 2016   (final data collection date for primary outcome measure)

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
Both
16 Years and older
No
Contact: Karl Otto Nakken, MD, PhD +4767501000 karln@ous-hf.no
Contact: Magnhild Kverneland, MSc +4767501000 ext 1294 magnhild.kverneland@ous-hf.no
Norway
 
NCT01311440
2010/2326 (REK)
No
Magnhild Kverneland, Oslo University Hospital
Oslo University Hospital
Not Provided
Principal Investigator: Karl Otto Nakken Oslo University Hospital
Oslo University Hospital
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP