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Modified Atkins Diet Treatment for Adults With Drug-resistant Epilepsy

Primary Purpose

Epilepsy, Focal Epilepsy, Generalized Epilepsy

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Modified Atkins diet treatment
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring RCT, modified Atkins diet, epilepsy, adults, ketogenic diet

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Oslo University Hospital, The national Centre for epilepsy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Modified Atkins diet treatment

No intervention

Arm Description

12 weeks of Modified Atkins diet treatment, recording seizures

12 weeks seizure record

Outcomes

Primary Outcome Measures

Change in seizure frequency
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
Change in standard 3-hrs EEG
Change in life quality measured by validated questionnaire
Change in various blood and serum measures
Change in executive functions measured with validated questionnaire
Change in seizure strength and severity measured by validated questionnaire

Full Information

First Posted
March 7, 2011
Last Updated
September 18, 2017
Sponsor
Oslo University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01311440
Brief Title
Modified Atkins Diet Treatment for Adults With Drug-resistant Epilepsy
Official Title
Modified Atkins Diet Treatment for Adults With Drug-resistant Epilepsy - a Controlled, Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
March 2011 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Focal Epilepsy, Generalized Epilepsy
Keywords
RCT, modified Atkins diet, epilepsy, adults, ketogenic diet

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Modified Atkins diet treatment
Arm Type
Experimental
Arm Description
12 weeks of Modified Atkins diet treatment, recording seizures
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
12 weeks seizure record
Intervention Type
Other
Intervention Name(s)
Modified Atkins diet treatment
Intervention Description
Eat a diet containing 16 grams of carbohydrates per day, maximize on fat. Assure sufficient intake of micronutrients.
Primary Outcome Measure Information:
Title
Change in seizure frequency
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in body weight
Time Frame
12 weeks
Title
Change in standard 3-hrs EEG
Time Frame
12 weeks
Title
Change in life quality measured by validated questionnaire
Time Frame
12 weeks
Title
Change in various blood and serum measures
Time Frame
12 weeks
Title
Change in executive functions measured with validated questionnaire
Time Frame
12 weeks
Title
Change in seizure strength and severity measured by validated questionnaire
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karl Otto Nakken
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo University Hospital, The national Centre for epilepsy
City
Sandvika
State/Province
Bærum Postterminal
ZIP/Postal Code
1306
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Modified Atkins Diet Treatment for Adults With Drug-resistant Epilepsy

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