Modified Atkins Diet Treatment for Adults With Drug-resistant Epilepsy

Epilepsy Clinical Trial

Official title:

Modified Atkins Diet Treatment for Adults With Drug-resistant Epilepsy - a Controlled, Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01311440
• Other study ID #: 2010/2326 (REK)
• Status: Completed
• Phase: N/A
• First received: March 7, 2011
• Last updated: September 18, 2017
• Start date: March 2011
• Est. completion date: July 2017

Study information

• Verified date: September 2017
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: July 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Drug Resistant Epilepsy
• Epilepsies, Partial
• Epilepsy
• Epilepsy, Generalized
• Focal Epilepsy
• Generalized Epilepsy

Intervention

Other:
• Modified Atkins diet treatment
Eat a diet containing 16 grams of carbohydrates per day, maximize on fat. Assure sufficient intake of micronutrients.

Locations

Country	Name	City	State
Norway	Oslo University Hospital, The national Centre for epilepsy	Sandvika	Bærum Postterminal

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 weeks
Secondary	Change in body weight		12 weeks
Secondary	Change in standard 3-hrs EEG		12 weeks
Secondary	Change in life quality measured by validated questionnaire		12 weeks
Secondary	Change in various blood and serum measures		12 weeks
Secondary	Change in executive functions measured with validated questionnaire		12 weeks
Secondary	Change in seizure strength and severity measured by validated questionnaire		12 weeks