The Feasibility and Tolerability of Medium Chain Triglycerides as an Adjunct to the Dietary Management of Epilepsy in Women With a Catamenial Seizure Pattern on the Modified Atkins Diet

Status: Completed
Location: See all (2) locations...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The modified Atkins diet (MAD) has been shown to be effective in treating intractable epilepsy. Approximately 55% of the patients started on the diet are women of childbearing age and women with epilepsy often have a pattern of seizures that correlates with their menstrual cycle, called catamenial epilepsy. The investigators have observed that despite an overall reduction in seizure frequency, some women on the MAD continue to have breakthrough seizures in a catamenial pattern. The investigators hypothesize that women with a history of intractable epilepsy who have been on the modified Atkins diet for at least 3 months and have a catamenial seizure pattern will tolerate and be compliant with the addition of a daily amount of betaquik® (a liquid emulsion of medium chain triglycerides) for a 10 day time interval starting 2 days prior to and encompassing the primary catamenial pattern.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• Adult women ≥ 18 years

• Already on the modified Atkins diet for at least 3 months and compliant with treatment

• Catamenial seizure pattern (by Herzog criteria) for at least 2 of the past 3 months (as documented by calendars provided with annotations for seizures and menstrual cycle start and end dates)

Locations
United States
Maryland
Johns Hopkins Hospital
Baltimore
Wisconsin
University of Wisconsin Hospital & Clinics
Madison
Time Frame
Start Date: 2015-03
Completion Date: 2020-01
Participants
Target number of participants: 16
Treatments
Experimental: Modified Atkins diet plus betaquik®
Participants will continue on the modified Atkins diet (with a 20 net grams carbohydrate per day limit) and add betaquik® (a liquid emulsion of medium chain triglycerides) for 10 days per month for 5 months. The days chosen are based on their particular catamenial pattern (there are 3 types that have been identified in the literature).
Authors
Sponsors
Collaborators: Vitaflo International, Ltd
Leads: Johns Hopkins University

This content was sourced from clinicaltrials.gov