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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Epilepsy
- Sponsor
- Johns Hopkins University
- Enrollment
- 16
- Locations
- 2
- Primary Endpoint
- Compliance as measured by the percent of time the participants drinks betaquik® averaged over 3 months
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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)
- •Exclusion Criteria (basic exclusion criteria for the modified Atkins diet, so patients should have already been screened for these factors):
- •Unwilling to restrict carbohydrates
- •Significantly underweight (BMI \<18.5)
- •Kidney disease
- •History of hypercholesterolemia (\>300 mg/dl) or hypertriglyceridemia (\>200 mg/dl)
- •Metabolic or mitochondrial disorder
- •Pregnancy
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Compliance as measured by the percent of time the participants drinks betaquik® averaged over 3 months
Time Frame: 6 months
The primary outcome measure will be compliance with betaquik® (compared to published compliance of MAD and medium chain triglyceride diets) to demonstrate feasibility. The participant will be considered compliant if they drink the required amount of betaquik® on more than 80% of the prescribed days.
Secondary Outcomes
- Tolerability (10 point tolerance scale)(6 months)