Medium Chain Triglycerides as an Adjunct to the Modified Atkins Diet for Women With Catamenial Epilepsy

Completed · Not applicable

Conditions studied: Epilepsy, Seizure, Catamenial Epilepsy, Medically Resistant Epilepsy, Medically Resistant Seizures

In brief

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.

Key facts

Study ID

NCT02426047

Run by

Johns Hopkins University

People needed

16

Starts

2015-03-01

Expected to finish

2020-01-01

Last updated by the study team

2020-04-15

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Lactose intolerance or milk allergy
• Aversion to liquids or inability to eat solid food
• Exclusion Criteria (specific to this study):
• Men
• Women who are menopausal or peri-menopausal
• Prior use of betaquik® at any time for any duration
• Already using another ketogenic diet supplement on a sporadic basis (unless the patient is using one daily and is willing to continue doing so for the duration of this study)
• Already using coconut oil specifically for catamenial epilepsy within the month prior to enrollment (okay if patient only using for cooking throughout the month)
• Taking a hormonal contraceptive so that they do not menstruate (e.g. taking active instead of placebo oral contraceptive pills to avoid having a period)
• Anticipated need to adjust anti-epileptic medications within the next 6 months
• Anticipated initiation, change, or discontinuation of a hormonal contraceptive within the next 6 months
• Pregnant or anticipated pregnancy within the next 6 months

Where it is running

• Johns Hopkins Hospital — Baltimore, Maryland, United States
• University of Wisconsin Hospital & Clinics — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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