Clinical trial NCT02426047: Medium Chain Triglycerides as an Adjunct to the Modified Atkins Diet for Women With Catamenial Epilepsy
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epilepsy
Seizure
Catamenial Epilepsy
Medically Resistant Epilepsy
Medically Resistant Seizures
Keywords: seizures
epilepsy
catamenial
ketogenic diet
modified Atkins diet
intractable epilepsy
medically refractory epilepsy
adult
medium chain triglyceride
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Vitaflo International, Ltd
First posted: 2015-04-24
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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
* 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

Primary outcomes:
measure: Compliance as measured by the percent of time the participants drinks betaquik® averaged over 3 months
timeFrame: 6 months
Secondary outcomes:
measure: Tolerability (10 point tolerance scale)
timeFrame: 6 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Madison
country: United States
facility: University of Wisconsin Hospital & Clinics
state: Wisconsin
Study officials:
affiliation: Johns Hopkins University
name: Mackenzie C Cervenka, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kossoff EH, Rowley H, Sinha SR, Vining EP. A prospective study of the modified Atkins diet for intractable epilepsy in adults. Epilepsia. 2008 Feb;49(2):316-9. doi: 10.1111/j.1528-1167.2007.01256.x. Epub 2007 Oct 5.
citation: Herzog AG, Klein P, Ransil BJ. Three patterns of catamenial epilepsy. Epilepsia. 1997 Oct;38(10):1082-8. doi: 10.1111/j.1528-1157.1997.tb01197.x.