Medium Chain Triglycerides as an Adjunct to the Modified Atkins Diet for Women With Catamenial Epilepsy
| Status: | Recruiting |
|---|---|
| Conditions: | Neurology, Neurology, Epilepsy |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/13/2019 |
| Start Date: | March 2015 |
| End Date: | July 2019 |
| Contact: | Mackenzie C. Cervenka, M.D. |
| Email: | mcerven1@jhmi.edu |
| Phone: | 443-287-0423 |
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
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.
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.
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
We found this trial at
2
sites
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600 Highland Ave
Madison, Wisconsin 53792
Madison, Wisconsin 53792
(608) 263-6400
Phone: 608-263-9578
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