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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02426047
Other study ID # IRB00038562
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 2015
Est. completion date January 2020

Study information

Verified date April 2020
Source Johns Hopkins University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date January 2020
Est. primary completion date January 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Dietary Supplement:
betaquik®
Participants will add 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.

Locations

Country Name City State
United States Johns Hopkins Hospital Baltimore Maryland
United States University of Wisconsin Hospital & Clinics Madison Wisconsin

Sponsors (2)

Lead Sponsor Collaborator
Johns Hopkins University Vitaflo International, Ltd

Country where clinical trial is conducted

United States, 

References & Publications (2)

Herzog AG, Klein P, Ransil BJ. Three patterns of catamenial epilepsy. Epilepsia. 1997 Oct;38(10):1082-8. — View 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. Epub 2007 Oct 5. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Compliance as measured by the percent of time the participants drinks betaquik® averaged over 3 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. 6 months
Secondary Tolerability (10 point tolerance scale) Secondary outcome measures will be tolerability of betaquik® based on a 10 point tolerance scale. 6 months
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