- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02426047
Medium Chain Triglycerides as an Adjunct to the Modified Atkins Diet for Women With Catamenial Epilepsy
April 13, 2020 updated by: Johns Hopkins University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21287
- Johns Hopkins Hospital
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Wisconsin
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Madison, Wisconsin, United States, 53792
- University of Wisconsin Hospital & Clinics
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Modified Atkins diet plus betaquik®
Participants will continue on the modified Atkins diet (with a 20 net grams carbohydrate per day limit) and add betaquik® (a liquid emulsion of medium chain triglycerides) for 10 days per month for 5 months.
The days chosen are based on their particular catamenial pattern (there are 3 types that have been identified in the literature).
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Compliance as measured by the percent of time the participants drinks betaquik® averaged over 3 months
Time Frame: 6 months
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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.
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tolerability (10 point tolerance scale)
Time Frame: 6 months
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Secondary outcome measures will be tolerability of betaquik® based on a 10 point tolerance scale.
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6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Mackenzie C Cervenka, M.D., Johns Hopkins University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2015
Primary Completion (Actual)
January 1, 2020
Study Completion (Actual)
January 1, 2020
Study Registration Dates
First Submitted
March 10, 2015
First Submitted That Met QC Criteria
April 23, 2015
First Posted (Estimate)
April 24, 2015
Study Record Updates
Last Update Posted (Actual)
April 15, 2020
Last Update Submitted That Met QC Criteria
April 13, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00038562
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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