Medium Chain Triglycerides as an Adjunct to the Modified Atkins Diet for Women With Catamenial Epilepsy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02426047|
Recruitment Status : Recruiting
First Posted : April 24, 2015
Last Update Posted : November 1, 2018
|Condition or disease||Intervention/treatment||Phase|
|Epilepsy Seizure Catamenial Epilepsy Medically Resistant Epilepsy Medically Resistant Seizures||Dietary Supplement: betaquik®||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||March 2015|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||July 2019|
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).
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.
Other Name: betaquik
- Compliance as measured by the percent of time the participants drinks betaquik® averaged over 3 months [ Time Frame: 6 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.
- Tolerability (10 point tolerance scale) [ Time Frame: 6 months ]Secondary outcome measures will be tolerability of betaquik® based on a 10 point tolerance scale.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02426047
|Contact: Mackenzie C. Cervenka, M.D.||443-287-0423 ext firstname.lastname@example.org|
|United States, Maryland|
|Johns Hopkins Hospital||Recruiting|
|Baltimore, Maryland, United States, 21287|
|Contact: Mackenzie C. Cervenka, M.D. 443-287-0423 ext 3 email@example.com|
|Sub-Investigator: Elizabeth A. Felton, M.D., Ph.D.|
|Sub-Investigator: Eric H. Kossoff, M.D.|
|Sub-Investigator: Bobbie J. Henry, R.D.|
|United States, Wisconsin|
|University of Wisconsin Hospital & Clinics||Recruiting|
|Madison, Wisconsin, United States, 53792|
|Contact: Elizabeth Felton, M.D.,Ph.D. 608-263-9578 firstname.lastname@example.org|
|Principal Investigator:||Mackenzie C Cervenka, M.D.||Johns Hopkins University|