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| Name | Class |
|---|---|
| Vitaflo International, Ltd | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Modified Atkins diet plus betaquik® | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| betaquik® | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria (basic exclusion criteria for the modified Atkins diet, so patients should have already been screened for these factors):
Exclusion Criteria (specific to this study):
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| Name | Affiliation | Role |
|---|---|---|
| Mackenzie C Cervenka, M.D. | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States | ||
| University of Wisconsin Hospital & Clinics |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17919301 | Background | 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. | |
| 9579954 | Background | 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. |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D012640 | Seizures |
| D000069279 | Drug Resistant Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
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|
| Madison |
| Wisconsin |
| 53792 |
| United States |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |