Ketogenic Therapy Effects on Electrical and Metabolic Abnormalities in Epilepsy
Ключови думи
Резюме
Описание
The basis of Ketogenic Therapy is an altered macronutrient intake. It is based on a ratio of fat: protein+carbohydrate in which protein intake is adequate and carbohydrate is minimal. On Ketogenic Therapy, the body metabolizes fat, producing ketones as an energy source for the brain. Induction of ketosis has been shown to correlate with the reduction of seizures observed with Ketogenic Therapy. A major challenge of Ketogenic Therapy in children is that the compounds provided to stop seizure activity are the same compounds provided for growth and development. The altered macronutrient ratio that is the basis of Ketogenic Therapy is also a potential risk factor for dyslipidemia and may adversely affect growth. The investigators will evaluate efficacy of Ketogenic Therapy by assessing seizures and requirements for antiepileptic drugs. The investigators will evaluate adverse effects of Ketogenic Therapy by assessing dyslipidemia and growth. The investigators will foster optimal daily administration of therapy with structured training programs for caregivers.
Дати
Последна проверка: | 10/31/2019 |
Първо изпратено: | 08/11/2014 |
Очаквано записване подадено: | 08/11/2014 |
Първо публикувано: | 08/14/2014 |
Изпратена последна актуализация: | 11/13/2019 |
Последна актуализация публикувана: | 11/17/2019 |
Действителна начална дата на проучването: | 08/31/2006 |
Приблизителна дата на първично завършване: | 09/30/2020 |
Очаквана дата на завършване на проучването: | 09/30/2020 |
Състояние или заболяване
Интервенция / лечение
Dietary Supplement: Ketogenic Therapy
Фаза
Групи за ръце
Arm | Интервенция / лечение |
---|---|
Experimental: Ketogenic Therapy Ketogenic Therapy will be administered. | Dietary Supplement: Ketogenic Therapy Ketogenic Therapy is based on a ratio of fat: protein+carbohydrate in which protein intake is adequate, fat intake is high, and carbohydrate intake is minimal. |
Критерии за допустимост
Полове, допустими за проучване | All |
Приема здрави доброволци | Да |
Критерии | Inclusion Criteria: - Patients whose physician has prescribed the ketogenic diet - Patients with lab tests consistent with the ability to metabolize a high fat and low carbohydrate diet - Patients that can be compliant with administration of the therapy and with record keeping. Exclusion Criteria: - Patients with lab tests consistent with the inability to metabolize a high fat and low carbohydrate diet - Patients at risk of being non-compliant with administration of the therapy and with record keeping |
Резултат
Първични изходни мерки
1. Reduced seizures [2 years]
Вторични изходни мерки
1. Reduced requirement for medications [2 years]