Efficacy, Tolerability and Adherence of the Modified Atkins Diet on Drug-resistant Epilepsy in Adults Patients
Overview
- Phase
- Not Applicable
- Intervention
- modified adkins diet
- Conditions
- Epilepsy, Drug Resistant
- Sponsor
- Instituto Mexicano del Seguro Social
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- Frequency of epileptic seizures
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
The Atkins Diet Modified (ADM) is the best alternative treatment for drug-resistant epilepsy, There is a high prevalence worldwide , especially in Latin American countries, including Mexico.
Low income earners, many of which do not have a social security, must meet the high costs by Antiepileptic Drugs (AEDS), which in addition should be used in conjunction or combination therapy, because monotherapy is insufficient .
The diet adkins makes some changes in the traditional food habits by others that are accessible and not necessarily expensive, whose mechanism allows for better control of the seizures.
Detailed Description
Objective: To assess the efficacy, tolerability and adherence of the modified adkins diet in adult patients with drug-resistent epilepsy Materials and Methods: Clinical trial, made up of patients with drug-resistent epilepsy, selected by convenience, who will be handled pharmacologically with the standard treatment of this condition for a period of not less than 6 months, after which they will be treated with adkins diet modified, prior informed consent, to establish its effect and a comparative analysis later. The objective of this work is to analyze the efficacy, tolerability and adherence of the modified atkins diet in adult patients with drug-resistant epilepsy.
Investigators
María Ingrid Alanis Guevara
MD neurologist
Instituto Mexicano del Seguro Social
Eligibility Criteria
Inclusion Criteria
- •Minimum age of 18 years
- •Patients that meet the criteria of drug-resistant epilepsy
- •Patients treated with Rational polytherapy, a minimum of 6 months, with no changes in their drug refractory condition.
- •Patients with drug- resistant epilepsy with informed consent signed by themselves and their proxy.
- •Patients with drug-resistant epilepsy of any etiology, except tumor, metabolic, degenerative or progressive.
Exclusion Criteria
- •Patients with drug-resistant epilepsy simultaneous alternate treatment to the Atkins Diet modified.
- •Patients with a neurological entity progressive and fatal
- •Patients with congenital diseases and difficulty to metabolize fats or that require high amounts of carbohydrates in the diet.
Arms & Interventions
modified adkins diet
modified adkins diet. It consists in the free intake of proteins and fats, and the restriction of carbohydrates that are gradually being installed. Its mechanism of action that induces a state of ketosis.
Intervention: modified adkins diet
Pharmacotherapy without diet
It consists in administer only pharmacological treatment withot a special diet, Drug-resistant epilepsy is characterized by the use of antiepileptic drugs and in optimal doses, depending on the type of epilepsy, at least on two consecutive occasions without response to management.
Intervention: Pharmacotherapy without diet
Outcomes
Primary Outcomes
Frequency of epileptic seizures
Time Frame: 3 months
Frequency of epileptic seizures measured according to the clinical criteria of therapeutic evaluation of Huttenlocher
Secondary Outcomes
- ketonuria(3 months)
- liver function tests(3 months)
- Therapeutic response observed in electroencephalogram(3 months)
- Measurement of quality of life and decrease in seizures(3 months)
- Blood tests (Hematic biometry)(3 months)
- Blood chemistry (serum electrolytes)(3 months)