An interventional study of modified adkins diet and Pharmacotherapy without diet in Epilepsy, Drug Resistant, sponsored by Instituto Mexicano del Seguro Social. Completed at 1 site in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-06-09.
Sponsored by Instituto Mexicano del Seguro Social · Not applicable, Interventional, and Supportive care
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.
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.
1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.
This study's enrollment of 14 is below the median of 50 across 1,206 interventional studies indexed under Epilepsy.
Browse Epilepsy studies →Instituto Mexicano del Seguro Social is the lead sponsor of 124 studies on the registry; 21 are open to participants now.
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Exclusion Criteria:
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.
Other: modified adkins 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.
Drug: Pharmacotherapy without diet
Patients were assigned to two groups, one of them received modified adkins diet for treatment of drug-resistant epilepsy. 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
Also known as: adkins diet in drug-resistant epilepsy
Patients were assigned to two groups, one of them received conventional treatment with antiepileptic drugs without a special diet
Also known as: treatment with antiepileptic drugs
Frequency of epileptic seizures
Frequency of epileptic seizures measured according to the clinical criteria of therapeutic evaluation of Huttenlocher
Time frame: 3 months
Therapeutic response observed in electroencephalogram
Panic electroencephalographic criteria on the therapeutic response. Having regard to the standardization, improvement or worsening of the crisis in the electroencephalogram
Time frame: 3 months
Measurement of quality of life and decrease in seizures
Interrogate the patient with a questionnaire of refractory epilepsy drugs. And ask to the patient with this questionnaire if improved their quality of life and have decreased seizures after using the atkins diet modified.
Time frame: 3 months
Blood tests (Hematic biometry)
Take this blood test to assess the general conditions of the patient and see their levels of hemoglobin, hematocrit, leukocyte and platelet count.
Time frame: 3 months
Blood chemistry (serum electrolytes)
It will evaluate the general condition of the patient and with this test rule out the presence of electrolyte imbalance
Time frame: 3 months
liver function tests
Will be evaluated with this test levels of transaminases as can be raised by treatment anticonvulsant and see if there are any changes with the changes in the diet of patients
Time frame: 3 months
ketonuria
It will assess the levels of ketones in urine due to the change in the diet of patients with the Atkins diet
Time frame: 3 months
Plan to share: No
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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Instituto Mexicano del Seguro Social