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Efficacy, Tolerability and Adherence of the Modified Atkins Diet on Drug-resistant Epilepsy

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ClinicalTrials.gov Identifier: NCT03183076
Recruitment Status : Completed
First Posted : June 9, 2017
Last Update Posted : June 9, 2017
Sponsor:
Information provided by (Responsible Party):
María Ingrid Alanis Guevara, Instituto Mexicano del Seguro Social

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.


Condition or disease Intervention/treatment Phase
Epilepsy, Drug Resistant Other: modified adkins diet Drug: Pharmacotherapy without diet Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Clinical trial, Parallel, controled
Masking: Single (Investigator)
Masking Description: MD María Ingrid Alanis Guevara. Neurologist Hospital of the Western National Medical Center. Guadalajara. Mexico
Primary Purpose: Supportive Care
Official Title: Efficacy, Tolerability and Adherence of the Modified Atkins Diet on Drug-resistant Epilepsy in Adults Patients
Actual Study Start Date : September 1, 2015
Actual Primary Completion Date : April 30, 2016
Actual Study Completion Date : December 30, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures

Arm Intervention/treatment
Active Comparator: 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.
Other: modified adkins 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
Other Name: adkins diet in drug-resistant epilepsy

Active Comparator: 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.
Drug: Pharmacotherapy without diet
Patients were assigned to two groups, one of them received conventional treatment with antiepileptic drugs without a special diet
Other Name: treatment with antiepileptic drugs




Primary Outcome Measures :
  1. Frequency of epileptic seizures [ Time Frame: 3 months ]
    Frequency of epileptic seizures measured according to the clinical criteria of therapeutic evaluation of Huttenlocher


Secondary Outcome Measures :
  1. Therapeutic response observed in electroencephalogram [ Time Frame: 3 months ]
    Panic electroencephalographic criteria on the therapeutic response. Having regard to the standardization, improvement or worsening of the crisis in the electroencephalogram

  2. Measurement of quality of life and decrease in seizures [ Time Frame: 3 months ]
    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.

  3. Blood tests (Hematic biometry) [ Time Frame: 3 months ]
    Take this blood test to assess the general conditions of the patient and see their levels of hemoglobin, hematocrit, leukocyte and platelet count.

  4. Blood chemistry (serum electrolytes) [ Time Frame: 3 months ]
    It will evaluate the general condition of the patient and with this test rule out the presence of electrolyte imbalance

  5. liver function tests [ Time Frame: 3 months ]
    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

  6. ketonuria [ Time Frame: 3 months ]
    It will assess the levels of ketones in urine due to the change in the diet of patients with the Atkins diet



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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): NCT03183076


Locations
Mexico
Western Medical Center, Mexican Institute of Social Security
Guadalajara, Jalisco, Mexico, 44340
Sponsors and Collaborators
Instituto Mexicano del Seguro Social
Investigators
Principal Investigator: María I Alanis Instituto Mexicano del Seguro Social

Publications of Results:

Other Publications:
Responsible Party: María Ingrid Alanis Guevara, MD neurologist, Instituto Mexicano del Seguro Social
ClinicalTrials.gov Identifier: NCT03183076     History of Changes
Other Study ID Numbers: F2016-1301-72
First Posted: June 9, 2017    Key Record Dates
Last Update Posted: June 9, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by María Ingrid Alanis Guevara, Instituto Mexicano del Seguro Social:
epilepsy
Diet, Carbohydrate-Restricted
Drug Resistance

Additional relevant MeSH terms:
Epilepsy
Drug Resistant Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Anticonvulsants