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NCT Number: NCT03183076

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

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.

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Key information

Conditions

Epilepsy, Drug Resistant Brain Diseases Central Nervous System Diseases Drug Resistant Epilepsy Epilepsy Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Western Medical Center, Mexican Institute of Social Security

Guadalajara, Jalisco, 44340, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

modified adkins diet

Other

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 names: adkins diet in drug-resistant epilepsy

Pharmacotherapy without diet

Drug

Patients were assigned to two groups, one of them received conventional treatment with antiepileptic drugs without a special diet

Other names: treatment with antiepileptic drugs

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Instituto Mexicano del Seguro Social

Other Gov

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 9, 2017
Registry last updated
Jun 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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