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

Primary Purpose

Epilepsy, Drug Resistant

Status

Completed

Phase

Not Applicable

Locations

Mexico

Study Type

Interventional

Intervention

modified adkins diet

Pharmacotherapy without diet

About this trial

This is an interventional supportive care trial for Epilepsy, Drug Resistant focused on measuring epilepsy, Diet, Carbohydrate-Restricted, Drug Resistance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Western Medical Center, Mexican Institute of Social Security

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

modified adkins diet

Pharmacotherapy without diet

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Frequency of epileptic seizures

Frequency of epileptic seizures measured according to the clinical criteria of therapeutic evaluation of Huttenlocher

Secondary Outcome Measures

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

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.

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.

Blood chemistry (serum electrolytes)

It will evaluate the general condition of the patient and with this test rule out the presence of electrolyte imbalance

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

ketonuria

It will assess the levels of ketones in urine due to the change in the diet of patients with the Atkins diet

Full Information

NCT ID

NCT03183076

First Posted

May 31, 2017

Last Updated

June 8, 2017

Sponsor

Instituto Mexicano del Seguro Social

1. Study Identification

Unique Protocol Identification Number

NCT03183076

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Completed

Study Start Date

September 1, 2015 (Actual)

Primary Completion Date

April 30, 2016 (Actual)

Study Completion Date

December 30, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Instituto Mexicano del Seguro Social

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Epilepsy, Drug Resistant

Keywords

epilepsy, Diet, Carbohydrate-Restricted, Drug Resistance

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Clinical trial, Parallel, controled

Masking

Investigator

Masking Description

MD María Ingrid Alanis Guevara. Neurologist Hospital of the Western National Medical Center. Guadalajara. Mexico

Allocation

Randomized

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

modified adkins diet

Arm Type

Active Comparator

Arm Description

Arm Title

Pharmacotherapy without diet

Arm Type

Active Comparator

Arm Description

Intervention Type

Other

Intervention Name(s)

modified adkins diet

Other Intervention Name(s)

adkins diet in drug-resistant epilepsy

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Pharmacotherapy without diet

Other Intervention Name(s)

treatment with antiepileptic drugs

Intervention Description

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

Primary Outcome Measure Information:

Title

Frequency of epileptic seizures

Description

Frequency of epileptic seizures measured according to the clinical criteria of therapeutic evaluation of Huttenlocher

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Therapeutic response observed in electroencephalogram

Description

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

Title

Measurement of quality of life and decrease in seizures

Description

Time Frame

3 months

Title

Blood tests (Hematic biometry)

Description

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

Title

Blood chemistry (serum electrolytes)

Description

It will evaluate the general condition of the patient and with this test rule out the presence of electrolyte imbalance

Time Frame

3 months

Title

liver function tests

Description

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

Title

ketonuria

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

María I Alanis

Organizational Affiliation

Instituto Mexicano del Seguro Social

Official's Role

Principal Investigator

Facility Information:

Facility Name

Western Medical Center, Mexican Institute of Social Security

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44340

Country

Mexico

12. IPD Sharing Statement

Plan to Share IPD

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

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