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

Epilepsy, Drug Resistant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03183076
• Other study ID #: F2016-1301-72
• Status: Completed
• Phase: N/A
• First received: May 31, 2017
• Last updated: June 8, 2017
• Start date: September 1, 2015
• Est. completion date: December 30, 2016

Study information

• Verified date: May 2017
• Source: Instituto Mexicano del Seguro Social
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 30, 2016
• Est. primary completion date: April 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Drug Resistant Epilepsy
• Epilepsy
• Epilepsy, Drug Resistant

Intervention

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

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

Locations

Country	Name	City	State
Mexico	Western Medical Center, Mexican Institute of Social Security	Guadalajara	Jalisco

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Mexicano del Seguro Social

Country where clinical trial is conducted

Mexico, 

References & Publications (29)

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* Note: There are 29 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of epileptic seizures	Frequency of epileptic seizures measured according to the clinical criteria of therapeutic evaluation of Huttenlocher	3 months
Secondary	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	3 months
Secondary	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.	3 months
Secondary	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.	3 months
Secondary	Blood chemistry (serum electrolytes)	It will evaluate the general condition of the patient and with this test rule out the presence of electrolyte imbalance	3 months
Secondary	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	3 months
Secondary	ketonuria	It will assess the levels of ketones in urine due to the change in the diet of patients with the Atkins diet	3 months