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

NCT03183076 | Completed DMC

• 1 other identifier: F2016-1301-72
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy, Drug Resistant

Keywords

epilepsy; Diet, Carbohydrate-Restricted; Drug Resistance

Outcome Measures

Primary Outcomes (1)

• Frequency of epileptic seizures

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

  3 months

Secondary Outcomes (6)

• Therapeutic response observed in electroencephalogram

  3 months

• Measurement of quality of life and decrease in seizures

  3 months

• Blood tests (Hematic biometry)

  3 months

• Blood chemistry (serum electrolytes)

  3 months

• liver function tests

  3 months

Study Arms (2)

modified adkins diet

ACTIVE COMPARATOR

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

Pharmacotherapy without diet

ACTIVE COMPARATOR

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

Interventions

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

Also known as: adkins diet in drug-resistant epilepsy

modified adkins diet

Pharmacotherapy without diet DRUG

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

Pharmacotherapy without diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto Mexicano del Seguro Social: lead

Study Sites (1)

Western Medical Center, Mexican Institute of Social Security

Guadalajara, Jalisco, 44340, Mexico

Location

Related Publications (30)

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  PMID: 32588435 DERIVED

MeSH Terms

Conditions

Drug Resistant Epilepsy; Epilepsy

Interventions

Drug Therapy; Diet; Therapeutics; Anticonvulsants

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Central Nervous System Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• María I Alanis

  Instituto Mexicano del Seguro Social

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: MD María Ingrid Alanis Guevara. Neurologist Hospital of the Western National Medical Center. Guadalajara. Mexico
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD neurologist

Model Details: Clinical trial, Parallel, controled

Study Record Dates

• First Submitted: May 31, 2017
• First Posted: June 9, 2017
• Study Start: September 1, 2015
• Primary Completion: April 30, 2016
• Study Completion: December 30, 2016
• Last Updated: June 9, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)