Effect of Outpatient Classic Ketogenic Diet in Epileptic Children and Adolescent.

NCT03031028 | Unknown Phase 2 DMC

• 1 other identifier: 94-03-161-30342
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study will consider the effectiveness of the ketogenic diet (high-fat, low-carbohydrate, and moderate protein) in treating epilepsy. Investigators enroll a group of eligible epileptic children and adolescent who have been referred from epilepsy center to our clinic and prescribe them ketogenic diet.

Conditions

Refractory Epilepsy

Keywords

refractory epilepsy,; ketogenic diet; classic ketogenic diet; seizure rate; efficacy; epilepsy

Outcome Measures

Primary Outcomes (1)

• seizure rate

  The information will be obtained through seizure diary

  3 months

Secondary Outcomes (7)

• Height

  Before and after 1 and 3 months on the classical KD.

• Investigating side effects

  After 3 months on the classical KD

• serum Triglyceride

  Before and after 3 months on the classical KD

• Weight

  Before and after 1 and 3 months on the classical KD.

• serum Cholesterol,

  Before and after 3 months on the classical KD

Study Arms (1)

ketogenic diet

OTHER

Ketogenic diet

Other: ketogenic diet

Interventions

ketogenic diet OTHER

Ketogenic Diet is a high fat, low carbohydrate diet.

ketogenic diet

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Ages 1-18 years,
• The patient has tried at least 3 different AED:s including one combination with two or more different AED:s.
• The parents are willing to include their child in the study after written and verbal information.
• Patients with all types of epilepsy can be included.
• The patient is submitted to our epilepsy center.

You may not qualify if:

• The patient has a medical condition, for example a metabolic disease, where ketogenic diet is contraindicated.
• The patient's nutritional status is not good enough or intake of fluid is to small to permit treatment with ketogenic diet.
• No history of hyperlipidemia
• No history of renal stones
• No previous treatment with ketogenic diet
• Beta-oxidation defects - medium-chain acyl dehydrogenase deficiency (MCAD), long-chain acyl dehydrogenase deficiency (LCAD), short-chain acyld dehydrogenase deficiency (SCAD), long-chain 3-hydroxyacyl-coenzyme A (CoA) deficiency, and medium-chain 3- hydroxyacyl-CoA deficiency.
• The family is expected to have compliance problems with treatment and/or seizure registration

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead

Study Sites (1)

Tehran university of medical science, school of nutritional science and dietetics

Tehran, Tehran Province, Iran

RECRUITING

MeSH Terms

Conditions

Drug Resistant Epilepsy; Epilepsy

Interventions

Diet, Ketogenic

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Maryam Mahmoudi, MD, PHD

  Tehran university of medical science, school of Nutritional science and Dietetics

  STUDY DIRECTOR

Central Study Contacts

Maryam Mahmoudi, MD, PHD

CONTACT

00989126182883; m-mahmoudi@sina.tums.ac.ir

Mona Kavoosi, MSc student

CONTACT

00989123759711; m_kavoosi@razi.tums.ac.ir

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2016
• First Posted: January 25, 2017
• Study Start: July 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: March 1, 2017
• Last Updated: January 25, 2017

Record last verified: 2016-09

Locations

IR (1)