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

Primary Purpose

Refractory Epilepsy

Status
Unknown status
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
ketogenic diet
Sponsored by
Tehran University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractory Epilepsy focused on measuring refractory epilepsy,, ketogenic diet, classic ketogenic diet, seizure rate, efficacy, epilepsy

Eligibility Criteria

1 Year - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Sites / Locations

  • Tehran university of medical science, school of nutritional science and dieteticsRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

ketogenic diet

Arm Description

Ketogenic diet

Outcomes

Primary Outcome Measures

seizure rate
The information will be obtained through seizure diary

Secondary Outcome Measures

Height
Height of the participants will be assessed by stadiometer and Unit for height is cm.
Investigating side effects
Side effects will be obtained via parents' reports.
serum Triglyceride
serum Triglyceride will be assessed. Units for serum TG, is mg/dl.
Weight
Weight of the participants will be assessed by seca scale and Unit for weight is kilogram.
serum Cholesterol,
serum Cholesterol will be assessed. Units for serum Cholesterol is mg/dL.
serum LDL-Cholesterol
serum LDL-Cholesterol will be assessed. Units for serum LDL-C is mg/dL.
serum HDL-Cholesterol
serum HDL-Cholesterol will be assessed. Units for serum HDL-C is mg/dL

Full Information

First Posted
December 31, 2016
Last Updated
January 21, 2017
Sponsor
Tehran University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03031028
Brief Title
Effect of Outpatient Classic Ketogenic Diet in Epileptic Children and Adolescent.
Official Title
The Study of Outpatient Ketogenic Diet on Seizure Rate, Nutritional Status and Some Biochemical Factors in Children and Adolescent With Refractory Epilepsy.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (undefined)
Primary Completion Date
February 2017 (Anticipated)
Study Completion Date
March 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tehran University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
This research will be done to observe efficacy, safety, and tolerability of the classic ketogenic diet (CKD) on an outpatient basis without fasting, caloric and fluid restriction in children with and adolescents with intractable epilepsy. 30 children and adolescents with intractable epilepsy based on inclusion and exclusion criteria have been enrolled in the study, Investigators prescribe them classic ketogenic diet. Efficacy of the diet will be assessed through seizure rates, number of anti-epileptic drug used by the patients, and EEG changes. Seizure frequency will be assessed by seizure record diary that is filled out by family of the patients and will be compared with data that will be taken at 1, 3 months after start of the diet. EEG will be taken at baseline and 3 months after start of the diet. Patients will be reviewed at 1, 3 months after start of the diet at outpatient clinic. Intolerances and Complications will be documented at each clinic visits and via telephone calling during clinic visits intervals to evaluate tolerability and safety of the KD. For close monitoring of the complications along with blood tests and urinalysis Investigators will do echocardiography and renal ultrasound at baseline and 3 months after start of the diet. Laboratory values will be assessed at baseline and 3 months after start of the diet. Also, nutritional status and growth of children will be assessed at baseline and 1, 3 months after start of diet.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractory Epilepsy
Keywords
refractory epilepsy,, ketogenic diet, classic ketogenic diet, seizure rate, efficacy, epilepsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ketogenic diet
Arm Type
Other
Arm Description
Ketogenic diet
Intervention Type
Other
Intervention Name(s)
ketogenic diet
Intervention Description
Ketogenic Diet is a high fat, low carbohydrate diet.
Primary Outcome Measure Information:
Title
seizure rate
Description
The information will be obtained through seizure diary
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Height
Description
Height of the participants will be assessed by stadiometer and Unit for height is cm.
Time Frame
Before and after 1 and 3 months on the classical KD.
Title
Investigating side effects
Description
Side effects will be obtained via parents' reports.
Time Frame
After 3 months on the classical KD
Title
serum Triglyceride
Description
serum Triglyceride will be assessed. Units for serum TG, is mg/dl.
Time Frame
Before and after 3 months on the classical KD
Title
Weight
Description
Weight of the participants will be assessed by seca scale and Unit for weight is kilogram.
Time Frame
Before and after 1 and 3 months on the classical KD.
Title
serum Cholesterol,
Description
serum Cholesterol will be assessed. Units for serum Cholesterol is mg/dL.
Time Frame
Before and after 3 months on the classical KD
Title
serum LDL-Cholesterol
Description
serum LDL-Cholesterol will be assessed. Units for serum LDL-C is mg/dL.
Time Frame
Before and after 3 months on the classical KD.
Title
serum HDL-Cholesterol
Description
serum HDL-Cholesterol will be assessed. Units for serum HDL-C is mg/dL
Time Frame
Before and after 3 months on the classical KD

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maryam Mahmoudi, MD, PHD
Phone
00989126182883
Email
m-mahmoudi@sina.tums.ac.ir
First Name & Middle Initial & Last Name or Official Title & Degree
Mona Kavoosi, MSc student
Phone
00989123759711
Email
m_kavoosi@razi.tums.ac.ir
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maryam Mahmoudi, MD, PHD
Organizational Affiliation
Tehran university of medical science, school of Nutritional science and Dietetics
Official's Role
Study Director
Facility Information:
Facility Name
Tehran university of medical science, school of nutritional science and dietetics
City
Tehran
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maryam Mahmoudi, MD,PHD
Phone
00989126182883
Email
m-mahmoudi@sina.tums.ac.ir
First Name & Middle Initial & Last Name & Degree
Mona Kavoosi, MSc student

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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