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Dietary Therapy in Children With Refractory Epilepsy

Primary Purpose

Epilepsy

Status

Completed

Phase

Phase 2

Locations

India

Study Type

Interventional

Intervention

Ketogenic diet (2.5 to 4:1)

Modified Atkin's diet

About this trial

This is an interventional treatment trial for Epilepsy

Eligibility Criteria

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

Inclusion Criteria:

Children aged 1-18 years with refractory epilepsy*
Willing to come for regular follow up
No motivational or psychosocial issues in the family which would preclude compliance with the diet

Exclusion Criteria

Surgically remediable cause for refractory epilepsy
Suspected mitochondrial disorder or diagnosed with a disorder in which high fat diet is contraindicated
Previously received ketogenic diet or modified Atkins diet
Chronic systemic disease like chronic kidney disease, chronic liver disease, heart disease (congenital and acquired) and chronic respiratory illness

Sites / Locations

All India Institute of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

ketogenic diet

Modifid Atkin's diet

Arm Description

ketogenic diet (2.5 to 4:1)

Modified Atkin's Diet

Outcomes

Primary Outcome Measures

Percentage of seizure reduction at 6 months ( sz frequency / wk average of 4 wks) from base line

To develop an optimal dietary therapy for management of refractory epilepsy in children and adolescents

Secondary Outcome Measures

Full Information

NCT ID

NCT01983163

First Posted

November 4, 2013

Last Updated

December 31, 2015

Sponsor

All India Institute of Medical Sciences, New Delhi

1. Study Identification

Unique Protocol Identification Number

NCT01983163

Brief Title

Dietary Therapy in Children With Refractory Epilepsy

Official Title

Efficacy of Modified Atkins Diet Versus Ketogenic Diet in Children With Refractory Epilepsy Aged 1 Year to 18 Years: a Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Completed

Study Start Date

April 2013 (undefined)

Primary Completion Date

June 2014 (Actual)

Study Completion Date

July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

All India Institute of Medical Sciences, New Delhi

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

In children aged 1yr -18 years with refractory epilepsy Modified Atkins diet as add on to ongoing AED therapy would not be inferior compared to ketogenic diet ** in terms of seizure reduction from baseline seizure frequency at 6 months

Detailed Description

Primary objective: To compare the efficacy of Modified Atkins diet compared to Ketogenic diet * in children aged 1 year to 18 years of age with refractory epilepsy on anti epileptic drugs at 6 months of diet intake in terms of percentage of seizure reduction from base line. Secondary objective: Proportion of patients who achieve > 50% seizure reduction from baseline after 6 months in both groups To evaluate the nature of adverse events in both the groups

6. Conditions and Keywords

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

Epilepsy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ketogenic diet

Arm Type

Active Comparator

Arm Description

ketogenic diet (2.5 to 4:1)

Arm Title

Modifid Atkin's diet

Arm Type

Active Comparator

Arm Description

Modified Atkin's Diet

Intervention Type

Other

Intervention Name(s)

Ketogenic diet (2.5 to 4:1)

Intervention Description

Minimum ratio (2.5 to4:1) ketogenic diet causing ketosis will be given

Intervention Type

Other

Intervention Name(s)

Modified Atkin's diet

Intervention Description

1:1 fixed ketogenic ratio Modified atkins diet will be given

Primary Outcome Measure Information:

Title

Percentage of seizure reduction at 6 months ( sz frequency / wk average of 4 wks) from base line

Description

To develop an optimal dietary therapy for management of refractory epilepsy in children and adolescents

Time Frame

Baseline and 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Year

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Children aged 1-18 years with refractory epilepsy* Willing to come for regular follow up No motivational or psychosocial issues in the family which would preclude compliance with the diet Exclusion Criteria Surgically remediable cause for refractory epilepsy Suspected mitochondrial disorder or diagnosed with a disorder in which high fat diet is contraindicated Previously received ketogenic diet or modified Atkins diet Chronic systemic disease like chronic kidney disease, chronic liver disease, heart disease (congenital and acquired) and chronic respiratory illness

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sheffali Gulati, MD

Organizational Affiliation

AIIMS, New Delhi

Official's Role

Principal Investigator

Facility Information:

Facility Name

All India Institute of Medical Sciences

City

New Delhi

State/Province

Delhi

ZIP/Postal Code

110029

Country

India

12. IPD Sharing Statement

Learn more about this trial

Dietary Therapy in Children With Refractory Epilepsy

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