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Comparison of Efficacy of LGIT and MAD Among Children With Drug Resistant Epilepsy

Primary Purpose

Drug Resistant Epilepsy, Ketogenic Dieting

Status
Unknown status
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Low glycemic Index Therapy (LGIT)
Modified Atkins Diet (MAD)
Sponsored by
All India Institute of Medical Sciences, New Delhi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Drug Resistant Epilepsy focused on measuring MAD, LGIT

Eligibility Criteria

1 Year - 15 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Children aged 1-15 years with drug resistant epilepsy
  • Willing to come for regular follow-up according to study protocol Drug resistant epilepsy defined as
  • Seizure frequency >4 seizures per month, while on optimal doses of at least 2 prescribed antiepileptic drugs
  • For West syndrome, drug resistant epilepsy will be defined as more than 4 clusters of spasms per month despite treatment with antiepileptic drugs and either ACTH(Adrenocorticotrophic hormone) or Vigabatrin

Exclusion Criteria:

  • Surgically remediable causes for DRE
  • Inborn errors of metabolism
  • Previously received KD, MAD or LGIT

  • Known case of

    1. Chronic kidney disease
    2. Chronic liver disease/GI illness
    3. Congenital/acquired heart disease
    4. Chronic respiratory illness

Sites / Locations

  • All India Institute of Medical SciencesRecruiting
  • AIIMSRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Low Glycemic Index therapy

Modified Atkins Diet

Arm Description

Specific dietary therapy called Low glycemic Index Therapy (LGIT) which provides diet including food items with glycemic index less than 50 only

Specific dietary therapy called Modified Atkins Diet (MAD) which provides diet with restricted carbohydrates upto 20 grams per day and increased fat and protein ratio

Outcomes

Primary Outcome Measures

Percentage of seizure reduction from baseline at 24 weeks of therapy
Mean weekly seizure reduction at 24 weeks divided by Mean weekly seizure measured at baseline multiplied by 100

Secondary Outcome Measures

Proportion of children who achieve >50% seizure reduction
Number of children with >50% reduction divided by number of children in each arm
Incidence of adverse events
Routine hemogram, Renal function test (RFT), Liver function test (LFT) and lipid profile will be assessed for any alterations. Adverse events, vomiting, constipation and diarrhea will be checked by parents record
Compliance of participants with dietary therapy in each arm will be determined each week, whether satisfactory or unsatisfactory
Weekly compliance assessment of each participant will be done
Change in Social quotient(SQ) with each dietary therapies
Proportion of children with improvement in Social quotient (SQ) assessed by Vineland Social Maturity Scale (VSMS) at 24 weeks. VSMS consists of 8 subsets - Communication skills, General self-help ability, Locomotion skills, Occupation skills, Self-direction, Self-help eating, Self-help dressing, Socialization skills. Social age is calculated by adding the scores of all subsets. Social quotient (SQ) is calculated by social age divided by chronological age multiplied by 100.
Change in Quality of Life of participants who are less than 4 years of age at 24 weeks as compared to baseline
In children less than 4 years quality of life is assessed by PedsQL (Pediatric Quality of life inventory). PedsQL consists of 21 questions each having 5 responses with scores 0,1,2,3 and 4. Minimum score is 0 and maximum is 84. Quality of life is poor with larger score.
Change in Quality of Life of participants who are more than or equal to 4 years of age at 24 weeks as compared to baseline
In children with age 4 years or more, QOLCE 55 (Quality of life in childhood epilepsy questionnaire) is used to assess quality of life. QOLCE 55 consists of 55 questions which are classified into 4 categories. Each question have 5 responses with scores as 0,25,50,75 and 100. Mean score of each category is calculated and final score calculated by mean of the scores of 4 categories. Minimum score is 0 and maximum is 100. Quality of life is better with larger score.
Change in Quality of Life of caregivers at 24 weeks as compared to baseline
Quality of life of caregivers is assessed by WHOQOL-BREF. WHOQOL BREF contains 26 items categorized into 4 domains. For each question response is scored 1,2,3,4 or 5. Total raw score is then calculated and is converted to transformed score. Minimum score is 0 and maximum is 100. Quality of life is poor with smaller score.
Gut microbiota (GM) analysis pre and post dietary therapy
Changes in percentage distribution of various micro organisms in gut microbiota after dietary therapy as compared to baseline GM
Change in behavioral abnormalities with each dietary therapy
Behavior assessment is done using Child behavior check list (CBCL).This questionnaire contains 100 and 113 questions for age groups of 1 ½ - 5 years and 6-18 years respectively. Score of 2 will be given for a response of 'very true', 1 for a response of 'somewhat true' and 0 for 'not true'. Total score is obtained by adding all the subsets. Subsets for age 1.5 years to 5 years include - Emotionally reactive, anxious/depressed, somatic complaints, withdrawn, sleep problems, attention problems, aggressive behavior and other problems. Subsets for age 6 years to 12 years include - Anxious/Depressed, withdrawn, somatic complaints, social problems, thought problems, attention problems, rule breaking behavior, aggressive behavior, other problems. Raw score is then converted to T score according to the published charts. Minimum T score is 28 and maximum is 100. Larger score indicates more behavioral problems.

Full Information

First Posted
November 4, 2018
Last Updated
September 9, 2019
Sponsor
All India Institute of Medical Sciences, New Delhi
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1. Study Identification

Unique Protocol Identification Number
NCT03764956
Brief Title
Comparison of Efficacy of LGIT and MAD Among Children With Drug Resistant Epilepsy
Official Title
Comparison of Efficacy of Low Glycemic Index Therapy and Modified Atkins Diet Among Children With Drug Resistant Epilepsy: A Randomized Non-inferiority Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 26, 2018 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
All India Institute of Medical Sciences, New Delhi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To compare the efficacy of two less restrictive dietary therapies - LGIT and MAD, used for treatment of drug resistant epilepsy in children
Detailed Description
Up to one third of patients with epilepsy progress to drug resistant epilepsy (DRE). Current treatment options for DRE include epileptic surgery and dietary therapy. Classic KD (Ketogenic diet) is the most studied dietary therapy but the stringent restrictions and practical difficulty makes it difficult to follow. So less restrictive diets like MAD and LGIT were introduced. These are reported to have less adverse effects also. But no published study has ever been conducted comparing these two diets head to head.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Resistant Epilepsy, Ketogenic Dieting
Keywords
MAD, LGIT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Open label randomized non inferiority trial with two parallel arms
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low Glycemic Index therapy
Arm Type
Experimental
Arm Description
Specific dietary therapy called Low glycemic Index Therapy (LGIT) which provides diet including food items with glycemic index less than 50 only
Arm Title
Modified Atkins Diet
Arm Type
Active Comparator
Arm Description
Specific dietary therapy called Modified Atkins Diet (MAD) which provides diet with restricted carbohydrates upto 20 grams per day and increased fat and protein ratio
Intervention Type
Other
Intervention Name(s)
Low glycemic Index Therapy (LGIT)
Intervention Description
Specific dietary therapy called Low glycemic Index Therapy (LGIT) which provides diet including food items with glycemic index less than 50 only. For this purpose, various dietary menus will be provided to the parents.
Intervention Type
Other
Intervention Name(s)
Modified Atkins Diet (MAD)
Intervention Description
Specific dietary therapy called Modified Atkins Diet (MAD) which provides diet with restricted carbohydrates upto 20 grams per day and increased fat and protein ratio. For this purpose, various dietary menus will be provided to the parents.
Primary Outcome Measure Information:
Title
Percentage of seizure reduction from baseline at 24 weeks of therapy
Description
Mean weekly seizure reduction at 24 weeks divided by Mean weekly seizure measured at baseline multiplied by 100
Time Frame
At the end of 24 weeks of dietary therapy
Secondary Outcome Measure Information:
Title
Proportion of children who achieve >50% seizure reduction
Description
Number of children with >50% reduction divided by number of children in each arm
Time Frame
At the end of 24 weeks of dietary therapy
Title
Incidence of adverse events
Description
Routine hemogram, Renal function test (RFT), Liver function test (LFT) and lipid profile will be assessed for any alterations. Adverse events, vomiting, constipation and diarrhea will be checked by parents record
Time Frame
At the end of 24 weeks of dietary therapy
Title
Compliance of participants with dietary therapy in each arm will be determined each week, whether satisfactory or unsatisfactory
Description
Weekly compliance assessment of each participant will be done
Time Frame
At the end of 24 weeks of dietary therapy
Title
Change in Social quotient(SQ) with each dietary therapies
Description
Proportion of children with improvement in Social quotient (SQ) assessed by Vineland Social Maturity Scale (VSMS) at 24 weeks. VSMS consists of 8 subsets - Communication skills, General self-help ability, Locomotion skills, Occupation skills, Self-direction, Self-help eating, Self-help dressing, Socialization skills. Social age is calculated by adding the scores of all subsets. Social quotient (SQ) is calculated by social age divided by chronological age multiplied by 100.
Time Frame
At the end of 24 weeks of dietary therapy
Title
Change in Quality of Life of participants who are less than 4 years of age at 24 weeks as compared to baseline
Description
In children less than 4 years quality of life is assessed by PedsQL (Pediatric Quality of life inventory). PedsQL consists of 21 questions each having 5 responses with scores 0,1,2,3 and 4. Minimum score is 0 and maximum is 84. Quality of life is poor with larger score.
Time Frame
At the end of 24 weeks of dietary therapy
Title
Change in Quality of Life of participants who are more than or equal to 4 years of age at 24 weeks as compared to baseline
Description
In children with age 4 years or more, QOLCE 55 (Quality of life in childhood epilepsy questionnaire) is used to assess quality of life. QOLCE 55 consists of 55 questions which are classified into 4 categories. Each question have 5 responses with scores as 0,25,50,75 and 100. Mean score of each category is calculated and final score calculated by mean of the scores of 4 categories. Minimum score is 0 and maximum is 100. Quality of life is better with larger score.
Time Frame
At the end of 24 weeks of dietary therapy
Title
Change in Quality of Life of caregivers at 24 weeks as compared to baseline
Description
Quality of life of caregivers is assessed by WHOQOL-BREF. WHOQOL BREF contains 26 items categorized into 4 domains. For each question response is scored 1,2,3,4 or 5. Total raw score is then calculated and is converted to transformed score. Minimum score is 0 and maximum is 100. Quality of life is poor with smaller score.
Time Frame
At the end of 24 weeks of dietary therapy
Title
Gut microbiota (GM) analysis pre and post dietary therapy
Description
Changes in percentage distribution of various micro organisms in gut microbiota after dietary therapy as compared to baseline GM
Time Frame
At the end of 24 weeks of dietary therapy
Title
Change in behavioral abnormalities with each dietary therapy
Description
Behavior assessment is done using Child behavior check list (CBCL).This questionnaire contains 100 and 113 questions for age groups of 1 ½ - 5 years and 6-18 years respectively. Score of 2 will be given for a response of 'very true', 1 for a response of 'somewhat true' and 0 for 'not true'. Total score is obtained by adding all the subsets. Subsets for age 1.5 years to 5 years include - Emotionally reactive, anxious/depressed, somatic complaints, withdrawn, sleep problems, attention problems, aggressive behavior and other problems. Subsets for age 6 years to 12 years include - Anxious/Depressed, withdrawn, somatic complaints, social problems, thought problems, attention problems, rule breaking behavior, aggressive behavior, other problems. Raw score is then converted to T score according to the published charts. Minimum T score is 28 and maximum is 100. Larger score indicates more behavioral problems.
Time Frame
At the end of 24 weeks of dietary therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children aged 1-15 years with drug resistant epilepsy Willing to come for regular follow-up according to study protocol Drug resistant epilepsy defined as Seizure frequency >4 seizures per month, while on optimal doses of at least 2 prescribed antiepileptic drugs For West syndrome, drug resistant epilepsy will be defined as more than 4 clusters of spasms per month despite treatment with antiepileptic drugs and either ACTH(Adrenocorticotrophic hormone) or Vigabatrin Exclusion Criteria: Surgically remediable causes for DRE Inborn errors of metabolism Previously received KD, MAD or LGIT Known case of Chronic kidney disease Chronic liver disease/GI illness Congenital/acquired heart disease Chronic respiratory illness
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sheffali Gulati, MD
Phone
9810386847
Email
sheffaligulati@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Vaishakh Anand, MD
Phone
7838528549
Email
drvyshakhanandmp@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sheffali Gulati, MD
Organizational Affiliation
All India Institute of Medical Sciences, 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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gulati Sheffali, MD
Phone
9868397532
Email
sheffaligulati@gmail.com
First Name & Middle Initial & Last Name & Degree
Gulati Sheffali, MD
Facility Name
AIIMS
City
New Delhi
State/Province
Delhi
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sheffali Gulati, M.D.
Phone
26594679
Ext
011
Email
sheffaligulati@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Comparison of Efficacy of LGIT and MAD Among Children With Drug Resistant Epilepsy

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