- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03764956
Comparison of Efficacy of LGIT and MAD Among Children With Drug Resistant Epilepsy
September 9, 2019 updated by: Sheffali Gulati, All India Institute of Medical Sciences, New Delhi
Comparison of Efficacy of Low Glycemic Index Therapy and Modified Atkins Diet Among Children With Drug Resistant Epilepsy: A Randomized Non-inferiority Trial
To compare the efficacy of two less restrictive dietary therapies - LGIT and MAD, used for treatment of drug resistant epilepsy in children
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
110
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sheffali Gulati, MD
- Phone Number: 9810386847
- Email: sheffaligulati@gmail.com
Study Contact Backup
- Name: Vaishakh Anand, MD
- Phone Number: 7838528549
- Email: drvyshakhanandmp@gmail.com
Study Locations
-
-
Delhi
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New Delhi, Delhi, India, 110029
- Recruiting
- All India Institute of Medical Sciences
-
New Delhi, Delhi, India
- Recruiting
- AIIMS
-
Contact:
- Sheffali Gulati, M.D.
- Phone Number: 011 26594679
- Email: sheffaligulati@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 months to 13 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Low Glycemic Index therapy
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 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.
|
Active Comparator: Modified Atkins Diet
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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of seizure reduction from baseline at 24 weeks of therapy
Time Frame: At the end of 24 weeks of dietary therapy
|
Mean weekly seizure reduction at 24 weeks divided by Mean weekly seizure measured at baseline multiplied by 100
|
At the end of 24 weeks of dietary therapy
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of children who achieve >50% seizure reduction
Time Frame: At the end of 24 weeks of dietary therapy
|
Number of children with >50% reduction divided by number of children in each arm
|
At the end of 24 weeks of dietary therapy
|
Incidence of adverse events
Time Frame: At the end of 24 weeks of dietary therapy
|
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
|
At the end of 24 weeks of dietary therapy
|
Compliance of participants with dietary therapy in each arm will be determined each week, whether satisfactory or unsatisfactory
Time Frame: At the end of 24 weeks of dietary therapy
|
Weekly compliance assessment of each participant will be done
|
At the end of 24 weeks of dietary therapy
|
Change in Social quotient(SQ) with each dietary therapies
Time Frame: At the end of 24 weeks of dietary therapy
|
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.
|
At the end of 24 weeks of dietary therapy
|
Change in Quality of Life of participants who are less than 4 years of age at 24 weeks as compared to baseline
Time Frame: At the end of 24 weeks of dietary therapy
|
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.
|
At the end of 24 weeks of dietary therapy
|
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
Time Frame: At the end of 24 weeks of dietary therapy
|
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.
|
At the end of 24 weeks of dietary therapy
|
Change in Quality of Life of caregivers at 24 weeks as compared to baseline
Time Frame: At the end of 24 weeks of dietary therapy
|
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.
|
At the end of 24 weeks of dietary therapy
|
Gut microbiota (GM) analysis pre and post dietary therapy
Time Frame: At the end of 24 weeks of dietary therapy
|
Changes in percentage distribution of various micro organisms in gut microbiota after dietary therapy as compared to baseline GM
|
At the end of 24 weeks of dietary therapy
|
Change in behavioral abnormalities with each dietary therapy
Time Frame: At the end of 24 weeks of 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.
|
At the end of 24 weeks of dietary therapy
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Sheffali Gulati, MD, All India Institute of Medical Sciences, New Delhi
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 26, 2018
Primary Completion (Anticipated)
December 1, 2019
Study Completion (Anticipated)
December 1, 2019
Study Registration Dates
First Submitted
November 4, 2018
First Submitted That Met QC Criteria
December 4, 2018
First Posted (Actual)
December 5, 2018
Study Record Updates
Last Update Posted (Actual)
September 10, 2019
Last Update Submitted That Met QC Criteria
September 9, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IECPG/504/10/2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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