- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03464487
Comparison Between Efficacy of Daily and Intermittent Low Glycemic Index Therapy Diet
March 7, 2018 updated by: Sheffali Gulati, All India Institute of Medical Sciences, New Delhi
Comparison Between Efficacy of Daily and Intermittent Low Glycemic Index Therapy Diet Among Children With Drug Resistant Epilepsy Aged 1-15 Years: an Open Labeled Randomized Controlled Parallel Design Non-inferiority Trial
Drug resistant epilepsy constitutes about one third of all children diagnosed with epilepsy.
Although ketogenic diet is being used for drug resistant epilepsy for almost hundred years, its restrictiveness and adverse effects interferes with its compliance.
So less restrictive alternatives like Low Glycemic Index Therapy diet is gradually becoming more popular and its effectiveness is well established.
Still the restrictiveness of such monotonous diets is one of the most significant issues for long term maintenance of children on dietary therapy.
In this study, we are planning to compare the efficacy of daily and intermittent Low Glycemic Index therapy Diet in children aged 1-15 years with drug resistant epilepsy in a open labelled randomized controlled non-inferiority trial.
The children in intermittent LGIT arm will receive the dietary therapy for five days of each week, alternating with a liberal diet on the rest of the two days of the week.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Drug resistant epilepsy constitutes about one third of all children diagnosed with epilepsy.
Although ketogenic diet is being used for drug resistant epilepsy for almost hundred years, its restrictiveness and adverse effects interferes with its compliance.
So less restrictive alternatives like Low Glycemic Index Therapy diet is gradually becoming more popular and its effectiveness is well established.
Still the restrictiveness of such monotonous diets is one of the most significant issues for long term maintenance of children on dietary therapy.
In this study, we are planning to compare the efficacy of daily and intermittent Low Glycemic Index therapy Diet in children aged 1-15 years with drug resistant epilepsy in a open labelled randomized controlled non-inferiority trial.
The children in intermittent LGIT arm will receive the dietary therapy for five days of each week, alternating with a liberal diet on the rest of the two days of the week.
With a follow up period of 6 months, we are planning to enroll 55 children in each arm.
Adverse effect profile in each arm will also be monitored during the study.
Also the effect of the dietary therapy on behavior and cognition in each arm will be assessed.
Study Type
Interventional
Enrollment (Anticipated)
110
Phase
- Not Applicable
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, M.D.
- Phone Number: 011 26594679
- Email: sheffaligulati@gmail.com
Study Locations
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Delhi
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New Delhi, Delhi, India
- Recruiting
- AIIMS
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Contact:
- Sheffali Gulati, M.D.
- Phone Number: 011 26594679
- Email: sheffaligulati@gmail.com
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-
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
1 year to 15 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
Exclusion Criteria:
- Surgically remediable cause for drug resistant epilepsy
- Proven in born error of metabolism except in which dietary therapy for epilepsy is indicated(i.e. pyruvate carboxylase deficiency and GLUT 1 deficiency)
- Previously received KD, MAD or LGIT
Known case of
- Chronic kidney disease
- Chronic liver disease/GI illness
- Chronic heart disease(congenital and acquired)
- 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 |
---|---|
Active Comparator: Daily LGIT
The children with drug resistant epilepsy in this arm will receive Low Glycemic Index Therapy diet everyday along with the antiepileptic drugs.
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Low Glycemic Index Therapy Diet allows only carbohydrates with Glycemic Index less than 50 and also restricts daily carbohydrate intake to less than 40-60 gram per day.
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Active Comparator: Intermittent LGIT
The children with drug resistant epilepsy in this arm will receive Low Glycemic Index Therapy Diet on five days of each week along with antiepileptic drugs.
Rest of the two days, they will receive a liberal diet.
|
Low Glycemic Index Therapy Diet allows only carbohydrates with Glycemic Index less than 50 and also restricts daily carbohydrate intake to less than 40-60 gram per day.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of seizure reduction from baseline at 24 weeks in each arm
Time Frame: Percentage seizure reduction will be calculated for each child in each arm after 24 weeks follow up period is completed and finally mean seizure reduction in each arm will be computed at the end of 24 weeks
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Percentage of seizure reduction from baseline at 24 weeks in each arm will be calculated from Daily Seizure Log maintained by parents Percentage of seizure reduction at 24 weeks=x-y/x X 100 Y=Mean daily seizures at 24 weeks as measured over past 4 weeks X=Mean daily seizures at baseline as measured over 4 weeks Seizure log will contain details of number, duration and type of seizures as recorded by parents
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Percentage seizure reduction will be calculated for each child in each arm after 24 weeks follow up period is completed and finally mean seizure reduction in each arm will be computed at the end of 24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of patients with >50% seizure reduction in each dietary arm
Time Frame: At the end of 24 weeks, it will be determined the proportion of children in each arm with >50% reduction in seizure frequency.
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Proportion of patients with >50% seizure reduction in each dietary arm will be computed from daily seizure log maintained by parents
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At the end of 24 weeks, it will be determined the proportion of children in each arm with >50% reduction in seizure frequency.
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Change in social quotient with each dietary therapy
Time Frame: Vineland Social Maturity Scale will be done for each child at baseline and at 24 weeks to calculate social quotient at baseline and 24 weeks
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Proportion of children with improvement in social quotient at 24 weeks as compared to baseline measured by Vineland Social Maturity scale
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Vineland Social Maturity Scale will be done for each child at baseline and at 24 weeks to calculate social quotient at baseline and 24 weeks
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Proportion of patients with different clinical adverse events in each group
Time Frame: Each child will be monitored for adverse effects clinically at 12 weeks and 24 weeks
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Each participant will be monitored clinically for adverse effects like nausea, vomiting, constipation
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Each child will be monitored for adverse effects clinically at 12 weeks and 24 weeks
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Correlate seizure frequency change at 24 weeks with blood HbA1c levels
Time Frame: Absolute level of HbA1c levels (in percentage) as compared to percentage change in seizure frequency at 3 and 6 months will be computed
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Absolute level of blood HbA1c(in percentage) as compared to percentage change in seizure frequency at 3 and 6 months will be computed
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Absolute level of HbA1c levels (in percentage) as compared to percentage change in seizure frequency at 3 and 6 months will be computed
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Correlate seizure frequency change at 24 weeks with blood betahydroxy butyrate levels levels
Time Frame: Blood beta hydroxyl butyrate levels(milimoles/liter) at 12 and 24 weeks as compared to percentage change in seizure frequency will be computed
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Blood beta hydroxyl butyrate levels(milimoles/liter) at 12 and 24 weeks as compared to percentage change in seizure frequency will be computed
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Blood beta hydroxyl butyrate levels(milimoles/liter) at 12 and 24 weeks as compared to percentage change in seizure frequency will be computed
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Proportion of patients with different biochemical adverse events in each group
Time Frame: Each child will be monitored by certain biochemical investigations like hemoglobin, liver and renal function tests and lipid profile at baseline, at 24 weeks and also in between if clinically indicated
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Each participant will be monitored for side effects like anemia, dyslipidemia, deranged liver and renal function tests
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Each child will be monitored by certain biochemical investigations like hemoglobin, liver and renal function tests and lipid profile at baseline, at 24 weeks and also in between if clinically indicated
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Sheffali Gulati, M.D., AIIMS, 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)
February 15, 2018
Primary Completion (Anticipated)
January 1, 2019
Study Completion (Anticipated)
January 1, 2019
Study Registration Dates
First Submitted
January 1, 2018
First Submitted That Met QC Criteria
March 7, 2018
First Posted (Actual)
March 14, 2018
Study Record Updates
Last Update Posted (Actual)
March 14, 2018
Last Update Submitted That Met QC Criteria
March 7, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Daily vs Intermittent LGIT
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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