Comparison of Efficacy of Low Glycemic Index Therapy and Modified Atkins Diet Among Children With Drug Resistant Epilepsy: A Randomized Non-inferiority Trial
Sponsor study identifier
interventional
110
1 country
2
Study Start
December 26, 2018
Actual (reported)Primary Completion
December 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
To compare the efficacy of two less restrictive dietary therapies - LGIT and MAD, used for treatment of drug resistant epilepsy in children
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 4, 2018
Actual (reported)December 5, 2018
Actual (reported)December 26, 2018
Actual (reported)December 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
At the end of 24 weeks of dietary therapy
Proportion of children who achieve >50% seizure reduction
At the end of 24 weeks of dietary therapy
Incidence of adverse events
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
At the end of 24 weeks of dietary therapy
Change in Social quotient(SQ) with each dietary therapies
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
At the end of 24 weeks of dietary 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 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 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.
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.
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, 110029, India
AIIMS
New Delhi, National Capital Territory of Delhi, India
Sheffali Gulati, MD
All India Institute of Medical Sciences
First Submitted
November 4, 2018
First Posted
December 5, 2018
Study Start
December 26, 2018
Actual (reported)Primary Completion
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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December 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
September 10, 2019
Record last verified: 2019-09
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