Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
30 participants
INTERVENTIONAL
2013-04-30
2014-07-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ketogenic diet
ketogenic diet (2.5 to 4:1)
Ketogenic diet (2.5 to 4:1)
Minimum ratio (2.5 to4:1) ketogenic diet causing ketosis will be given
Modifid Atkin's diet
Modified Atkin's Diet
Modified Atkin's diet
1:1 fixed ketogenic ratio Modified atkins diet will be given
Interventions
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Ketogenic diet (2.5 to 4:1)
Minimum ratio (2.5 to4:1) ketogenic diet causing ketosis will be given
Modified Atkin's diet
1:1 fixed ketogenic ratio Modified atkins diet will be given
Eligibility Criteria
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Inclusion Criteria
* Willing to come for regular follow up
* No motivational or psychosocial issues in the family which would preclude compliance with the diet
Exclusion Criteria
* 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
1 Year
18 Years
ALL
No
Sponsors
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All India Institute of Medical Sciences
OTHER
Responsible Party
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Sheffali Gulati
Addl. Professor
Principal Investigators
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Sheffali Gulati, MD
Role: PRINCIPAL_INVESTIGATOR
AIIMS, New Delhi
Locations
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All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, India
Countries
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Other Identifiers
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9968480606
Identifier Type: -
Identifier Source: org_study_id
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