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In children aged 1yr -18 years with refractory epilepsy Modified Atkins diet as add on to ongoing AED therapy would not be inferior compared to ketogenic diet ** in terms of seizure reduction from baseline seizure frequency at 6 months
Primary objective:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ketogenic diet | Active Comparator | ketogenic diet (2.5 to 4:1) |
|
| Modifid Atkin's diet | Active Comparator | Modified Atkin's Diet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketogenic diet (2.5 to 4:1) | Other | Minimum ratio (2.5 to4:1) ketogenic diet causing ketosis will be given |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of seizure reduction at 6 months ( sz frequency / wk average of 4 wks) from base line | To develop an optimal dietary therapy for management of refractory epilepsy in children and adolescents | Baseline and 6 months |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Sheffali Gulati, MD | All India Institute of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| All India Institute of Medical Sciences | New Delhi | National Capital Territory of Delhi | 110029 | India |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D055423 | Diet, Ketogenic |
| ID | Term |
|---|---|
| D050528 | Diet, Carbohydrate-Restricted |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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| Modified Atkin's diet | Other | 1:1 fixed ketogenic ratio Modified atkins diet will be given |
|
| D004032 |
| Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |