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Epilepsy is one of a common neurological disorder. Antiepileptic drugs (AEDs) are usually the primary treatment of epilepsy. However, almost 30% of patients do not respond to AEDs and other treatments including ketogenic diet (KD) are used. The Ketogenic Diet (KD) is a low-carbohydrate, high fat, adequate-protein diet. In this study, investigators are going to compare two kinds of the ketogenic diet namely classical ketogenic diet and modified Atkins diet. Fifty children and adolescents with intractable epilepsy will be included, 25 patients in each group, and will receive the diet for three months on non-randomised basis. In the classical ketogenic diet, the diet with a ratio of 4 to 1 (4:1), each 4 grams of fat to each gram of carbohydrate plus protein, will be introduced. Classical ketogenic diet will be established on outpatient setting, without fasting and gradually. The modified Atkins diet will be applied by the ratio of 1:1 or 2:1, each 1 or 2 grams of fat to each gram of carbohydrate plus protein.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Classical ketogenic diet | Active Comparator | The classical ketogenic diet with 4:1 ketogenic ratio, each 4 grams of fat to each gram of carbohydrate plus protein, will be introduced. |
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| Modified Atkins diet | Active Comparator | The modified Atkins diet with a ratio of 1 or 2 to 1 (1:1, 2:1), each 1 or 2 grams of fat to each gram of carbohydrate plus protein, will be introduced gradually. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Classical ketogenic diet | Other | The classical ketogenic diet with a ratio of 4 to 1 (4:1), each 4 grams of fat to each gram of carbohydrate plus protein, will be introduced gradually. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the efficacy of the outpatient classical ketogenic diet and modified atkins diet | Prior to and three months after initiation of the classical ketogenic diet and modified Atkins diet |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the nutritional status of children and adolescents on the classical KD and MAD | Baseline and three months after initiation of the classical ketogenic diet and modified Atkins diet | |
| Comparison of the lipid profiles of children and adolescents on the classical KD and MAD |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Childrens' Medical Center, Tehran University of Medical Sciences | Tehran | 1419733151 | Iran |
The IPD would not share with other researchers.
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| Modified Atkins diet | Other | The modified Atkins diet with a ratio of 1 or 2 to 1 (1:1, 2:1), each 1 or 2 grams of fat to each gram of carbohydrate plus protein, will be introduced gradually. |
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| Baseline and three months after initiation of the classical ketogenic diet and modified Atkins diet |
| Comparison of the serum electrolytes levels of children and adolescents on the classical KD and MAD | Baseline and three months after initiation of the classical ketogenic diet and modified Atkins diet |
| ID | Term |
|---|---|
| D000069279 | Drug Resistant Epilepsy |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C110804 | mycophenolic adenine dinucleotide |
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