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This study will consider the effectiveness of the ketogenic diet (high-fat, low-carbohydrate, and moderate protein) in treating epilepsy. Investigators enroll a group of eligible epileptic children and adolescent who have been referred from epilepsy center to our clinic and prescribe them ketogenic diet.
This research will be done to observe efficacy, safety, and tolerability of the classic ketogenic diet (CKD) on an outpatient basis without fasting, caloric and fluid restriction in children with and adolescents with intractable epilepsy.
30 children and adolescents with intractable epilepsy based on inclusion and exclusion criteria have been enrolled in the study, Investigators prescribe them classic ketogenic diet. Efficacy of the diet will be assessed through seizure rates, number of anti-epileptic drug used by the patients, and EEG changes. Seizure frequency will be assessed by seizure record diary that is filled out by family of the patients and will be compared with data that will be taken at 1, 3 months after start of the diet. EEG will be taken at baseline and 3 months after start of the diet. Patients will be reviewed at 1, 3 months after start of the diet at outpatient clinic. Intolerances and Complications will be documented at each clinic visits and via telephone calling during clinic visits intervals to evaluate tolerability and safety of the KD. For close monitoring of the complications along with blood tests and urinalysis Investigators will do echocardiography and renal ultrasound at baseline and 3 months after start of the diet. Laboratory values will be assessed at baseline and 3 months after start of the diet. Also, nutritional status and growth of children will be assessed at baseline and 1, 3 months after start of diet.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ketogenic diet | Other | Ketogenic diet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ketogenic diet | Other | Ketogenic Diet is a high fat, low carbohydrate diet. |
|
| Measure | Description | Time Frame |
|---|---|---|
| seizure rate | The information will be obtained through seizure diary | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Height | Height of the participants will be assessed by stadiometer and Unit for height is cm. | Before and after 1 and 3 months on the classical KD. |
| Investigating side effects | Side effects will be obtained via parents' reports. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maryam Mahmoudi, MD, PHD | Contact | 00989126182883 | m-mahmoudi@sina.tums.ac.ir | |
| Mona Kavoosi, MSc student | Contact | 00989123759711 | m_kavoosi@razi.tums.ac.ir |
| Name | Affiliation | Role |
|---|---|---|
| Maryam Mahmoudi, MD, PHD | Tehran university of medical science, school of Nutritional science and Dietetics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tehran university of medical science, school of nutritional science and dietetics | Recruiting | Tehran | Tehran Province | Iran |
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| ID | Term |
|---|---|
| D000069279 | Drug Resistant Epilepsy |
| 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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| After 3 months on the classical KD |
| serum Triglyceride | serum Triglyceride will be assessed. Units for serum TG, is mg/dl. | Before and after 3 months on the classical KD |
| Weight | Weight of the participants will be assessed by seca scale and Unit for weight is kilogram. | Before and after 1 and 3 months on the classical KD. |
| serum Cholesterol, | serum Cholesterol will be assessed. Units for serum Cholesterol is mg/dL. | Before and after 3 months on the classical KD |
| serum LDL-Cholesterol | serum LDL-Cholesterol will be assessed. Units for serum LDL-C is mg/dL. | Before and after 3 months on the classical KD. |
| serum HDL-Cholesterol | serum HDL-Cholesterol will be assessed. Units for serum HDL-C is mg/dL | Before and after 3 months on the classical KD |
| D004032 |
| Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |