A Phase 2 interventional study of ketogenic diet in Refractory Epilepsy, sponsored by Tehran University of Medical Sciences. Status unknown at 1 site in Iran, Islamic Republic of. Open to participants aged 1 Year to 18 Years. Per ClinicalTrials.gov, last updated 2017-01-25.
Sponsored by Tehran University of Medical Sciences · Phase 2, Interventional, and Treatment
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.
1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.
This study's planned enrollment of 30 is below the median of 50 across 1,206 interventional studies indexed under Epilepsy.
Browse Epilepsy studies →Tehran University of Medical Sciences is the lead sponsor of 227 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
Ketogenic diet
Other: ketogenic diet
Ketogenic Diet is a high fat, low carbohydrate diet.
seizure rate
The information will be obtained through seizure diary
Time frame: 3 months
Height
Height of the participants will be assessed by stadiometer and Unit for height is cm.
Time frame: Before and after 1 and 3 months on the classical KD.
Investigating side effects
Side effects will be obtained via parents' reports.
Time frame: After 3 months on the classical KD
serum Triglyceride
serum Triglyceride will be assessed. Units for serum TG, is mg/dl.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Before and after 3 months on the classical KD
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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Tehran University of Medical Sciences