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IRCT201210016907N5 IRCT 2014-06-28 NUTRICIA Effect of ketocal formula on the seizure Clinical trial of the effect of Ketocal formula on the frequency of seizure in 1-5-Year-Old children suffering from Intractable epilepsy to antiepileptic drugs. 2014-05-27 anticipated 30 Complete https://irct.ir/trial/7341 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. N/A Epilepsy. This intervention is conducted, without control group, and the same patients suffering from intractable epilepsy are studied prior to and after being fed with the Ketocal formula. The volume of the formula will gradually increase until Ketone appears in the urine. Then, the frequency of seizures per week, side effects and tolerability in the four months of prescription of the formula will be assessed. The frequency of seizures are compared with those occurred prior to the commencement of the treatment..
public Seyed Ahmad Hosseini
Children's Medical Center, Qarib Street, Tehran
Tehran Iran (Islamic Republic of) +98 21 6693 5848 parnianah@yahoo.com Tehran University of Medical Sciences scientific Mahmmoud Reza Ashrafi
Children's Medical Center, Qarib street, Tehran
Tehran Iran (Islamic Republic of) +98 21 6693 5848 mr_ashrafi@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: Having seizures which are intractable with at least two anti-epileptic medications, and having seizures once in every month, on average, in the last year; having no contraindication in respect of Ketogenic diet based on the reviewed sources. Exclusion criteria: Acute complications due to the treatment, leading to withholding the treatment. 12 months 5 years Both G40 Epilep Episodic and paroxysmal disorders Treatment - Other This intervention is conducted, without control group, and the same patients suffering from intractable epilepsy are studied prior to and after being fed with the Ketocal formula. The volume of the formula will gradually increase until Ketone appears in the urine. Then, the frequency of seizures per week, side effects and tolerability in the four months of prescription of the formula will be assessed. The frequency of seizures are compared with those occurred prior to the commencement of the treatment. Seizure frequency. Timepoint: Before intervention and during intervention. Method of measurement: Average of sezure frequency per week. Toerability to ketocal diet. Timepoint: During intervention. Method of measurement: Descriptional. Blood lipid profile(cholestrol, teriglyceride, LDL, HDL). Timepoint: At biginning and end of intervention. Method of measurement: Blood sampling and laboratory measurement. Blood calcium. Timepoint: At biginning and end of intervention. Method of measurement: Blood sampling and laboratory measurement. Serum vitamine 25 hydroxy vitamine D. Timepoint: At biginning and end of intrvention. Method of measurement: Blood sampling and laboratory measurement. Side effects. Timepoint: Durin intervention. Method of measurement: Parents report. Serum zinc. Timepoint: At biginning and end of interventon. Method of measurement: Blood sampling and laboratory measurement. Blood glucose. Timepoint: At biginning and end of intervention and when the patient feels weakness. Method of measurement: Blood sampling and laboratory measurement and glucometery. Blood alkalyn phosphatase. Timepoint: At biginning and end of intervention. Method of measurement: Blood sampling and laboratory measurement. Blood urea. Timepoint: At biginning and end of intervention. Method of measurement: Blood sampling and laboratory measurement. Plasma creatinine. Timepoint: At biginning and end of intervention. Method of measurement: Blood sampling and laboratory measurement. NUTRICIA Approved 2014-05-25 Tehran University of Medical Siences Sixth floor, Headquarter for Tehran University of Medical Sciences, On the Corner of Keshavarz Blvd. and Qods Street, Keshavarz Blvd., Tehran, Iran Tehran Iran (Islamic Republic of)