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IRCT20170420033551N5 IRCT 2019-07-02 National Institute for Medical Research Development of Iran (NIMAD) The effect of vitamin D supplementation in treatment of patients with epilepsy The effect of vitamin D supplementation on seizure frequency, mental health parameters, metabolic and genetic profiles in patients with epilepsy 2019-02-03 anticipated 90 Complete https://irct.ir/trial/40116 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: To decrease potential confounding effects, all participants will have stratified randomization according to gender (male vs. female), type of seizures (tonic-clonic vs. partial) and circulating levels of vitamin D at baseline (<15 vs. 15-29.9 ng/mL). Then, participants in each block will be randomly allocated into two treatment groups to take either supplements or placebo. Randomization will be done by the use of computer software, Blinding description: Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the neurology clinic, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of supplements. 3 Epilepsy and recurrent seizures. Intervention 1: Intervention group: 50000 IU vitamin D (Zahravi, Tabriz, Iran), every 2 weeks, for 12 weeks orally. Intervention 2: Control group: Placebo (Barij Essence, Kashan, Iran), every 2 weeks, for 12 weeks orally. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Undecided - It is not yet known if there will be a plan to make this available
public Amir Ghaderi
Ghotbe Ravandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 8115187159 +98 31 5546 3378 ghaderi-am@kaums.ac.ir Kashan University of Medical Sciences scientific Dr. Hamidreza Banafsheh
Ghotbe Ravandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 8115187159 +98 31 5546 3378 banafsheh.hr@gmail.com Kashan University of Medical Sciences Iran (Islamic Republic of) Patients diagnosed with epilepsy Individuals aged 9 to 18 years vitamin D insufficiency or deficiency (serum 25- hydroxyvitamin D <30 ng/mL) 9 years 18 years Both History of acute or chronic liver diseases History of renal insufficiency metabolic disorders infectious diseases autoimmune diseases hematologic disorders Taking vitamin D, calcium, and other antioxidant supplements in the last 3 months and during the study G40 Epilepsy and recurrent seizures Treatment - Drugs Placebo Intervention group: 50000 IU vitamin D (Zahravi, Tabriz, Iran), every 2 weeks, for 12 weeks orally. Control group: Placebo (Barij Essence, Kashan, Iran), every 2 weeks, for 12 weeks orally. Beck depression inventory. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Questionnaire. The frequency of seizures. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: checklist. Beck anxiety inventory. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Questionnaire. Hs-CRP. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit. Nitric oxide. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry. Total antioxidant capacity. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry. Total glutathione. Timepoint: At the beginning of the study and 12 weeks after intervention. Method of measurement: Spectrophotometry. Malondialdehyde. Timepoint: At the beginning of the study and 12 weeks after intervention. Method of measurement: Spectrophotometry. Fasting plasma glucose. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. Insulin. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit. HDL. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. Total cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. Triglycerides. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. Expressed levels of IL-1 gene. Timepoint: At the beginning of the study and 12 weeks after intervention. Method of measurement: RT-PCR. Expressed levels of IL-6 gene. Timepoint: At the beginning of the study and 12 weeks after intervention. Method of measurement: RT-PCR. Expressed levels of TNF-a gene. Timepoint: At the beginning of the study and 12 weeks after intervention. Method of measurement: RT-PCR. Expressed levels of PPAR-γ. Timepoint: At the beginning of the study and 12 weeks after intervention. Method of measurement: RT-PCR. National Institute for Medical Research Development of Iran (NIMAD) Approved 2019-02-02 Ethics committee of National Institute for Medical Research Development of Iran (NIMAD) National Institute for Medical Research Development of Iran, Fatemi Avenue, Tehran Tehran Tehran Iran (Islamic Republic of)