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IRCT20101209005352N3 IRCT 2018-10-29 Zanjan University of Medical Sciences Selenium in epilepsy. Effectiveness of selenium in epileptic patient’s cognitive function compared with control group 2018-08-06 anticipated 70 Complete https://irct.ir/trial/30225 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Simple randomization is based on random allocation rule which has different way to do .in this study 35 is used for first group & the same number is used for rhe second group. after mixing rhe cards one card is extracted & allocation is recorded then backed to the others. this process continue until reaching to the randomized succession according to the sample size. non transparent cards is used for allocation concealment, Blinding description: For All patients who participate in the study are explained that they will be divide into two groups. one group will receive drug and the other wil‌ receive placebo but any patient know about which group she/he is placed. 3 Epilepsy. Intervention 1: Intervention group: epileptic patients,tab selenium 200mcg ,one tabletin at breakfast for 4months ,21centry(purapakhsh)company included purified selenium; as an antioxidant. Intervention 2: Control group: epileptic patients,tab selenium placebo 200mcg,one tab at breakfast ,for 4months,purapakhsh company. Title: Comparative Study of Selenium and Placebo on Cognitive Function in Epileptic Patients Background: Epilepsy is an important health problem and the second most common neurologic dilemma following stroke . Cognitive problems are common within epileptic patients, resulting from many causes such as brain lesions, frequency of seizures, type of treatment, chronic and severe epilepsy and polytherapy. There is a strong evidence about the evolution of cognitive problems from early stages of the disease. Selenium can be benefical for cognitive function due to its lowering effect on oxidative stress. This study was aimed to evaluate selenium effect on epileptic patients cognitive function. Methods: In this clinical trial ,70 patients with idiopathic generalized tonic_ clonic epilepsy were enrolled through simple randomized single blind method and divided into the case and control groups. Before they receive the treatment ,cognitive evaluation was made by MOCA test; then the case group and control groups received selenium (200 mcg)and placebo respectively. Evaluation via MOCA test was repeated two & four months following the treatment initiation. we compared the effectiveness of selenium and placebo on cognitive function. Data analysis was performed through SPSS 24 ; independent t-test and Chi square test were used for comparing the groups. Results: 70 patients with idiopathic generalized Tonic- clonic epilepsy between 20-65 years of age were evaluated in the two groups; the control group (35 patients)and the case group(35 patients).MOCA test average score was 24.49 in the placebo group(maximum 30 and minimum 19) and 24.91 in the case group(maximum 30 and minimum 16) after 2 month of study. At the end of the 4th month , the MOCA test average score was 24.54 in the placebo group (maximum 30, minimum 19) and 26.31 in the case group(maximum 30,minimum 16). The study findings did not demonstrate any significant difference between selenium and placebo. Conclusion: The results of this study showed that selenium supplement does not improve cognitive function in epileptic patients. it is recommended that future studies consider longer course of trial, higher doses of selenium and measurement of serum levels of selenium. Key words: Selenium, Cognitive function , Epilepsy Yes - There is a plan to make this available What will be shared: The total data will be shared after removal of the pateint’s names. When: Starting6 months after publication the results. To whom: The data will only be available for academic institutions. Conditions: Different analysis will only be available for academic resarchers. Where to obtain: Dr mehdi maghbooli / m.maghbooli@zums..ac.ir .vali-e-asr square. Vali-e-asr hospital ,zanjan ,iran. phone number: 00982433770801postal code :4515777978 How to obtain: Email the requst for documents /within one week Comments:
public Mehdi maghbooli
Vali-e-asr squ,vali-e-asr hospital
Zanjan Iran (Islamic Republic of) 45157779978 +98 24 3377 0801 M.maghbooli@zums.ac.ir Zanjan University of Medical Sciences scientific Mehdi maghbooli
Vali-e-asr squ,vali-e-asr hospital
Zanjan Iran (Islamic Republic of) 4515777978 +98 982433770801 M.maghbooli@zums.ac.ir Zanjan University of Medical Sciences Iran (Islamic Republic of) Adult pateints between 20_60 year’s old suffering from idiopathic generelized epilepsy. Satisfaction for participation in the study. Patients who passed at least one year from onset of the epilepsy. Patients who haven't been changed their antiepileptic drugs from one month befot to the end of intervention. 20 years 60 years Both Patients who had seizure during one week ago. Moca score higher than 29. Pateints who suffer from major psychiatric disorders such as mood disorder, psychosis, mental retardation &... G40 Epilepsy and recurrent seizures Treatment - Drugs Placebo Intervention group: epileptic patients,tab selenium 200mcg ,one tabletin at breakfast for 4months ,21centry(purapakhsh)company included purified selenium; as an antioxidant. Control group: epileptic patients,tab selenium placebo 200mcg,one tab at breakfast ,for 4months,purapakhsh company. The epileptic patient’s cognitive status based on moca test. Timepoint: Moca test at the start of study,2month &4month later. Method of measurement: Moca test. Zanjan University of Medical Sciences Approved 2018-01-23 Ethic committee of zanjan university of medical siences. Vali-e-asr squ, vali-e-asr hospital,zanjan,iran Zanjan Zanjan Iran (Islamic Republic of)