Protocol summary
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Study aim
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Determining of effectiveness of selenium on cognitive function in epileptic patients.
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Design
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Two arm parallel group randomized trial with blinded postoperative care and outcome assessment.randomized allocation rule method was used.
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Settings and conduct
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Two blind randomized clinicsl trial will be done with 70patients who refered to the vali-e-asr zanjan hospital, then patients randomly divided inti two group of experimental and placebo group. all the patients, referral physician, stratification will not know about the type of drug.patients in experimental group will be given tab selenium 200mcg, and who are in placebo group, the tab placebo.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: patient with idiopathic generelized epilepsy between 20-60
Satisfaction for patcipation in the study.
Patiens who past at least 1year from the onset of the disease.
Patient who have not had changed their drug regime from one month to the end of intervention.
Exclusion criteria: patient who had seizure within one week ago.
Moca score more than 20
Presence of major psychiatric disease:depression, mood disorder, psychosis, mental retardation
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Intervention groups
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Experimental group (35patients)and placebo group(35patients), who in addition to main treatment of their disease receive selenium and placebo respectively for 4months.
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Main outcome variables
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Improvement in cognitive function
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20101209005352N3
Registration date:
2018-10-29, 1397/08/07
Registration timing:
registered_while_recruiting
Last update:
2019-02-03, 1397/11/14
Update count:
1
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Registration date
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2018-10-29, 1397/08/07
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-08-06, 1397/05/15
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Expected recruitment end date
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2019-02-20, 1397/12/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Effectiveness of selenium in epileptic patient’s cognitive function compared with control group
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Public title
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Selenium in epilepsy.
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
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.
Exclusion criteria:
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 &...
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Age
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From 20 years old to 60 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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Sample size
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Target sample size:
70
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-01-23, 1396/11/03
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Ethics committee reference number
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ZUMS.REC.1396.267
Health conditions studied
1
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Description of health condition studied
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Epilepsy
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ICD-10 code
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G40
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ICD-10 code description
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Epilepsy and recurrent seizures
Primary outcomes
1
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Description
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The epileptic patient’s cognitive status based on moca test.
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Timepoint
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Moca test at the start of study,2month &4month later.
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Method of measurement
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Moca test
Intervention groups
1
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Description
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Intervention group: epileptic patients,tab selenium 200mcg ,one tabletin at breakfast for 4months ,21centry(purapakhsh)company included purified selenium; as an antioxidant.
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Category
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Treatment - Drugs
2
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Description
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Control group: epileptic patients,tab selenium placebo 200mcg,one tab at breakfast ,for 4months,purapakhsh company.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Zanjan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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The total data will be shared after removal of the pateint’s names.
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When the data will become available and for how long
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Starting6 months after publication the results.
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To whom data/document is available
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The data will only be available for academic institutions.
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Under which criteria data/document could be used
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Different analysis will only be available for academic resarchers.
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From where data/document is obtainable
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Dr mehdi maghbooli / m.maghbooli@zums..ac.ir .vali-e-asr square. Vali-e-asr hospital ,zanjan ,iran. phone number: 00982433770801postal code :4515777978
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What processes are involved for a request to access data/document
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Email the requst for documents /within one week
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Comments
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