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Trial results
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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
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
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عنوان طرح : بررسی اثربخشی مکمل سلنیوم بر عملکرد شناختی بیماران مصروع
مقدمه : صرع یک مشکل سلامتی در انسان می باشند و بعد از انواع سکته های مغزی، یک اختلال نورولوژیک شایع در انسان است. مشکلات شناختی در بیماران مصروع به وفور دیده شده که علل آن متعدد است از جمله ضایعات مغزی، فرکانس تشنج ها،نوع درمان،صرع مزمن وشدید و پلی تراپی. شواهدی وجود دارد که اختلال شناختی از ابتدای بیماری وجود دارد.بر اساس مطالعات سلنیوم با کاهش استرس اکسیداتیو در عملکرد شناختی می تواند موثر باشد. این مطالعه با هدف بررسی اثربخشی مکمل سلنیوم بر عملکرد شناختی بیماران مصروع انجام گرفت.
روش بررسي : در این کارآزمایی بالینی ۷۰بیمار با صرع ژنرالیزه تونیک کلونیک ایدیوپاتیک با روش تصادفی ساده یک سویه کور انتخاب و به دو گروه تجربی و کنترل تقسیم شدند. قبل از شروع درمان ارزیابی عملکرد شناختی بیماران با تست موکا صورت گرفت. سپس گروه مورد کپسول سلنیوم ۲۰۰میکروگرم و گروه شاهد پلاسبو دریافت کردند. دو ماه پس از درمان و پایان ماه چهار مجددا ارزیابی با تست موکا صورت گرفت. سپس به مقایسه اثر دارو و پلاسبو بر عملکرد شناختی بیماران پرداختیم. آنالیز داده ها با استفاده از نرم افزار آماری SPSS نسخه 24 انجام شد واز آزمونهای تی مستقل و کای اسکوار جهت مقایسه بین گروه ها استفاده شد.
نتايج : در این مطالعه ۷۰ بیمار مصروع مبتلا به صرع ژنرالیزه تونیک کلونیک ایدیوپاتیک در گروه سنی۲۰تا ۶۵ سال در دو گروه تجربی (۳۵ نفر) و پلاسبو (۳۵ نفر) مورد بررسی قرار گرفتند. میانگین امتیاز تست موکا دو ماه بعد از درمان در گروه پلاسبو ۲۴/۴۹(ماکزیمم ۳۰و مینیمم ۱۹)بود و در گروه تجربی میانگین تست موکا بعد از دو ماه درمان ۲۴/۹۱(ماکزیمم ۳۰و مینیمم ۱۶)بود. چهار ماه بعد از درمان با اتمام طرح میانگین امتیاز تست موکا در گروه پلاسبو ۲۴/۵۴(ماکزیمم ۳۰و مینیمم ۱۹)بود و در گروه درمان میانگین امتیاز تست موکا ۲۶/۳۱(ماکزیمم ۳۰و مینیمم ۱۶) بود.درنتیجه اختلاف معنی داری از نظر عملکرد شناختی بین دو گروه مشاهده نگردید.
نتیجه گیری و پیشنهادات: نتایج حاصل از مطالعه ما نشان داد که مکمل سلنیوم با عملکرد شناختی در بیماران مصروع ارتباطی نداشت.
پیشنهاد می گردد مطالعاتی با طراحی مبتنی بر افزایش مدت زمان طرح،اخذ نمونه خون از بیماران جهت بررسی سطح سرمی سلنیوم قبل و بعد از اتمام طرح و تجویز دوز بالاتر سلنیوم صورت گیرد.
واژه هاي كليدي : سلنیوم، عملکرد شناختی، صرع
عنوان طرح : بررسی اثربخشی مکمل سلنیوم بر عملکرد شناختی بیماران مصروع مقدمه : صرع یک مشکل سلامتی در انسان می باشند و بعد از انواع سکته های مغزی، یک اختلال نورولوژیک شایع در انسان است. مشکلات شناختی در بیماران مصروع به وفور دیده شده که علل آن متعدد است از جمله ضایعات مغزی، فرکانس تشنج ها،نوع درمان،صرع مزمن وشدید و پلی تراپی. شواهدی وجود دارد که اختلال شناختی از ابتدای بیماری وجود دارد.بر اساس مطالعات سلنیوم با کاهش استرس اکسیداتیو در عملکرد شناختی می تواند موثر باشد. این مطالعه با هدف بررسی اثربخشی مکمل سلنیوم بر عملکرد شناختی بیماران مصروع انجام گرفت. روش بررسي : در این کارآزمایی بالینی ۷۰بیمار با صرع ژنرالیزه تونیک کلونیک ایدیوپاتیک با روش تصادفی ساده یک سویه کور انتخاب و به دو گروه تجربی و کنترل تقسیم شدند. قبل از شروع درمان ارزیابی عملکرد شناختی بیماران با تست موکا صورت گرفت. سپس گروه مورد کپسول سلنیوم ۲۰۰میکروگرم و گروه شاهد پلاسبو دریافت کردند. دو ماه پس از درمان و پایان ماه چهار مجددا ارزیابی با تست موکا صورت گرفت. سپس به مقایسه اثر دارو و پلاسبو بر عملکرد شناختی بیماران پرداختیم. آنالیز داده ها با استفاده از نرم افزار آماری SPSS نسخه 24 انجام شد واز آزمونهای تی مستقل و کای اسکوار جهت مقایسه بین گروه ها استفاده شد. نتايج : در این مطالعه ۷۰ بیمار مصروع مبتلا به صرع ژنرالیزه تونیک کلونیک ایدیوپاتیک در گروه سنی۲۰تا ۶۵ سال در دو گروه تجربی (۳۵ نفر) و پلاسبو (۳۵ نفر) مورد بررسی قرار گرفتند. میانگین امتیاز تست موکا دو ماه بعد از درمان در گروه پلاسبو ۲۴/۴۹(ماکزیمم ۳۰و مینیمم ۱۹)بود و در گروه تجربی میانگین تست موکا بعد از دو ماه درمان ۲۴/۹۱(ماکزیمم ۳۰و مینیمم ۱۶)بود. چهار ماه بعد از درمان با اتمام طرح میانگین امتیاز تست موکا در گروه پلاسبو ۲۴/۵۴(ماکزیمم ۳۰و مینیمم ۱۹)بود و در گروه درمان میانگین امتیاز تست موکا ۲۶/۳۱(ماکزیمم ۳۰و مینیمم ۱۶) بود.درنتیجه اختلاف معنی داری از نظر عملکرد شناختی بین دو گروه مشاهده نگردید. نتیجه گیری و پیشنهادات: نتایج حاصل از مطالعه ما نشان داد که مکمل سلنیوم با عملکرد شناختی در بیماران مصروع ارتباطی نداشت. پیشنهاد می گردد مطالعاتی با طراحی مبتنی بر افزایش مدت زمان طرح،اخذ نمونه خون از بیماران جهت بررسی سطح سرمی سلنیوم قبل و بعد از اتمام طرح و تجویز دوز بالاتر سلنیوم صورت گیرد. واژه هاي كليدي : سلنیوم، عملکرد شناختی، صرع
Protocol summary
Study aim
Determining of effectiveness of selenium on cognitive function in epileptic patients.
Design
Two arm parallel group randomized trial with blinded postoperative care and outcome assessment.randomized allocation rule method was used.
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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
Intervention groups
Experimental group (35patients)and placebo group(35patients), who in addition to main treatment of their disease receive selenium and placebo respectively for 4months.
Main outcome variables
Improvement in cognitive function
General information
Reason for update
Acronym
IRCT registration information
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
Registration date
2018-10-29, 1397/08/07
Registrant information
Name
Mehdi Maghbooli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3347 2576
Email address
m.maghbooli@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-06, 1397/05/15
Expected recruitment end date
2019-02-20, 1397/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of selenium in epileptic patient’s cognitive function compared with control group
Public title
Selenium in epilepsy.
Purpose
Supportive
Inclusion/Exclusion criteria
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 &...
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Single blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of zanjan university of medical siences.
Street address
Vali-e-asr squ, vali-e-asr hospital,zanjan,iran
City
Zanjan
Province
Zanjan
Postal code
451577978
Approval date
2018-01-23, 1396/11/03
Ethics committee reference number
ZUMS.REC.1396.267
Health conditions studied
1
Description of health condition studied
Epilepsy
ICD-10 code
G40
ICD-10 code description
Epilepsy and recurrent seizures
Primary outcomes
1
Description
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
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: epileptic patients,tab selenium 200mcg ,one tabletin at breakfast for 4months ,21centry(purapakhsh)company included purified selenium; as an antioxidant.
Category
Treatment - Drugs
2
Description
Control group: epileptic patients,tab selenium placebo 200mcg,one tab at breakfast ,for 4months,purapakhsh company.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Vali-e-asr hospital
Full name of responsible person
Rosa davallou
Street address
Vali-e-ast squ,vali-e-asr hospital
City
Zanjan
Province
Zanjan
Postal code
4515777978
Phone
+98 24 3377 0801
Email
Dr_rosadavallou@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr.alireza shoghli
Street address
Vali-e-asr squ , vali-e-asr hospital,zanjan
City
Zanjan
Province
Zanjan
Postal code
4515777978
Phone
+98 24 3377 0801
Email
Dr_rosadavallou@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Mehdi maghbooli
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Vali-e-asr squ,vali-e-asr hospital
City
Zanjan
Province
Zanjan
Postal code
45157779978
Phone
+98 24 3377 0801
Email
M.maghbooli@zums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Mehdi maghbooli
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Vali-e-asr squ,vali-e-asr hospital
City
Zanjan
Province
Zanjan
Postal code
4515777978
Phone
+98 982433770801
Email
M.maghbooli@zums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Mehdi maghbooli
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Vali-e-asrsqu,vali-e-asr hospital
City
Zanjan
Province
Zanjan
Postal code
4515777978
Phone
+98 982433770801
Email
M.maghbooli@zums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The total data will be shared after removal of the pateint’s names.
When the data will become available and for how long
Starting6 months after publication the results.
To whom data/document is available
The data will only be available for academic institutions.
Under which criteria data/document could be used
Different analysis will only be available for academic resarchers.
From where data/document is obtainable
Dr mehdi maghbooli / m.maghbooli@zums..ac.ir .vali-e-asr square. Vali-e-asr hospital ,zanjan ,iran. phone number: 00982433770801postal code :4515777978
What processes are involved for a request to access data/document