An investigation of the effect of Vitamin D3 on seizure attacks in the patients with drug-resistant epilepsy compared with the control group
Design
A randomized, single-blind, placebo-controlled, community-based clinical trial
Settings and conduct
This study is an analytical and single-blind clinical trial. It took place at Al-Zahra Medical Training Center from 2018 to 2019. Subjects of the present study were selected from patients with refractory epilepsy referred to educational hospitals and epilepsy clinics of Isfahan based on inclusion criteria. After preliminary tests, 116 patients were finally selected according to the study criteria. The control and control groups were 22 patients (11 males and 11 females respectively).
Participants/Inclusion and exclusion criteria
The inclusion criteria are drug resistant epilepsy and vitamin D deficiency, which is diagnosed on the basis of the doctor's opinion. Exclusion criteria are: Patients' unwillingness to continue to participate in research and other diseases that may cause problems in the research process.
Intervention groups
22 patients with refractory epilepsy received placebo at Isfahan Pharmacy School for 8 weeks and once a week and 22 patients with refractory epilepsy treated with Pearl Vitamin D3 for 50 weeks. They were assigned once a week.
Main outcome variables
The effect of vitamin D3 on the control of drug-resistant epileptic seizures was investigated.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130730014217N2
Registration date:2020-02-22, 1398/12/03
Registration timing:retrospective
Last update:2020-02-22, 1398/12/03
Update count:0
Registration date
2020-02-22, 1398/12/03
Registrant information
Name
Mohammad Reza Najafi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3627 3910
Email address
najafi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-04, 1397/01/15
Expected recruitment end date
2019-03-11, 1397/12/20
Actual recruitment start date
2018-10-22, 1397/07/30
Actual recruitment end date
2019-04-04, 1398/01/15
Trial completion date
2019-08-21, 1398/05/30
Scientific title
Effect of Vitamin D3 on seizure attacks in the patients with drug-resistant epilepsy compared with the control group
Public title
The efficacy of Vitamin D3 on seizure attacks in the patients with drug-resistant epilepsy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
drug-resistant epilepsy to treatment
No other disease
Vitamin D3 deficiency
Adult population over 18 years.
Exclusion criteria:
Patient's unwillingness and conscious dissatisfaction
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Actual sample size reached:
44
Randomization (investigator's opinion)
Randomized
Randomization description
The simple randomized blocking method was performed among patients with epilepsy referred to teaching hospitals and epilepsy clinics in Isfahan individually. SPSS software was used for this purpose.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients were first invited and interviewed about the research and written consent was obtained. Patients were unaware of which group they were in, and they only took the prescribed medication. But the researcher knew which patient group he was in.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Ethics Committee of Isfahan University of Medical Sciences, Isfahan University of Medical Sciences, Hezar jrib street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
7346181746
Approval date
2017-03-02, 1395/12/12
Ethics committee reference number
IR.MUI.REC.1395.3.015
Health conditions studied
1
Description of health condition studied
drug-resistant epilepsy
ICD-10 code
G40.211
ICD-10 code description
Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with complex partial seizures, intractable, with status epilepticus
Primary outcomes
1
Description
number of seizures
Timepoint
At beginning and 1, 2 and 3 months after treatment, patients were visited and the number and duration of seizures occurred.
Method of measurement
Blood test and evaluation of 25OH vitamin D
Secondary outcomes
empty
Intervention groups
1
Description
Control group: 22 patients with refractory epilepsy who received placebo at the Faculty of Pharmacy of Isfahan for 8 weeks and once a week.
Category
Placebo
2
Description
Intervention group: Twenty-two patients with refractory epilepsy who were treated with Pearl Vitamin D3 for fifty thousand units weekly for 8 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Mohammadreza Najafi
Street address
Sofe Bolvar
City
Esfahan
Province
Isfehan
Postal code
81746775731
Phone
+98 31 3620 2020
Email
alzahra@mui.ac.ir
Web page address
http://alzahra.mui.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammadreza Najafi
Street address
Hezarjarib ST.
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
najafi@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
80
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
Esfahan University of Medical Sciences
Full name of responsible person
Mohammadreza Najafi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Daneshgah
City
Esfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3627 3910
Fax
+98 31 3627 3910
Email
najafi@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammadreza Najafi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Daneshgah
City
Esfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3627 3910
Email
najafi@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammadreza Najafi
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Daneshgah
City
Esfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3627 3910
Email
najafi@med.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Patients' personal information.
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The results of the analysis are shared with the reduction of seizures after vitamin D3 administration.
When the data will become available and for how long
Starting access after printing results
To whom data/document is available
Everyone can access the results of data analysis.
Under which criteria data/document could be used
Everyone can access the results of data analysis.
From where data/document is obtainable
Journal site
What processes are involved for a request to access data/document