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Effect of vitamin D on serum levels of CHI3L1 inflammatory factor and oxidative stress in patients with multiple sclerosis: a before-after clinical trial

Protocol summary

Study aim
To assess the effect of vitamin D on serum levels of CHI3L1 inflammatory factor and oxidative stress in patients with multiple sclerosis
Design
This is a before-after clinical trial without control group, phase III in which 35 patients with multiple sclerosis will be enrolled. Blinding is not possible in this study
Settings and conduct
This study will be performed in the Besat Hospital in Hamadan city on 35 eligible patients with multiple sclerosis. This is a before-after clinical trial therefore blinding is not possible in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age of 18 to 65 years Women with multiple sclerosis Exclusion criteria: Acute infection Diabetes Rheumatoid diseases Kidney dysfunction Malabsorption Autoimmune diseases
Intervention groups
Intervention group: Oral vitamin D3 supplement with a dose of 50,000 units once a week for 8 weeks
Main outcome variables
Primary outcome: CHI3L1 serum level, serum level of oxidative stress factors

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120215009014N473
Registration date: 2023-05-11, 1402/02/21
Registration timing: prospective

Last update: 2023-05-11, 1402/02/21
Update count: 0
Registration date
2023-05-11, 1402/02/21
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-22, 1402/03/01
Expected recruitment end date
2023-07-23, 1402/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of vitamin D on serum levels of CHI3L1 inflammatory factor and oxidative stress in patients with multiple sclerosis: a before-after clinical trial
Public title
Effect of vitamin D on serum levels of CHI3L1 inflammatory factor and oxidative stress in patients with multiple sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 65 years Women with multiple sclerosis
Exclusion criteria:
Acute infection Diabetes Rheumatoid diseases Kidney dysfunction Malabsorption Autoimmune diseases
Age
From 18 years old to 65 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 35
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2023-02-05, 1401/11/16
Ethics committee reference number
IR.UMSHA.REC.1401.984

Health conditions studied

1

Description of health condition studied
Multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis

Primary outcomes

1

Description
CHI3L1 serum level
Timepoint
Before the intervention and 8 weeks later
Method of measurement
Using ELISA kit

2

Description
Serum level of oxidative stress factors
Timepoint
Before the intervention and 8 weeks later
Method of measurement
Using ELISA kit

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Oral vitamin D3 supplement with a dose of 50,000 units once a week for 8 weeks
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Besat Hospital in Hamadan city
Full name of responsible person
Sevda Asadpour
Street address
Besat Hospital, Shahed Square
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
sevda.asadpour@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Reza Shokoohi
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Sevda Asadpour
Position
Biochemistry Student
Latest degree
Master
Other areas of specialty/work
Biochemistry
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
sevda.asadpour@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Gholam Reza Shafiee
Position
Biochemist
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
g.r_shafiee@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
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