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The effect of vitamin D on pulmonary function and serum level of interleukin 10 and antioxidant activity in patient with moderate to severe asthma.

Protocol summary

Study aim
Determining the effect of vitamin D administration on lung function and serum level of interleukin 10 and total serum antioxidant activity in patients with moderate to severe asthma with vitamin D deficiency
Design
Clinical trial with control group, with parallel group; Double-blind, randomized
Settings and conduct
This study is performed in Valiasr Hospital in Birjand, South Khorasan Province. Sixty patients are randomly divided into intervention and control groups. At the beginning of the study and before starting treatment, antioxidant activity and interleukin 10 were evaluated from serum levels. Then the intervention was performed for 3 months. Blood samples were taken from patients and antioxidant and interleukin 10 parameters were measured. In this study, the executive steps were performed by the administrator and the patients and the evaluating nurse did not know the patient group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: including people with moderate to severe asthma without association with systemic, heart, liver, infectious, diabetes and kidney diseases referred to Vali-e-Asr Hospital for outpatient treatment and exclusion criteria: Reluctance to cooperate in the continuation of the project, presence of disease including diabetes mellitus, CAD, CKD, PTE and bacterial pneumonia, death, non-medication, changes in treatment, addition of other disease as well as patients taking antioxidant supplement or medication and any medication that affects the mitochondrial system and antioxidant storage.
Intervention groups
The intervention group consisted of 30 patients with asthma who received 1 pearl 2,000 units of vitamin D daily for 3 months. The control group consisted of 30 patients with asthma who received 1 pearl containing glucose 1 daily for 3 months.
Main outcome variables
Total Antioxidant Capacity Interleukin 10

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190721044288N1
Registration date: 2020-10-27, 1399/08/06
Registration timing: retrospective

Last update: 2020-10-27, 1399/08/06
Update count: 0
Registration date
2020-10-27, 1399/08/06
Registrant information
Name
Ali Mirshahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3871 5553
Email address
dr.ali.mirshahi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-19, 1398/01/30
Expected recruitment end date
2019-10-22, 1398/07/30
Actual recruitment start date
2019-04-19, 1398/01/30
Actual recruitment end date
2020-01-20, 1398/10/30
Trial completion date
2020-02-19, 1398/11/30
Scientific title
The effect of vitamin D on pulmonary function and serum level of interleukin 10 and antioxidant activity in patient with moderate to severe asthma.
Public title
Effect of vitramin D in asthma
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
moderate to severe asthma treated with inhaled corticosteroid (ICS) vitamin D deficiency No systemic disease No diabetes No infectious disease No liver disease No heart disease No kidney disease
Exclusion criteria:
patient expired patient who do not use his drug add new systemic disease change of treatment Patients taking antioxidant drugs Use of any medication that affects the mitochondrial system and antioxidant storage
Age
From 16 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 60
Actual sample size reached: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random lottery method
Blinding (investigator's opinion)
Double blinded
Blinding description
Study participants were not aware of the drug used. The control group also received placebo of the same shape, color and size as the intervention group drug. The outcome assessor (co-nurse) assessed the outcome without informing the patient group.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Birjand University of Medical Sciences
Street address
Ghaffari Str
City
Birjand
Province
South Khorasan
Postal code
9717811674
Approval date
2018-10-29, 1397/08/07
Ethics committee reference number
ir.bums.REC.1397.185

Health conditions studied

1

Description of health condition studied
Asthma
ICD-10 code
J45
ICD-10 code description
Asthma

Primary outcomes

1

Description
Serum levels of antioxidants in the blood serum of patients
Timepoint
Measurement of serum antioxidant levels at the beginning of the study and 3 months after starting vitamin D intake
Method of measurement
Use of thiobarbituric acid method

2

Description
Serum levels of interleukin 10 in the blood serum of patients
Timepoint
Measurement of serum interleukin level 10 at the beginning of the study and 3 months after starting vitamin D intake
Method of measurement
Using the commercial kit by ELISA method

Secondary outcomes

empty

Intervention groups

1

Description
Control group: received 1 pearl containing glucose daily (made by Birjand School of Pharmacy) as a placebo for 3 months.
Category
Placebo

2

Description
Intervention group: received 1 unit of pearl vitamin D 2000 units (manufactured by Dana Pharmaceutical Company) daily for 3 months.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Valiasr Hospital, Birjand
Full name of responsible person
Dr. Ali Mirshahi
Street address
Moallem Str
City
Birjand
Province
South Khorasan
Postal code
9717811674
Phone
+98 56 3232 3232
Email
oabstudent@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr. Tooba Kazemi
Street address
Ghaffari Str
City
Birjand
Province
South Khorasan
Postal code
9717811674
Phone
+98 56 3238 1200
Email
oabstudent@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand University of Medical Sciences
Proportion provided by this source
50
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
Birjand University of Medical Sciences
Full name of responsible person
Zabihullah Mohaghegh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
General Practitioner
Street address
Moallem Str
City
Birjand
Province
South Khorasan
Postal code
9717811674
Phone
+98 56 3232 3232
Email
oabstudent@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Mortazavimoghaddam
Position
Faculty of member
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Ghaffari Str
City
Birjand
Province
South Khorasan
Postal code
9717811674
Phone
+98 56 3232 3232
Email
oabstudent@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr. Ali Mirshahi
Position
Resident of Internal Studies
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Moallem Str
City
Birjand
Province
South Khorasan
Postal code
9717811674
Phone
+98 56 3232 3232
Email
oabstudent@gmail.com

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
There are no plans to publish it
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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