The Effect of Supplements Containing Vitamin D and Selenium to Asthma Treatment on Symptoms and Immunological Alterations in Patients with Moderate to Severe Asthma
The effect of vitamin D, folic Acid, selenium, zinc, and copper supplements was investigated in patients with moderate to severe asthma.
Design
In this phase 2 parallel non-probability purposive sampling method study, 65 patients were divided not randomly in two groups. The first group was treated by 1200 IU of vitamin D3 daily and the second group was treated by 10 ml of Asmavit syrup daily for two months.
Settings and conduct
In this study 65 patients were divided into two groups by non-probability purposive sampling method: The first group was treated by 1200 IU of vitamin D3 daily and the second group was treated by 10 ml of Asmavit syrup (Vitabiotics Company, England) daily for two months.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- Patients with moderate to severe asthma according to the criteria adopted to determine the severity of the disease.
2- Age above 6 years.
3- patients satisfaction
Exclusion criteria:
1- Pregnancy
2- Unstable asthma
Intervention groups
The first group was treated by 1200 IU of vitamin D3 daily and the second group was treated by 10 ml of Asmavit syrup daily for two months.
Main outcome variables
Clinical symptoms and Immunological Alterations
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150716023235N16
Registration date:2020-09-04, 1399/06/14
Registration timing:registered_while_recruiting
Last update:2020-09-04, 1399/06/14
Update count:0
Registration date
2020-09-04, 1399/06/14
Registrant information
Name
Farahzad Jabbari Azad
Name of organization / entity
Allergy Research Center, Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1801 2770
Email address
jabbarif@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-20, 1399/02/01
Expected recruitment end date
2020-09-22, 1399/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Supplements Containing Vitamin D and Selenium to Asthma Treatment on Symptoms and Immunological Alterations in Patients with Moderate to Severe Asthma
Public title
The Effect of Vitamin D and Selenium Supplements
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with moderate to severe asthma according to the criteria adopted to determine the severity of the disease.
Age above 6 years
patients satisfaction
Exclusion criteria:
Pregnancy
Unstable asthma
Age
From 6 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
65
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences
Street address
Ghoreishi building Ethics Committee of Mashahd University of Medical Science
City
Mashhad
Province
Razavi Khorasan
Postal code
9175711111
Approval date
2014-10-25, 1393/08/03
Ethics committee reference number
IR.MUMS.REC.1393.178
Health conditions studied
1
Description of health condition studied
Patients with Moderate to Severe Asthma
ICD-10 code
J45
ICD-10 code description
Asthma
Primary outcomes
1
Description
Clinical symptoms
Timepoint
before and after intervention
Method of measurement
ACT and ACQ questionnaire
2
Description
Immunological Alterations
Timepoint
before and after intervention
Method of measurement
Elisa
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The first group was treated by 1200 IU of vitamin D3 daily for two months.
Category
Treatment - Drugs
2
Description
Intervention group: the second group was treated by 10 ml of Asmavit syrup (Vitabiotics Company, England) daily for two months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Allergy clinic of Ghaem Hospital
Full name of responsible person
Mansoor Ahoon
Street address
Ahmad abad AVE, Ghaem hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
91766-9919
Phone
+98 51 3801 2780
Email
dr.m.ahoon@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Ahmad Abad Boulevard, Ghaem Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
91766-9919
Phone
+98 51 3841 2081
Email
tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Mansoor Ahoon
Position
Subspeciality
Latest degree
Medical doctor
Other areas of specialty/work
Immunology
Street address
No. 7, Bokharaei 11 St., Ahmad Abad ave.,Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9183847000
Phone
+98 51 3846 7298
Email
dr.m.ahoon@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mansoor Ahoon
Position
Subspeciality
Latest degree
Medical doctor
Other areas of specialty/work
Immunology
Street address
No. 7, Bokharaei 11 St., Ahmad Abad ave., Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9183847000
Phone
+98 51 3846 7298
Email
dr.m.ahoon@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mansoor Ahoon
Position
Subspeciality
Latest degree
Medical doctor
Other areas of specialty/work
Immunology
Street address
No. 7, Bokharaei 11 St., Ahmad Abad ave., Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9183847000
Phone
+98 51 3846 7298
Email
dr.m.ahoon@gmail.com
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