Assessment of the effectiveness of vitamin D in treatment of patients with allergic rhinitis
Design
Clinical trial with control group, community-based and pragmatic with parallel groups, double blinded, and Phase 3 trials Randomized with table numbers, and design of 56 patients
Settings and conduct
This study was performed on 56 patients referred to the clinic of Ghaem Hospital in Mashhad. It was single-centered and double-blinded. Patients, researchers and analyst were blinded.
Participants/Inclusion and exclusion criteria
•Inclusion criteria: Patients with allergic rhinitis, which have been diagnosed by an immunologist with pric test.
Having vitamin D deficiency
Have consent to participate in the study
•Exclusion criteria: Pregnancy
Immunodeficiency diseases
Sensitization to prescription drug
Intervention groups
In the intervention group, an allergic rhinitis routine treatment containing antihistamines will be taken with perl vitamin D for 8 weeks.
In the control group, in addition to routine treatment containing antihistamines, they will receive placebo for 8 weeks.
Main outcome variables
Allergic rhinits Symptoms on the basis of Questionnaire
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180217038763N2
Registration date:2019-02-06, 1397/11/17
Registration timing:registered_while_recruiting
Last update:2019-02-06, 1397/11/17
Update count:0
Registration date
2019-02-06, 1397/11/17
Registrant information
Name
mehdi bakhshaee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3841 3492
Email address
mehbakhsh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2019-05-22, 1398/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of vitamin D efficacy in the patients with Allergic rhinitis in comparison with control group
Public title
The Efficacy of vitamin D in treating patients with nasal congestion
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with allergic rhinitis
Conscious Consent
Exclusion criteria:
Use of other drugs in addition to prescription drugs
Having vitamin D deficiency
Pregnant and infected people with immunodeficiency and skin diseases
Having allergies to prescription drugs
Age
From 6 years old to 40 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
Blocked randomization method using random numbers table using www.randomization.com
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants and researchers will be unaware of the intervention and control groups
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Ghoreishi building, Daneshgah AVE
City
Mashhad
Province
Razavi Khorasan
Postal code
91778-99191
Approval date
2018-12-12, 1397/09/21
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1397.459
Health conditions studied
1
Description of health condition studied
Allergic rhinitis
ICD-10 code
J30.9
ICD-10 code description
Allergic rhinitis, unspecified
Primary outcomes
1
Description
Clinical symptoms of Allergic rhinitis
Timepoint
At the beginning of the study, and weeks 4 and 8, after starting taking vitamin D
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine treatment of allergic rhinitis include antihistamines with Perl D vitamin will be received for 8 weeks
Category
Treatment - Other
2
Description
Control group: In the control group, in addition to routine treatment, they will receive placebo for 8 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Mehdi Bakhshaei
Street address
Ahmad abad AVE, Ghaem hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3801 2753
Email
Mehbakhsh@yahoo.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
Ghoreishi building, Daneshgah AVE
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3841 3492
Email
ramresearch@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
Fereshteh Esmati nia
Position
Non-faculty specialist
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Ghaem Hospital, Ahmad Abad AVE
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3841 3492
Email
f.esmatinia@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mehdi Bakhshaee
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Ghaem Hospital, Ahmad Abad AVE
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3841 3492
Email
mehbakhsh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mehdi Bakhshaee
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Ghaem Hospital, Ahmad Abad AVE
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3841 3492
Email
mehbakhsh@yahoo.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