Determine the therapeutic effect of vitamin D in patients with sinusonal polyposis
Design
A clinical trial with a control group with parallel double-blind, randomized, and enveloped groups
Settings and conduct
This study was conducted on 60 patients in the ENT department of Imam Reza Hospital and Ghaem Hospital in Mashhad, Iran.
The blinding is carried out and the patients , researcher alsoanalyzer were blinded and closed envelope has been used.
Participants/Inclusion and exclusion criteria
There is a lack of vitamin D and no chronic disease (which is likely to affect serum vitamin A levels or absorption and excretion), no smoking, no history of supplementing vitamin D in the last three months.
Intervention groups
Control group: A group receiving vitamin D1,000 units as 1 healthy min Capsule per day.
Intervention group: A group that receives 5,000 units of vitamin D in 5 healthy min capsules per day.
Main outcome variables
Improvement of Sinonazal Polyposis Symptoms on the basis of Questionnaire
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180217038763N1
Registration date:2018-03-19, 1396/12/28
Registration timing:registered_while_recruiting
Last update:2018-03-19, 1396/12/28
Update count:0
Registration date
2018-03-19, 1396/12/28
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
2017-08-23, 1396/06/01
Expected recruitment end date
2018-05-22, 1397/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study the effect of vitamin D on the treatment of patients with sinusonal polyposis
Public title
Study the effect of vitamin D on nasal polyps
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Lack of serum vitamin D levels
Patients satisfaction
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Normal randomization method with Closed envelope.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients give informed consent, but patients don't know whether they are in placebo group or the original drug group, also researcher don't know whether Patients are members of which group and the only aware person is analyzer.
Placebo
Not 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
Ghaem Hospital, Ahmad Abad AVE
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Approval date
2017-12-27, 1396/10/06
Ethics committee reference number
IR.MUMS.fm.REC.1396.535
Health conditions studied
1
Description of health condition studied
sinunasal polyposis
ICD-10 code
J33.8
ICD-10 code description
Other polyp of sinus
Primary outcomes
1
Description
Improvement of Sinonazal Polyposis Symptoms on the basis of Questionnaire
Timepoint
At the beginning of the study and 8 weeks after starting the use of vitamin D capsules
Method of measurement
Lund-kennedy questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Patients in this group receive 1 x Healthy min capsule per day (vitamin D1000 unit of Minoo Pharmaceutical Company) for 8 weeks.
Category
Treatment - Drugs
2
Description
Intervention group: Patients in this group receive 5 x Healthy min capsule per day (vitamin D5000 unit of Minoo Pharmaceutical Company) for 8 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
سعید حسینی
Street address
Ghaem Hospital, Ahmad Abad AVE
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3841 3492
Email
saeed11848@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 2081
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
سعید حسینی
Position
specialist
Latest degree
Specialist
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
saeed11848@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
bakhshaeem@mums.ac.ir
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
bakhshaeem@mums.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