Evaluation the treatment effect of vitamin D deficiency on the improvement of dry eye
Design
Randomized clinical trial with parallel groups in 100 patients
Settings and conduct
Among patients referred to Khatam Alanbia hospital, 100 cases who were suffering simultaneously from Vit D deficiency (serum Vit D level below 20 ng/ml) and dry eye which is defind by schirmer, tear breakup time and tear lab test is selected.
These patients then was randomly categorized in to two groups, case and cnotrol group.
The case group is treated with 50000 units Vit D weekly until the serum Vit D level become normal and reaches levels more than 20 ng/ml. Both groups get similar dry eye treatment.
After treating Vit D deficiency in case control, dry eye assesment is done again and the results will be compare between two groups in order to evaluate the vit d deficiency on dry eye.
Participants/Inclusion and exclusion criteria
Inclusion criterion: dry eye and vitamin D deficiency.
exclusion criteria: any history of eye surgery or disease(except dry eye); intake of vitamin D.
Intervention groups
Intervention group: treatment of vitamin D deficiency with pearl 50000 u vitamin D per week until 8 weeks.
Control group: routine treatment of dry eye with artificial tear drop.
Main outcome variables
Schirmer test; tear breakup time test; tear osmolarity; serum level of vitamin D
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190407043184N1
Registration date:2019-11-23, 1398/09/02
Registration timing:prospective
Last update:2019-11-23, 1398/09/02
Update count:1
Registration date
2019-11-23, 1398/09/02
Registrant information
Name
Ehsan Arjmand askari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3728 1401
Email address
arjmandae941@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-26, 1398/09/05
Expected recruitment end date
2020-01-25, 1398/11/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the treatment effect of vitamin D deficiency on the improvement of dry eye
Public title
Evaluation the treatment effect of vitamin D deficiency on the improvement of dry eye
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Dry eye and vitamin D deficiency
Exclusion criteria:
Any history of eye surgery or disease(except dry eye)
Intake of vitamin D
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
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
Ethics committee of mashhad University of Medical Sciences
Street address
mashhad.aboutaleb cross.khatam olanbiae hospital
City
mashhad
Province
Razavi Khorasan
Postal code
۹۱۹۶۶۴۳۶۴۶
Approval date
2017-08-09, 1396/05/18
Ethics committee reference number
Ir.mums.fm.rec.1396.254
Health conditions studied
1
Description of health condition studied
Dry eye syndrome
ICD-10 code
H04.1
ICD-10 code description
Dry eye syndrome
Primary outcomes
1
Description
Schirmer test
Timepoint
Measurment of schirmer test at baseline and 8 weeks after the intervention
Method of measurement
With schirmer paper
2
Description
Tear breakup time test
Timepoint
Measurment of Tear breakup time test at baseline and 8 weeks after the intervention
Method of measurement
With fluorescein paper and slit lamp and no anesthetics
3
Description
Tear osmolarity
Timepoint
Measurment of tear osmolarity at baseline and 8 weeks after the intervention
Method of measurement
With Tearlab osmolarity system
4
Description
Serum level of vitamin D
Timepoint
Measurment of serum level of vitamin D at baseline and 8 weeks after the intervention
Method of measurement
Vitamin D blood test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: treatment of vitamin D deficiency with pearl 50000 u vitamin D per week until 8 weeks
Category
Treatment - Drugs
2
Description
Control group: routine treatment of dry eye with artificial tear drop
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatam al anbia hospital
Full name of responsible person
Ehsan arjmand askari
Street address
Aboutaleb cross.khatam al anbia hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
۹۱۹۶۶۴۳۶۴۶
Phone
+98 51 3728 1401
Email
Arjmandae941@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Saeid eslami
Street address
ghoreyshi building, daneshgah ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9195965919
Phone
+98 51 3845 2474
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
Ehsan Arjmand Askari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
Abutaleb cross; Khatam al Anbia hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9196643646
Phone
+98 51 3728 1401
Fax
Email
arjmandae941@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ehsan Arjmand Askari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
Abutaleb cross; Khatamol Anbia hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9196643646
Phone
+98 51 3728 1401
Fax
Email
arjmandae941@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ehsan Arjmand Askari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
Abutaleb cross; Khatam al Anbia hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9196643646
Phone
+98 51 3728 1401
Fax
Email
arjmandae941@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Any detail going to published
When the data will become available and for how long
6 months after validity
To whom data/document is available
Any scientific and collegiate institutions
Under which criteria data/document could be used
Any analusis allowed
From where data/document is obtainable
Arjmandae941@mums.ac.ir
What processes are involved for a request to access data/document