Protocol summary
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Study aim
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Evaluation the treatment effect of vitamin D deficiency on the improvement of dry eye
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Design
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Randomized clinical trial with parallel groups in 100 patients
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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Inclusion criterion: dry eye and vitamin D deficiency.
exclusion criteria: any history of eye surgery or disease(except dry eye); intake of vitamin D.
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Intervention groups
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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.
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Main outcome variables
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Schirmer test; tear breakup time test; tear osmolarity; serum level of vitamin D
General information
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Reason for update
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Correction of the mistake made in the section on randomization in the general information section, considering that in the abstract section, the type of randomized clinical trial study was previously mentioned correctly.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20190407043184N1
Registration date:
2019-11-23, 1398/09/02
Registration timing:
prospective
Last update:
2020-12-19, 1399/09/29
Update count:
1
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Registration date
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2019-11-23, 1398/09/02
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-11-26, 1398/09/05
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Expected recruitment end date
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2020-01-25, 1398/11/05
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Evaluation the treatment effect of vitamin D deficiency on the improvement of dry eye
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Public title
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Evaluation the treatment effect of vitamin D deficiency on the improvement of dry eye
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Dry eye and vitamin D deficiency
Exclusion criteria:
Any history of eye surgery or disease(except dry eye)
Intake of vitamin D
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Age
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No age limit
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
100
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Random allocation
We poured 100 balls containing the names of the people who met the inclusion criteria into a lottery tank and the first 50 balls that came out as the intervention group and the remaining 50 balls as the control group entered in to study.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2017-08-09, 1396/05/18
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Ethics committee reference number
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Ir.mums.fm.rec.1396.254
Health conditions studied
1
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Description of health condition studied
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Dry eye syndrome
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ICD-10 code
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H04.1
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ICD-10 code description
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Dry eye syndrome
Primary outcomes
1
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Description
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Schirmer test
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Timepoint
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Measurment of schirmer test at baseline and 8 weeks after the intervention
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Method of measurement
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With schirmer paper
2
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Description
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Tear breakup time test
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Timepoint
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Measurment of Tear breakup time test at baseline and 8 weeks after the intervention
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Method of measurement
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With fluorescein paper and slit lamp and no anesthetics
3
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Description
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Tear osmolarity
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Timepoint
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Measurment of tear osmolarity at baseline and 8 weeks after the intervention
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Method of measurement
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With Tearlab osmolarity system
4
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Description
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Serum level of vitamin D
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Timepoint
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Measurment of serum level of vitamin D at baseline and 8 weeks after the intervention
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Method of measurement
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Vitamin D blood test
Intervention groups
1
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Description
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Intervention group: treatment of vitamin D deficiency with pearl 50000 u vitamin D per week until 8 weeks
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Category
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Treatment - Drugs
2
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Description
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Control group: routine treatment of dry eye with artificial tear drop
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Mashhad University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Any detail going to published
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When the data will become available and for how long
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6 months after validity
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To whom data/document is available
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Any scientific and collegiate institutions
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Under which criteria data/document could be used
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Any analusis allowed
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From where data/document is obtainable
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Arjmandae941@mums.ac.ir
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What processes are involved for a request to access data/document
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About 1 month after request with email
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Comments
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