Impact of Vitamin D3 Supplementation in Non-Sjogren Dry Eye Patients With Low Serum Vitamin D Level
Primary Purpose
Dry Eye Syndromes, Hypovitaminosis D
Status
Completed
Phase
Phase 3
Locations
Pakistan
Study Type
Interventional
Intervention
Vitamin D
Artificial tear
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye Syndromes focused on measuring Artificial tears., Dry eye syndrome., vitamin d deficiency.
Eligibility Criteria
Inclusion Criteria:
- Patients with non-Sjogren dry eyes with low serum vitamin D level.
- Both gender.
- Age group will be 20-50 years of age.
- Cooperative patients.
Exclusion Criteria:
- Autoimmune diseases (such as Sjogren syndrome and lupus syndrome).
- All ocular pathologies except dry eyes.
- All systemic pathologies that affects tear layers.
- All non- cooperative patients.
Sites / Locations
- RHC Buchal Kalan
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Conventional Treatment
Vitamin D3 Supplementation
Arm Description
Receiving conventional dry eye treatment in the form of artificial tears four times per days for 90 days.
Receiving vitamin d3 supplementation 6000IU per day along with artificial tears for 90 days.
Outcomes
Primary Outcome Measures
Tear Breakup time in seconds
Improvement after vitamin D3 supplementation over a period of time
Schirmer test score in millimeters
Improvement after vitamin D3 supplementation over a period of time
Secondary Outcome Measures
Ocular surface disease index score in units
Change in both groups after treatment. Values ranges from 0 to 100. Higher score indicates worse condition.
Numerical Pain Rating Scale
Change in both groups after treatment. Values ranges from 0 to 10 wher 0 indicates no pain while 10 indicates worst pain
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05425914
Brief Title
Impact of Vitamin D3 Supplementation in Non-Sjogren Dry Eye Patients With Low Serum Vitamin D Level
Official Title
Impact of Vitamin D3 Supplementation in Non-Sjogren Dry Eye Patients With Low Serum Vitamin D Level
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
March 15, 2022 (Actual)
Study Completion Date
April 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Faisalabad
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Dry eye disease is multifactorial, ocular inflammatory condition causing irritation, stinging sensation, uneasiness and blurring. Non-Sjogren syndrome occurs due to absent or dysfunction of lacrimal gland. Fat soluble vitamin D act as an agent against inflammation and its deficiency may result in various inflammatory diseases including dry eye. Purpose of this study is evaluation of vitamin D3 supplementation role in treating non-Sjogren dry eye along with conventional treatment by using artificial tears in patients with hypovitaminosis D. A prospective study was conducted in Rural health center(RHC) Buchal Kalan on 108 patients presenting with non-Sjogren dry eyes and low serum vitamin D levels. Patients were subjected to the following examination; best corrected visual acuity (BCVA), slit-lamp examination, applanation tonometry, fundoscopy, tear breakup time (TBUT) after fluorescein staining, Schirmer tear test, numerical pain rating scale (NPRS) and ocular surface disease index (OSDI) score on day 0, 15, 30, 60 and 90. Vitamin D levels was assessed by electrochemiluminescence immunoassay (ECLIA) based analyzer. The sample was randomly divided into two groups by non-probability purposive sampling. Group 1 received only artificial tears 4times/day while group 2 were given oral vitamin D3 supplementation of 6000 international unit (IU) daily along with artificial tears. Impact of oral vitamin D3 supplementation on non-Sjogren dry eyes was assessed by comparing means of ocular parameters of both groups over different period of time by using Mann-Whitney Test and Friedman Test.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes, Hypovitaminosis D
Keywords
Artificial tears., Dry eye syndrome., vitamin d deficiency.
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
108 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional Treatment
Arm Type
Active Comparator
Arm Description
Receiving conventional dry eye treatment in the form of artificial tears four times per days for 90 days.
Arm Title
Vitamin D3 Supplementation
Arm Type
Experimental
Arm Description
Receiving vitamin d3 supplementation 6000IU per day along with artificial tears for 90 days.
Intervention Type
Drug
Intervention Name(s)
Vitamin D
Intervention Description
New treatment option for dry eye patients with low serum vitamin D Level
Intervention Type
Drug
Intervention Name(s)
Artificial tear
Intervention Description
Conventional dry eye treatment
Primary Outcome Measure Information:
Title
Tear Breakup time in seconds
Description
Improvement after vitamin D3 supplementation over a period of time
Time Frame
90 days
Title
Schirmer test score in millimeters
Description
Improvement after vitamin D3 supplementation over a period of time
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Ocular surface disease index score in units
Description
Change in both groups after treatment. Values ranges from 0 to 100. Higher score indicates worse condition.
Time Frame
90 days
Title
Numerical Pain Rating Scale
Description
Change in both groups after treatment. Values ranges from 0 to 10 wher 0 indicates no pain while 10 indicates worst pain
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with non-Sjogren dry eyes with low serum vitamin D level.
Both gender.
Age group will be 20-50 years of age.
Cooperative patients.
Exclusion Criteria:
Autoimmune diseases (such as Sjogren syndrome and lupus syndrome).
All ocular pathologies except dry eyes.
All systemic pathologies that affects tear layers.
All non- cooperative patients.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bushra Kanwal, MPO
Organizational Affiliation
The University of Faisalabad
Official's Role
Principal Investigator
Facility Information:
Facility Name
RHC Buchal Kalan
City
Chakwal
State/Province
Punjab
ZIP/Postal Code
48800
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Plan to share results only due to confidentiality
Learn more about this trial
Impact of Vitamin D3 Supplementation in Non-Sjogren Dry Eye Patients With Low Serum Vitamin D Level
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