Impact of Vitamin D3 Supplementation in Non-Sjogren Dry Eye Patients With Low Serum Vitamin D Level

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye Syndromes; Hypovitaminosis D
• Intervention / Treatment: Drug: Artificial tear; Drug: Vitamin D

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Phase 3

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Chakwal, Punjab, Pakistan, 48800
      • RHC Buchal Kalan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional Treatment; Receiving conventional dry eye treatment in the form of artificial tears four times per days for 90 days.	Drug: Artificial tear; Conventional dry eye treatment
Experimental: Vitamin D3 Supplementation; Receiving vitamin d3 supplementation 6000IU per day along with artificial tears for 90 days.	Drug: Artificial tear; Conventional dry eye treatment; Drug: Vitamin D; New treatment option for dry eye patients with low serum vitamin D Level

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tear Breakup time in seconds	Improvement after vitamin D3 supplementation over a period of time	90 days
Schirmer test score in millimeters	Improvement after vitamin D3 supplementation over a period of time	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ocular surface disease index score in units	Change in both groups after treatment. Values ranges from 0 to 100. Higher score indicates worse condition.	90 days
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	90 days

Collaborators and Investigators

• Sponsor: University of Faisalabad
• Investigators: Principal Investigator: Bushra Kanwal, MPO, The University of Faisalabad

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Actual): March 15, 2022
• Study Completion (Actual): April 30, 2022

Study Registration Dates

• First Submitted: June 11, 2022
• First Submitted That Met QC Criteria: June 15, 2022
• First Posted (Actual): June 21, 2022

Study Record Updates

• Last Update Posted (Actual): June 21, 2022
• Last Update Submitted That Met QC Criteria: June 15, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Artificial tears.; Dry eye syndrome.; vitamin d deficiency.
• Additional Relevant MeSH Terms: Metabolic Diseases; Eye Diseases; Nutrition Disorders; Musculoskeletal Diseases; Deficiency Diseases; Malnutrition; Bone Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Bone Diseases, Metabolic; Calcium Metabolism Disorders; Vitamin D Deficiency; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Rickets; Avitaminosis; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Pharmaceutical Solutions; Ophthalmic Solutions; Vitamin D; Lubricant Eye Drops
• Other Study ID Numbers: TUF Faisalabad

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Plan to share results only due to confidentiality

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No