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

Phase 3

Completed

• Conditions: Hypovitaminosis D; Dry Eye Syndromes
• Interventions: Drug: Artificial tear; Drug: Vitamin D

• Registration Number: NCT05425914
• Lead Sponsor: University of Faisalabad

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-01
• Primary Completion: 2022-03-15
• Study Completion: 2022-04-30
• Status Verified: 2022-06
• Study First Submitted: 2022-06-11
• Study First Submitted QC: 2022-06-15
• Last Update Submitted: 2022-06-15
• Study First Posted: 2022-06-21
• Last Update Posted: 2022-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Treatment	Artificial tear	Receiving conventional dry eye treatment in the form of artificial tears four times per days for 90 days.
Vitamin D3 Supplementation	Artificial tear	Receiving vitamin d3 supplementation 6000IU per day along with artificial tears for 90 days.
Vitamin D3 Supplementation	Vitamin D	Receiving vitamin d3 supplementation 6000IU per day along with artificial tears for 90 days.

Primary Outcome Measures

Name	Time	Method
Tear Breakup time in seconds	90 days	Improvement after vitamin D3 supplementation over a period of time
Schirmer test score in millimeters	90 days	Improvement after vitamin D3 supplementation over a period of time

Secondary Outcome Measures

Name	Time	Method
Ocular surface disease index score in units	90 days	Change in both groups after treatment. Values ranges from 0 to 100. Higher score indicates worse condition.
Numerical Pain Rating Scale	90 days	Change in both groups after treatment. Values ranges from 0 to 10 wher 0 indicates no pain while 10 indicates worst pain

Trial Locations

Locations (1)

RHC Buchal Kalan; 🇵🇰 Chakwal, Punjab, Pakistan