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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05425914
Enrollment
108
Registered
2022-06-21
Start date
2021-11-01
Completion date
2022-04-30
Last updated
2022-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye Syndromes, Hypovitaminosis D

Keywords

Artificial tears., Dry eye syndrome., vitamin d deficiency.

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.

Interventions

DRUGVitamin D

New treatment option for dry eye patients with low serum vitamin D Level

Conventional dry eye treatment

Sponsors

University of Faisalabad
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Tear Breakup time in seconds90 daysImprovement after vitamin D3 supplementation over a period of time
Schirmer test score in millimeters90 daysImprovement after vitamin D3 supplementation over a period of time

Secondary

MeasureTime frameDescription
Ocular surface disease index score in units90 daysChange in both groups after treatment. Values ranges from 0 to 100. Higher score indicates worse condition.
Numerical Pain Rating Scale90 daysChange in both groups after treatment. Values ranges from 0 to 10 wher 0 indicates no pain while 10 indicates worst pain

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026