Clinical trial NCT05425914: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye Syndromes
Hypovitaminosis D
Keywords: Artificial tears.
Dry eye syndrome.
vitamin d deficiency.
Lead sponsor: University of Faisalabad
Sponsor class: OTHER
First posted: 2022-06-21
Enrollment: 108
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Tear Breakup time in seconds
timeFrame: 90 days
measure: Schirmer test score in millimeters
timeFrame: 90 days
Secondary outcomes:
measure: Ocular surface disease index score in units
timeFrame: 90 days
measure: Numerical Pain Rating Scale
timeFrame: 90 days
Other outcomes:
Locations:
city: Chakwal
country: Pakistan
facility: RHC Buchal Kalan
state: Punjab
Study officials:
affiliation: The University of Faisalabad
name: Bushra Kanwal, MPO
role: PRINCIPAL_INVESTIGATOR
References: