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

Dry Eye Syndromes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05425914
• Other study ID #: TUF Faisalabad
• Status: Completed
• Phase: Phase 3
• Start date: November 1, 2021
• Est. completion date: April 30, 2022

Study information

• Verified date: June 2022
• Source: University of Faisalabad
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: April 30, 2022
• Est. primary completion date: March 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Avitaminosis
• Dry Eye Syndromes
• Hypovitaminosis D
• Keratoconjunctivitis Sicca
• Rickets
• Vitamin D Deficiency

Intervention

Drug:
• Vitamin D
New treatment option for dry eye patients with low serum vitamin D Level
• Artificial tear
Conventional dry eye treatment

Locations

Country	Name	City	State
Pakistan	RHC Buchal Kalan	Chakwal	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
University of Faisalabad

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tear Breakup time in seconds	Improvement after vitamin D3 supplementation over a period of time	90 days
Primary	Schirmer test score in millimeters	Improvement after vitamin D3 supplementation over a period of time	90 days
Secondary	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
Secondary	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