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

• Sponsor: University of Faisalabad (Other)
• Overall Status: Completed
• CT.gov ID: NCT05425914
• Collaborator: (none)
• Enrollment: 108
• Location: 1
• Arms: 2
• Actual Duration (Months): 5.9
• Patients Per Site Per Month: 18.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Syndromes; Hypovitaminosis D	Drug: Vitamin D; Drug: Artificial tear	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 108 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Impact of Vitamin D3 Supplementation in Non-Sjogren Dry Eye Patients With Low Serum Vitamin D Level
• Actual Study Start Date: Nov 1, 2021
• Actual Primary Completion Date: Mar 15, 2022
• Actual Study Completion Date: Apr 30, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Tear Breakup time in seconds [90 days]

   Improvement after vitamin D3 supplementation over a period of time

2. Schirmer test score in millimeters [90 days]

   Improvement after vitamin D3 supplementation over a period of time

Secondary Outcome Measures

1. 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.

2. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	RHC Buchal Kalan	Chakwal	Punjab	Pakistan	48800

Sponsors and Collaborators

• University of Faisalabad

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bushra Kanwal, Principal Investigator, University of Faisalabad
• ClinicalTrials.gov Identifier: NCT05425914
• Other Study ID Numbers: TUF Faisalabad
• First Posted: Jun 21, 2022
• Last Update Posted: Jun 21, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Bushra Kanwal, Principal Investigator, University of Faisalabad: Artificial tears.; Dry eye syndrome.; vitamin d deficiency.
• Additional relevant MeSH terms: Rickets; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Avitaminosis; Vitamin D Deficiency; Vitamin D; Lubricant Eye Drops

Study Results

No Results Posted as of Jun 21, 2022