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

NCT05425914 | Completed Phase 3

• 1 other identifier: TUF Faisalabad
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye Syndromes; Hypovitaminosis D

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Tear Breakup time in seconds

  Improvement after vitamin D3 supplementation over a period of time

  90 days

• Schirmer test score in millimeters

  Improvement after vitamin D3 supplementation over a period of time

  90 days

Secondary Outcomes (2)

• Ocular surface disease index score in units

  90 days

• Numerical Pain Rating Scale

  90 days

Study Arms (2)

Conventional Treatment

ACTIVE COMPARATOR

Receiving conventional dry eye treatment in the form of artificial tears four times per days for 90 days.

Drug: Artificial tear

Vitamin D3 Supplementation

EXPERIMENTAL

Receiving vitamin d3 supplementation 6000IU per day along with artificial tears for 90 days.

Drug: Vitamin D; Drug: Artificial tear

Interventions

Vitamin D DRUG

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

Vitamin D3 Supplementation

Artificial tear DRUG

Conventional dry eye treatment

Conventional Treatment; Vitamin D3 Supplementation

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Faisalabad: lead

Study Sites (1)

RHC Buchal Kalan

Chakwal, Punjab Province, 48800, Pakistan

Location

MeSH Terms

Conditions

Dry Eye Syndromes; Vitamin D Deficiency

Interventions

Vitamin D; Lubricant Eye Drops

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Ophthalmic Solutions; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Lubricants; Specialty Uses of Chemicals

Study Officials

• Bushra Kanwal, MPO

  The University of Faisalabad

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 11, 2022
• First Posted: June 21, 2022
• Study Start: November 1, 2021
• Primary Completion: March 15, 2022
• Study Completion: April 30, 2022
• Last Updated: June 21, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)