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Completed

NCT Number: NCT05425914

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

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.

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Key information

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

RHC Buchal Kalan

Chakwal, Punjab Province, 48800, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vitamin D

Drug

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

Artificial tear

Drug

Conventional dry eye treatment

Primary outcomes

  1. Tear Breakup time in seconds

    Time frame: 90 days

    Improvement after vitamin D3 supplementation over a period of time

  2. Schirmer test score in millimeters

    Time frame: 90 days

    Improvement after vitamin D3 supplementation over a period of time

Secondary outcomes

  1. Ocular surface disease index score in units

    Time frame: 90 days

    Change in both groups after treatment. Values ranges from 0 to 100. Higher score indicates worse condition.

  2. Numerical Pain Rating Scale

    Time frame: 90 days

    Change in both groups after treatment. Values ranges from 0 to 10 wher 0 indicates no pain while 10 indicates worst pain

Sponsors and collaborators

Lead sponsor

University of Faisalabad

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 21, 2022
Registry last updated
Jun 21, 2022

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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