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临床试验/NCT05425914
NCT05425914已完成3 期

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

University of Faisalabad1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2021年11月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
108
试验地点
1
主要终点
Tear Breakup time in seconds

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Conventional Treatment

Active Comparator

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

干预措施: Artificial tear (Drug)

Vitamin D3 Supplementation

Experimental

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

干预措施: Vitamin D (Drug)

Vitamin D3 Supplementation

Experimental

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

干预措施: Artificial tear (Drug)

结局指标

主要结局

Tear Breakup time in seconds

时间窗: 90 days

Improvement after vitamin D3 supplementation over a period of time

Schirmer test score in millimeters

时间窗: 90 days

Improvement after vitamin D3 supplementation over a period of time

次要结局

  • Ocular surface disease index score in units(90 days)
  • Numerical Pain Rating Scale(90 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bushra Kanwal

Principal Investigator

University of Faisalabad

研究点 (1)

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