跳至主要内容
临床试验/CTRI/2020/01/023087
CTRI/2020/01/023087尚未招募2/3 期

A prospective, randomized controlled clinical trial to assess the efficacy of directly observed vitamin D supplementation among vitamin D deficient anesthesia workers

fluid research fund1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2020年1月2日最近更新:
适应症

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
54
试验地点
1
主要终点
comparing the difference in the improvement of serum vitamin D level at the end of eight months of supplementation of 25(OH)d to both groups

研究概览

简要总结

This is an interventional study among the healthcare workers in the department of anaesthesia ,CMCH, Vellore, who are found to have deficiency in serum vitamin D levels. The staff workers who are found to have vitamin D levels below the recommended normal values are recruited for the study. A semi-structured questionnaire will be administered to assess the symptoms of vitamin D deficiency, type of work they are involved in, duration of sun exposure, compliance to vitamin D supplementations. The study  population is then randomized to two groups observed and unobserved. Participants in the observed group are supplemented under direct observation while the subjects in the unobserved group are asked to take on their own as per the prescribed schedule and to bring back the empty sachets at the end of study. The difference in increase of serum vitamin D levels in both groups are tested, along with assess the improvement in symptoms, compliance  and quality of life

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • •healthy volunteers with 25(OH)D levels < 30 ng/ml.

排除标准

  • •age less than 18 years subjects with chronic illness and other endocrine disorders subjects who are on vitamin D supplementation.

结局指标

主要结局

comparing the difference in the improvement of serum vitamin D level at the end of eight months of supplementation of 25(OH)d to both groups

时间窗: comparing the difference in the improvement of serum vitamin D level at the end of eight months of supplementation of 25(OH)d to both groups

次要结局

  • improvement in symptoms of vitamin D(improvement in health related quality of life)

研究者

发起方
fluid research fund
申办方类型
Research institution

研究点 (1)

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