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