CTRI/2024/01/061970已完成Unknown
Assessment of the impact of Vitamin D3 supplementation on sleep quality in adults with vitamin D deficiency
MS Ramaiah Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2024年2月1日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Improvement in sleep quality
研究概览
简要总结
- This study is designed as a randomised controlled trial where all the adults detected with vitamin D deficiency when screened for the indications based on standard guidelines or incidentally detected will be included and divided into 2 arms where one arm receives a weekly 60000 IU of oral Vitamin D3 for a total of 8 weeks and the other arm receives 6000 IU daily for a period of 8 weeks in addition to advice on adequate lifestyle modifications and dietary changes given for both the groups. Standard questionnaire will be used to record the baseline sleep quality indices (Pittsburg Sleep quality index). After 8 weeks, all the participants will be reassessed with the same standard questionnaire along with a repeat Vitamin D3 estimation. The sleep quality indices shall be compared between baseline and follow up to assess the efficient method of vitamin D3 supplementation in adults detected with Vitamin D deficiency.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Lab evidence of Vitamin D3 deficiency detected when screened as per guidelines for fibromyalgia or nonspecific musculoskeletal complaints and incidentally detected patients.
排除标准
- •Those on sedatives, granulomatous disorders, volume overload status clinically, pregnant, anaemic, alcohol intake in last 3 months and those who deny to consent.
结局指标
主要结局
Improvement in sleep quality
时间窗: 0,8 week
次要结局
- Correction of Vitamin D3 levels by effective method(0,8 week)
研究者
Dr Lakshmi Priya
MS Ramaiah Medical College
研究点 (1)
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