NCT04407286已完成1 期
Vitamin D Testing and Treatment for Adults With COVID 19
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- severity of COVID 19 symptoms
研究概览
简要总结
This study will measure vitamin D levels in adults with COVID 19. Participants with low levels of vitamin D will be entered into an open label trial of supplementation with vitamin D.
详细描述
Protocol for Part 1:
- A single blood draw at SCNM to measure levels of vitamin D and other nutrients, comprehensive metabolic panel, and complete blood count with differential
- Completing a medical history/symptom form
- Completing a form about COVID-19 symptoms every 2 weeks for 6 weeks
- Authorization for release of medical records related to COVID 19 testing and/or treatment.
Protocol for Part 2:
- Take a vitamin D supplement daily for two weeks, at a dosage of 10,000 IU/day b.i.d. (age 18-69 years) or 15,000 IU/day t.i.d. (age 70+)
- After two weeks of taking vitamin D, return to SCNM for a blood draw to remeasure levels of vitamin D, comprehensive metabolic panel, and complete blood count with differential. If vitamin D levels are still below 30 ng/ml, continue the dosage for 3 more weeks. If vitamin D levels are 30-49 ng/ml, continue at a dosage of 5000 IU/day. If vitamin D levels are 50+ ng/ml, stop supplementation.
- Completing questionnaires about COVID 19 symptoms at 2, 4, and 6 weeks after treatment begins (5 minutes each time).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
severity of COVID 19 symptoms
时间窗: baseline and at 2 weeks after vitamin D supplementation
We will calculate the change in severity of COVID 19 symptoms from baseline to 2 weeks after vitamin D supplementation
Vitamin D levels
时间窗: baseline and after two weeks of vitamin D supplementation
change in level of Vitamin D, 25-Hydroxy between the two time points
次要结局
未报告次要终点
研究者
研究点 (2)
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