NCT05415254Unknown不适用
A Randomized Open Label Study to Evaluate Efficacy of Calcitriol Supplementation in COVID-19 Patients With Vitamin D Deficiency
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- The cycle threshold (Ct) value of COVID-19 nucleic acid after treatment
研究概览
简要总结
This is a randomized, open label study to evaluate the efficacy and safety of calcitriol supplementation in COVID-19 patients with vitamin D deficiency.
详细描述
This is a randomized, open label study to evaluate the efficacy （clinical and laboratory change）and safety （serum calcium） of calcitriol supplementation in COVID-19 patients with vitamin D deficiency.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalized symptomatic COVID-19 patients;
- •COVID-19 nucleic acid Ct value < 28 (both orf1ab gene Ct value and N gene Ct value < 28);
- •Vitamin D deficiency: 25OHD ≤ 20ng/ml;
- •Age: 18-70 years old;
排除标准
- •Asymptomatic COVID-19 patients ；
- •Hypercalcemia;
- •History of primary hyperparathyroidism;
- •History of triple hyperparathyroidism;
- •Patients who are allergic to calcitriol;
- •Pregnant or lactating women;
- •Patients with severe heart or lung diseases or tumor history;
- •Patients already taking vitamin D or its similar preparations;
- •Participants in other interventional clinical studies (including taking paxlovid);
- •Patients with renal insufficiency (eGFR<60ml/min/1.73m2);
- •Patients considered unsuitable for this study by the investigator；
研究组 & 干预措施
treatment group
Experimental
calcitriol 0.25ug daily for 10 days + COVID-19 routine treatment
干预措施: Calcitriol (Drug)
结局指标
主要结局
The cycle threshold (Ct) value of COVID-19 nucleic acid after treatment
时间窗: The 6th day after treatment
Nucleic acid test of COVID-19
次要结局
- Clinical symptoms changes(The 6th day after treatment)
- Laboratory examination changes(The 6th day after treatment)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Clinical Effectiveness of DermACELL AWM in Subjects With Chronic Venous Leg UlcersVenous Leg UlcerNCT03589586LifeNet Health100
已完成
不适用
A Clinical Study to Assess the Effect of Increasing Intake Amounts of Two Novel Glycans on the Gut Microbiota of Healthy SubjectsHealthyNCT04619875Kaleido Biosciences36
已完成
3 期
Neoadjuvant Chemo-endocrine Therapy Versus Chemotherapy Alone in ER-positive, HER2-negative Breast CancerBreast Cancer FemaleNCT02980965Fudan University249
Unknown
3 期
Philippine Trial to Determine Efficacy and Safety of Favipiravir for COVID-19Covid19NCT05014373University of the Philippines144
Unknown
2 期
All-trans Retinoic Acid (ATRA) in the Treatment of Recurrent/Metastatic Adenoid Cystic Carcinoma of the Head and NeckAdenoid Cystic Carcinoma of the Head and NeckNCT04433169Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University30