Vitamin D Supplementation and Covid-19: a Randomised, Double- Blind, Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Vitamin D serum concentration
研究概览
简要总结
The objective of the study is to evaluate the clinical efficacy and safety of vitamin D supplementation in hospitalized patients with COVID-19.
详细描述
Phase IV, interventional, randomised, double blind, placebo-controlled and parallel study to evaluate the clinical efficacy and safety of vitamin D supplementation in hospitalized patients with COVID-19.
Patients will participate in the study for a maximum of 9 weeks, which includes an up to 6-week treatment period and a maximum of 3-week follow-up period.
A total of 100 (50 in each group) patients will be randomized in the study and will either receive the test treatment or the placebo treatment.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Male and female over 18 years old (18 years inclusive).
- •Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen as diagnosed within 72 hours prior to randomization.
- •Expected to survive for at least 96 hours after study entry.
- •If patient is a female of childbearing potential, patient must use an effective means of birth control (oral, intravaginal or transdermal oestrogen-progestogen combined hormonal contraceptives or intrauterine devices or sexual abstinence).
- •Subject or legally authorized representative understands and agrees to comply with planned study procedures.
- •Subject or legally authorized representative provides informed consent prior to initiation of any study procedures.
排除标准
- •Women currently pregnant or breast-feeding.
- •Patients presenting acute impairment of renal function or nephrolithiasis.
- •Patients presenting hypercalcaemia and/or hypercalciuria
- •Patients presenting pseudohypoparathyroidism
- •Use of any vitamin D supplementation alone or in association at screening visit;
- •Use of any prohibited medication as detailed in the concomitant medication section
- •Patients with any sensitivity or allergy to any of the products used within this clinical trial.
- •Presence of any other condition or illness, which, in the opinion of the investigator, would interfere with optimal participation in the study.
研究组 & 干预措施
Test treatment
Test Treatment: Ampoule for enteral use containing 25,000 IU/mL of cholecalciferol taken according to the following scheme: one ampoule on Day 1, Day 2, Day 3, Day 4, Day 8, Day 15, Day 22, Day 29 and Day 36.
干预措施: Cholecalciferol (Drug)
Placebo treatment
Placebo Treatment: Ampoule of placebo for enteral use containing excipient only taken according to the following scheme: one ampoule on Day 1, Day 2, Day 3, Day 4, Day 8, Day 15, Day 22, Day 29 and Day 36.
干预措施: Placebo (Other)
结局指标
主要结局
Vitamin D serum concentration
时间窗: Baseline, on days 8, 15, 22, 29 (+/-1 day), or last day of hospitalization, and finally at day 15 to 30 after hospital discharge
Mean change from screening to end of treatment phase in 25(OH)D3 serum concentration
次要结局
- Intensive care unit length of stay.(at day 15 to 30 after hospital discharge)
- Clinical improvement(Baseline and up to 4 weeks after randomization on days 8, 15, 22, 29 (+/-1 day), or last day of hospitalization, and finally at day 15 to 30 after hospital discharge)
- Hospital length of stay.(at day 15 to 30 after hospital discharge)
- Supplemental oxygen, non-invasive or invasive ventilation or organ support(Baseline and up to 4 weeks after randomization on days 8, 15, 22, 29 (+/-1 day), or last day of hospitalization, and finally at day 15 to 30 after hospital discharge)
- Duration of supplemental oxygen, non-invasive or invasive ventilation or organ support(at day 15 to 30 after hospital discharge)
- Absence of fever(Last day of hospitalization, or at at day 15 to 30 after hospital discharge)
- Time until negative laboratory SARS-CoV-2 test.(Last day of hospitalization , or at at day 15 to 30 after hospital discharge)
- Mortality all causes.(Last day of hospitalization , or at at day 15 to 30 after hospital discharge)
- Mortality related to Covid-19.(Last day of hospitalization , or at at day 15 to 30 after hospital discharge)
- Biological markers(Baseline, on days 8, 15, 22, 29 (+/-1 day), or last day of hospitalization, and finally at day 15 to 30 after hospital discharge)
研究者
Anne-Françoise Rousseau
Head of Clinic
University of Liege