Vitamin D as add-on treatment option of pneumonia and sepsis in elderly subjects (TreatViD)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 552
- 试验地点
- 2
- 主要终点
- 1) Evaluation of a high dose vitamin D3 regimen effectiveness with respect to placebo in modifying one of the following (whichever occurs first): • Difference in the proportion of patients reaching an in-hospital negative outcome (in-hospital death or ICU admission), within 10 days from admission; • Difference in the proportion of patients reaching an in-hospital positive outcome (discharge or clinical resolution of symptoms (stable NEWS2<2 for at least 24 hours) within 10 days from admission)
研究概览
简要总结
The aim/objective of TreatViD clinical trial is to evaluate efficacy and safety of a high dose vitamin D3 (cholecalciferol) regimen in elderly patients hospitalized for pneumonia due to an infection (including COVID-19), study section 1,or sepsis, study section 2, in increasing discharge rate from hospital and/or reducing in-hospital mortality and/or in reducing laboratory markers of inflammation. To reach such goal, the proposed clinical trial is divided in two separated sections according to the underlying diagnosis at admission (pneumonia section (1) and sepsis section (2)).
入排标准
- 年龄范围
- 65 years 至 65+ years（65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 65 years (no gender restriction);
- •Fulfillment of one of the two following diagnostic criteria: • Diagnosis of pneumonia due to a presumed infection, confirmed by chest plain radiographs or CT scan, according to the ATS/IDSA guidelines [Metlay et al., 2019; Mandell et al., 2007] (including COVID-19 related pneumonia confirmed by a RT-PCR or third-generation antigenic test) (pneumonia section of the study); • Diagnosis of sepsis (patients meeting the Third International Consensus Definitions for Sepsis; Sepsis-3 [Singer et al., 2016]) (sepsis section of the study);
- •Need for hospitalization in a non-intensive care unit (non-ICU) (hospitalization in general wards including high dependency/sub-intensive wards);
- •Serum 25(OH)D < 20 ng/ml at admission.
- •Symptoms onset from no more than 10 days;
- •Patient or his/her legal representative ability to understand, sign, and date the written authorized informed consent form.
排除标准
- •Extremely critical presentation, suggestive of immediate need for ICU admission of imminent death;
- •Severe renal failure (GFR < 15 ml/min) or history of recurrent nephrolithiasis;
- •Hypercalcemia (ionized serum calcium > 1.4 mmol/l (5.6 mg/dl) or albumin-adjusted serum calcium > 2.63 mmol/l (10.5 mg/dl));
- •History of chronic liver diseases associated to liver failure (i.e. hepatic cirrhosis CHILDB or greater);
- •Known malabsorption syndromes;
- •Participation in a clinical trial in which an investigational drug was administered within 30 days of screening or within 5 half-lives of the study drug, whichever is longer.
- •Known sarcoidosis;
- •Known primary hyperparathyroidism;
- •History of nephrocalcinosis;
- •History of hypercalciuria (urinary calcium excretion > 0.1 mmol/kg body weight/day (4 mg/kg body weight/day));
- •BMI > 35 kg/m2;
- •Inability to tolerate or clinical conditions contraindicating oral therapy or vitamin D supplementation.
- •Advanced cancer or other advanced chronic diseases with an estimated prognosis of less than 30 days;
- •Known history of allergy/intolerance to cholecalciferol (vitamin D3) or any excipient used in the intervention formulation;
结局指标
主要结局
1) Evaluation of a high dose vitamin D3 regimen effectiveness with respect to placebo in modifying one of the following (whichever occurs first): • Difference in the proportion of patients reaching an in-hospital negative outcome (in-hospital death or ICU admission), within 10 days from admission; • Difference in the proportion of patients reaching an in-hospital positive outcome (discharge or clinical resolution of symptoms (stable NEWS2<2 for at least 24 hours) within 10 days from admission)
1) Evaluation of a high dose vitamin D3 regimen effectiveness with respect to placebo in modifying one of the following (whichever occurs first): • Difference in the proportion of patients reaching an in-hospital negative outcome (in-hospital death or ICU admission), within 10 days from admission; • Difference in the proportion of patients reaching an in-hospital positive outcome (discharge or clinical resolution of symptoms (stable NEWS2<2 for at least 24 hours) within 10 days from admission)
2) Evaluation of a high dose vitamin D3 regimen effectiveness with respect to placebo in modifying one of the following: • Difference in the proportion of patient with a 50% reduction of circulating Il-6 within 10 days from admission; • Difference in the proportion of patient with a 50% reduction of circulating C-reactive protein (CRP) within 10 days from admission;
2) Evaluation of a high dose vitamin D3 regimen effectiveness with respect to placebo in modifying one of the following: • Difference in the proportion of patient with a 50% reduction of circulating Il-6 within 10 days from admission; • Difference in the proportion of patient with a 50% reduction of circulating C-reactive protein (CRP) within 10 days from admission;
次要结局
- Difference in the proportion of patients reaching an in-hospital negative or positive outcome (as previously defined) among patient stratified by age (65-80 years old and ≥80 years old);
- Difference in oxygen supplementation and/or mechanical non-invasive ventilation need and its duration (only for patients of the pneumonia section of the study);
- Difference in mortality rate at 10, 14, 28 and 90 days;
- Difference in hospitalization length (expressed in days);
- Difference in plasma vitamin D levels at 2-5-7-10 days (vitamin D quantification data will be extracted from both study-specific blood draws (at 7 and 10 days) and from blood draws performed in order to monitor intervention safety (at 2 and 5 days));
- Difference in the proportion of CRP levels reduction below 1 mg/ml at 7 and 10 days;
- Difference in inflammatory biomarkers panel (see protocol) at 2-5-7-10 days;
- Difference in the proportion of patients reaching an in-hospital negative or positive outcome (as previously defined) among patient stratified by Vitamin D plasma levels at 10 days from admisison (<20 ng/ml and ≥20 ng/ml);
- Difference in adverse events and proportion of severe adverse events
研究者
Pier Paolo Sainaghi
Scientific
Azienda Ospedaliero-Universitaria Maggiore Della Carita