BridgeMD
Vitamin D as add-on treatment option of pneumonia and sepsis in elderly subjects (TreatViD)
EU CTIS ID: 2024-515978-27-00
What this study is testing
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)).
- Phase III and phase IV (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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;
- NEWS2>2;
You likely can't join if
- 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.
See the full eligibility criteria
- 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;
- NEWS2>2;
- Patient or his/her legal representative ability to understand, sign, and date the written authorized informed consent form.
- 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;
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.