Covid-19 & Vitamin D in Nursing-home

Status Completed

Clinical Trial Summary

First epidemiological data about COVID-19 pandemic confirm that older adults are likely to experience severe and lethal forms of SARS-CoV-2 infection, in particular frail elderly living in nursing-homes. Vitamin D could be a biological determinant of COVID-19, as indicated by genomic-guided tracing of SARS-CoV-2 targets in human cells. Epidemiological observational data are necessary for better understanding the links between vitamin D supplementation and COVID-19 outcomes, in particular in nursing-homes (in which the risk of hypovitaminosis D is very high).

The investigators had the opportunity to use information collected in a French middle-sized nursing-home affected by COVID-19 in March-April 2020, to determine whether recent vitamin D3 supplementation was associated with the prognosis of COVID-19 in residents infected with SARS-CoV-2. As recommended in French nursing-homes, all residents are systematically and regularly supplemented with bolus vitamin D3 (every single, 2 or 3 months, depending on residents).

The main objective of this study is to determine whether bolus vitamin D3 supplementation taken during or in the month before COVID-19 was effective in improving survival among frail elderly nursing-home residents infected with COVID-19 compared to those having received supplementation longer ago.

The secondary objective is to determine whether bolus vitamin D3 supplementation taken during or in the month before COVID-19 was effective in limiting the clinical severity of the infection according to the World Health Organization's Ordinal Scale for Clinical Improvement (OSCI) for COVID-19 compared to those having received supplementation longer ago.

Clinical Trial Description

Retrospective observational unicentric study in nursing-home residents with COVID-19. Health status monitoring data available until May 15, 2020. For all participants, gender, age, disability, history and comorbidities, treatments, date of last vitamin D3 supplementation, results of last blood test, date of suspicion / diagnosis of COVID-19, COVID-19 OSCI score, and eventual hospitalization or death (surveillance data available until May 15, 2020) are collected. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04435119
Study type	Observational
Source	University Hospital, Angers
Contact
Status	Completed
Phase
Start date	March 15, 2020
Completion date	May 15, 2020

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05065827` - Lung Ultrasound Findings in Patients With COVID-19 in a UK ED
Recruiting	`NCT05359770` - Association of Inspiratory Muscle Training With HD-tDCS for Assistance to Patients With Long Covid-19	N/A
Completed	`NCT04515147` - A Dose-Confirmation Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Vaccine CVnCoV in Healthy Adults for COVID-19	Phase 2
Not yet recruiting	`NCT06025812` - Clinical Study of Omicron BA.4/5-Delta Strain Recombinant Novel Coronavirus Protein Vaccine (CHO Cells)	N/A
Recruiting	`NCT05289115` - Protocol for Assistance to Patients With Long Covid-19 Undergoing Treatment With HD-tDCS	N/A
Completed	`NCT04953078` - A Study to Evaluate Safety, Tolerability, and Reactogenicity of an RBD-Fc-based Vaccine to Prevent COVID-19	Phase 1
Completed	`NCT04779138` - Increasing Vaccine Uptake in Underresourced Public Housing Areas	N/A
Not yet recruiting	`NCT05868239` - Impact of Aerosol Box Use During Cardiopulmonary Arrest: A Multicenter Study	N/A
Completed	`NCT04818164` - Prone Position Improves End-Expiratory Lung Volumes in COVID-19 Acute Respiratory Distress Syndrome
Completed	`NCT04690413` - NOWDx Test for the Detection of Antibodies to COVID-19	N/A
Terminated	`NCT04530448` - Coronavirus Induced Acute Kidney Injury: Prevention Using Urine Alkalinization	Phase 4
Completed	`NCT04572399` - UVA Light Device to Treat COVID-19	N/A
Recruiting	`NCT04610567` - Treatment of Patients With Mild Coronavirus-19 (COVID-19) Disease With Methotrexate Associated to LDL Like Nanoparticles (Nano-COVID19)	Phase 1/Phase 2
Recruiting	`NCT04772170` - Observational Digital Biomarker Discovery in Respiratory Virus Challenge Studies
Recruiting	`NCT04581954` - Inflammatory Signal Inhibitors for COVID-19 (MATIS)	Phase 1/Phase 2
Completed	`NCT04405934` - COG-UK Project Hospital-Onset COVID-19 Infections Study	N/A
Enrolling by invitation	`NCT04484025` - SPI-1005 Treatment in Moderate COVID-19 Patients	Phase 2
Completed	`NCT05572840` - Wear Your Mask, Wash Your Hands, Don't Get COVID-19	N/A
Withdrawn	`NCT04838847` - A Study to Evaluate the Immunogenicity and Safety of the SARS-CoV-2 mRNA Vaccine CVnCoV in Elderly Adults Compared to Younger Adults for COVID-19	Phase 3
Terminated	`NCT04371978` - Efficacy and Safety of Dipeptidyl Peptidase-4 Inhibitors in Diabetic Patients With Established COVID-19	Phase 3

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Covid-19 and Vitamin D in Nursing-home — COVIT-EHPAD

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms