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Covid-19 and Vitamin D in Nursing-home

COvid-19 et VITamine d en EHPAD

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04435119
Acronym
COVIT-EHPAD
Enrollment
96
Registered
2020-06-17
Start date
2020-03-15
Completion date
2020-05-15
Last updated
2020-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronavirus

Brief 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.

Detailed 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.

Interventions

None listed

Sponsors

University Hospital, Angers
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Living in the nursing-home of Saint Laurent-de-Chamousset, France, during the COVID-19 epidemic (March-April 2020) * Being suspected or diagnosed with COVID-19 (RT-PCR, chest CT scan)

Exclusion criteria

\- Opposition of the resident and/or relatives to the use of anonymized clinical-biological data

Design outcomes

Primary

MeasureTime frame
Number of deaths of any cause in nursing-home residents with SARS-CoV-2 infection, depending on the use of bolus vitamin D3 supplementation during or just before COVID-19From March 2020 to 15 May 2020

Secondary

MeasureTime frameDescription
Clinical severity score of COVID19 in nursing-home residents with SARS-CoV-2 infection, depending on the use of bolus vitamin D3 supplementation during or just before COVID-19From March 2020 to 15 May 2020Clinical severity score of COVID19 is assessed with Ordinal Scale for Clinical Improvement (OSCI). OSCI ranges from 0 to 8, higher score meaning poorer outcome.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026