Clinical trial NCT05214040: Vitamin D Insufficiency inVestigation Among hospitaLizeD Inpatients
Official title: Vitamin D Insufficiency inVestigation Among hospitaLizeD Inpatients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hypovitaminosis D
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2022-01-28
Enrollment: 300000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All consecutive patients meeting the eligibility criteria over the study period.

Brief summary: Hypovitaminosis D is common in the adult population, it affects at least 1 billion people worldwide, and in particular 80% of the French population according to the National Institute for Public Health Surveillance. Hypovitaminosis D is accompanied or complicated by deleterious health manifestations such as bone, immune and cancer diseases, neuromuscular disorders and a propensity to fall, for example. Hypovitaminosis D has also been associated with more complicated care pathways (increase in the severity of the reason for hospitalization, length of hospitalization, risk of in-hospital death). Prevention of these clinical events depends on correcting vitamin D status.

In sick, dependent or fragile adults, natural intakes are generally insufficient. It is indeed accepted that hypovitaminosis D may not be treated effectively by dietary measures or by simple exposure to the sun in French latitudes. Drug supplementation is therefore necessary, with the objective of achieving a target concentration of circulating 25-hydroxyvitamin D (25 (OH) D) of 75 nmol / L (30 ng / mL) in this population.

Vitamin D supplementation, when properly conducted, corrects hypovitaminosis D, and has been associated with improved prognosis, especially life-saving, in therapeutic trials versus placebo. Such results lead the investigators to suggest that the identification and correction of hypovitaminosis D in hospitalized patients could represent a simple, effective and inexpensive strategy for improving hospital care pathways. In this perspective, the first step is to determine the prevalence, severity and clinical profile of hospitalized patients with hypovitaminosis D, as well as their course of care. To the investigators knowledge, there are no large-scale studies based on real-life data on this subject.


Eligibility criteria: Inclusion Criteria:

* ≥ 18 years old
* have had a dosage of circulating 25-hydroxyvitamin D (plasma or serum) in a HUGO establishment
* consultant or hospitalized between 01/01/2015 and 12/31/2019 in one of the participating HUGOs.

Exclusion Criteria:

* None

Primary outcomes:
measure: Prevalence and depth of hypovitaminosis D
timeFrame: baseline
Secondary outcomes:
measure: Clinical profile
timeFrame: baseline
measure: Length of hospitalisation
timeFrame: baseline
measure: Mortality
timeFrame: baseline, 14 and 28 days, 3 and 6 months after the dosage
Other outcomes:
Locations:
Study officials:
affiliation: Angers University Hospital
name: Cédric ANNWEILER, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: