Vitamin D Insufficiency inVestigation Among hospitaLizeD Inpatients (VIVALDI)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypovitaminosis D

• Study Type: Observational
• Enrollment (Anticipated): 300000

Contacts and Locations

• Study Contact: Name: Cédric ANNWEILER, MD,PhD; Phone Number: +33 02 41 35 47 25; Email: cedric.annweiler@chu-angers.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All consecutive patients meeting the eligibility criteria over the study period.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence and depth of hypovitaminosis D	the prevalence of hypovitaminosis D will be calculated for each of the 3 definition thresholds for hypovitaminosis D found in the literature: ≤ 75 nmol/L, ≤ 50 nmol/L and ≤ 25 nmol/L.	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical profile	The clinical profile will be determine by the data provided by the physician during the hospitalization or the consultation	baseline
Length of hospitalisation	determine whether the circulating 25-hydroxyvitamin D concentration is associated with the length of hospitalization in days	baseline
Mortality	determine whether the circulating 25-hydroxyvitamin D concentration is associated with the death occurring during hospital stay.	baseline, 14 and 28 days, 3 and 6 months after the dosage

Collaborators and Investigators

• Sponsor: University Hospital, Angers
• Investigators: Principal Investigator: Cédric ANNWEILER, MD,PhD, Angers University Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): September 1, 2026
• Study Completion (Anticipated): September 1, 2026

Study Registration Dates

• First Submitted: December 21, 2021
• First Submitted That Met QC Criteria: January 27, 2022
• First Posted (Actual): January 28, 2022

Study Record Updates

• Last Update Posted (Actual): January 28, 2022
• Last Update Submitted That Met QC Criteria: January 27, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Nutrition Disorders; Musculoskeletal Diseases; Deficiency Diseases; Malnutrition; Bone Diseases; Bone Diseases, Metabolic; Calcium Metabolism Disorders; Vitamin D Deficiency; Rickets; Avitaminosis
• Other Study ID Numbers: 4750685

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No