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NCT Number: NCT05214040

Vitamin D Insufficiency inVestigation Among hospitaLizeD Inpatients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Prevalence and depth of hypovitaminosis D

    Time frame: baseline

    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.

Secondary outcomes

  1. Clinical profile

    Time frame: baseline

    The clinical profile will be determine by the data provided by the physician during the hospitalization or the consultation

  2. Length of hospitalisation

    Time frame: baseline

    determine whether the circulating 25-hydroxyvitamin D concentration is associated with the length of hospitalization in days

  3. Mortality

    Time frame: baseline, 14 and 28 days, 3 and 6 months after the dosage

    determine whether the circulating 25-hydroxyvitamin D concentration is associated with the death occurring during hospital stay.

Study contacts

Contact information is provided by the study sponsor or research team.

Cédric ANNWEILER, MD,PhD

CONTACT

[email protected]

02 41 35 47 25 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Acronym: VIVALDI

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jan 28, 2022
Registry last updated
Jan 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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