Hypovitaminosis DVIVALDINCT05214040
Vitamin D Insufficiency inVestigation Among hospitaLizeD Inpatients
An observational study of Hypovitaminosis D, run by University Hospital, Angers.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypovitaminosis D
- How many people
- 300,000 participants
- Where
- No sites listed yet
- Study dates
- Sep 2022to Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All consecutive patients meeting the eligibility criteria over the study period.
Who may be able to join
- ≥ 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.
Who cannot join
- None
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Conditions
- Hypovitaminosis D
- Medical subject headings
- Vitamin D Deficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline
Secondary outcomes (3)
Clinical profile
The clinical profile will be determine by the data provided by the physician during the hospitalization or the consultation
Measured: baseline
Length of hospitalisation
determine whether the circulating 25-hydroxyvitamin D concentration is associated with the length of hospitalization in days
Measured: baseline
Mortality
determine whether the circulating 25-hydroxyvitamin D concentration is associated with the death occurring during hospital stay.
Measured: baseline, 14 and 28 days, 3 and 6 months after the dosage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study startSep 2022 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypovitaminosis DStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 300,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Cédric ANNWEILER, MD,PhD, Principal investigator, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05214040
- Sponsor's protocol ID
- 4750685
- Acronym
- VIVALDI
- Status last verified
- Jan 2022
- First submitted
- 21 Dec 2021
- Last updated
- 28 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Insufficiency inVestigation Among hospitaLizeD Inpatients
- ClinicalTrials.gov ID
- NCT05214040
- Acronym / sponsor ID
- VIVALDI / 4750685
- Conditions
- Hypovitaminosis D
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300,000 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Sep 2022 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 28 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients meeting the eligibility criteria over the study period.
Key inclusion criteria (3 listed)
- ≥ 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Clinical profile
Time frame: baseline
Length of hospitalisation
Time frame: baseline
Mortality
Time frame: baseline, 14 and 28 days, 3 and 6 months after the dosage
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cédric ANNWEILER, MD,PhD principal investigator
University Hospital, Angers
Questions about this trial
What is this clinical trial studying?
An observational study of Hypovitaminosis D, run by University Hospital, Angers.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cédric ANNWEILER, MD,PhD (02 41 35 47 25 ext. +33, cedric.annweiler@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence and depth of hypovitaminosis D (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2022.