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Hypovitaminosis C Prevalence and Risk Factors in an Acute Geriatric Unit (HYPO-VIT-C)

Primary Purpose

Deficiency, Vitamin C

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Plasmatic Vitamin C concentrations (known as ascorbemia) on a single blood sample
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Deficiency, Vitamin C focused on measuring Vitamin C, Hypovitaminosis C, Vitamin C depletion, Vitamin C deficiency, prevalence, risk factors, geriatrics, elderlies, acute care unit

Eligibility Criteria

75 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: All patient admitted in the geriatric study acute care unit Aged more than 75 years-old. Patient able to consent having signed a consent or patient unable to give consent, informed and not opposed to the study to the study and for whom a trustworthy person, or failing that family, or failing that, a close relative, has signed an informed informed consent Patient affiliated to a social security system Exclusion Criteria: More than 7 days of hospitalization prior to the admission in the study acute care unit. Patients at the end of their life. No biological sample will be collected Patients under a "sauvegarde de justice" procedurePatients under legal protection (guardianship, curatorship, "sauvegarde de justice" procedure), Patient unable to consent without a trusted person (or family, or close friends) or without a trusted person (or family, or close friend) available within 2 days after the patient's admission.

Sites / Locations

  • Service de Médecine Gériatrique of the Hôpital Edouard Herriot (Pavillon K)Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Elderly patients

Arm Description

Only one group of patients will be constituted. It will be composed of 453 patients aged more than 75 years old and hospitalized in a geriatric acute care unit. If the patient consent to participate in the study, a 4-mL blood sample will be collected concomitantly with a general laboratory evaluation that will be performed when the patient enters the unit. No other sample will be taken., and tThe participation of the patient to the study will end after the result of the test or after the end of the vitamin C supplementation. A telephone call is organized to follow up on any adverse effectswith this blood sample collection. No further visit is organised.

Outcomes

Primary Outcome Measures

Plasmatic Vitamin C concentration (ascorbemia). It is expressed in µmol/L and determined using a laboratory assay.
Ascorbemia will be classified as follows: Normo-ascorbemia for plasmatic concentrations > 28 µmol/L. Hypovitaminosis for plasmatic concentrations < 28 µmol/L

Secondary Outcome Measures

Plasmatic Vitamin C concentration (ascorbemia). It is expressed in µmol/L and determined using a laboratory assay.
For this secondary outcome, hypovitaminosis C will be divided into two sub-groups: Vitamin C deficiency, if the ascorbemia is < 11 µmol/L Vitamin C depletion, if the ascorbemia ranges within 11-27 µmol/L
Risk factors for Hypovitaminosis C
Information will be collected about the risk factors of interest for Hypovitaminosis C: Patient identification (age, sex) Medical data (comorbidities, treatments, laboratory data from the general laboratory assessment) Consumption of tobacco or alcohol Life habits and behaviour, autonomy.
Vitamin C depletion
Vitamin C deficiency
Follow-up of adverse events in case of vitamin C supplementation.
The collection of adverse events from patients supplemented with Vitamin C either by a telephone call from the patient or from the department in which he/she is being treated.

Full Information

First Posted
December 9, 2022
Last Updated
September 21, 2023
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT05668663
Brief Title
Hypovitaminosis C Prevalence and Risk Factors in an Acute Geriatric Unit
Acronym
HYPO-VIT-C
Official Title
Hypovitaminosis C Prevalence and Risk Factors in an Acute Geriatric Unit
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 9, 2023 (Actual)
Primary Completion Date
May 24, 2024 (Anticipated)
Study Completion Date
May 24, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Vitamin C is essential for numerous biological processes as it acts as a cofactor in various hydroxylation reactions, but also as a powerful antioxidant. As humans have lost the ability to synthetize Vitamin C, this micronutrient is found exclusively in the food, and more particularly in fresh fruits and vegetables. The term 'hypovitaminosis C' refers to a plasmatic Vitamin C concentration < 28 µmol/L. It encompasses two distinct situations, according to the severity of the deprivation: A deeply lowered plasmatic concentration (< 11 µmol/L) is defined as 'Vitamin C deficiency'. The resulting condition is scurvy and its well-known haemorrhagic complications, very likely to be fatal. A less low plasmatic concentration (11-27 µmol/L) is defined as 'Vitamin C depletion'. Symptoms are polymorphic and less suggestive, especially for elderly patients. Many studies suggest a chronic Vitamin C depletion may favour the occurrence of various conditions such as cognitive impairment, psychiatric disorders, cardio-vascular diseases, or certain cancers, thereby highlighting the involvement of Vitamin C in many biological processes. The epidemiology and risk factors of hypovitaminosis C in ageing populations are poorly documented. The few studies dealing with this question are mostly retrospective, including a low number of patients, and relying on an imperfect methodology. Despite these limitations, data suggest hypovitaminosis C could concern up to 50% of the hospitalized geriatric population. Despite this probably high prevalence, hypovitaminosis C is barely diagnosed and thus rarely supplemented. This is particularly true for the elderlies who are at risk high of being Vitamin C depleted. Moreover, several risk factors have been described to be associated with Vitamin C depletion or deficiency, sometimes both. But only a few of them have been validated for the geriatric population. Thus, there is a real need for a better understanding of hypovitaminosis C epidemiology and risk factors in the geriatric population, in order to diagnose earlier, more frequently, and more precisely these cases. It is important to note that an easy and safe supplementation exists (1 g of Vitamin C for 2 weeks). A better understanding of risk factors is also a key element to apply corrective measures on modifiable risk factors in order to prevent the recurrence of hypovitaminosis C. In the present research protocol, the investigators hypothesized hypovitaminosis C could concern half of the hospitalized geriatric patients in acute care units. The primary objective of this study is to evaluate the prevalence of hypovitaminosis C in a geriatric acute care unit, by using a prospective design and including a statistically sufficient number of patients. The secondary objectives are : To determine in this population the prevalence of Vitamin C deficiency, To determine in this population the prevalence of Vitamin C depletion, To assess the statistical associations between hypovitaminosis C, deficiency, and depletion with already known or pertinent risk factors. To follow adverse events with vitamin C supplementation in deficient patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deficiency, Vitamin C
Keywords
Vitamin C, Hypovitaminosis C, Vitamin C depletion, Vitamin C deficiency, prevalence, risk factors, geriatrics, elderlies, acute care unit

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
453 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Elderly patients
Arm Type
Experimental
Arm Description
Only one group of patients will be constituted. It will be composed of 453 patients aged more than 75 years old and hospitalized in a geriatric acute care unit. If the patient consent to participate in the study, a 4-mL blood sample will be collected concomitantly with a general laboratory evaluation that will be performed when the patient enters the unit. No other sample will be taken., and tThe participation of the patient to the study will end after the result of the test or after the end of the vitamin C supplementation. A telephone call is organized to follow up on any adverse effectswith this blood sample collection. No further visit is organised.
Intervention Type
Diagnostic Test
Intervention Name(s)
Plasmatic Vitamin C concentrations (known as ascorbemia) on a single blood sample
Intervention Description
If the patient consents to participate in the study, a 4-mL blood sample will be collected and performed when the patient enters the unit. No other sample will be taken, and the participation of the patient to the study will end after the result of the test or after the end of the vitamin C supplementation. A telephone call is organized to follow up on any adverse effects. The blood sample will be collected up to 3 days after admission
Primary Outcome Measure Information:
Title
Plasmatic Vitamin C concentration (ascorbemia). It is expressed in µmol/L and determined using a laboratory assay.
Description
Ascorbemia will be classified as follows: Normo-ascorbemia for plasmatic concentrations > 28 µmol/L. Hypovitaminosis for plasmatic concentrations < 28 µmol/L
Time Frame
Day 1 : Ascorbemia will be measured only once for each patient, concomitantly with a general laboratory evaluation that will be performed when the patient enters the unit.
Secondary Outcome Measure Information:
Title
Plasmatic Vitamin C concentration (ascorbemia). It is expressed in µmol/L and determined using a laboratory assay.
Description
For this secondary outcome, hypovitaminosis C will be divided into two sub-groups: Vitamin C deficiency, if the ascorbemia is < 11 µmol/L Vitamin C depletion, if the ascorbemia ranges within 11-27 µmol/L
Time Frame
Day 1 : Ascorbemia will be measured only once for each patient, concomitantly with a general laboratory evaluation that will be performed when the patient enters the unit.
Title
Risk factors for Hypovitaminosis C
Description
Information will be collected about the risk factors of interest for Hypovitaminosis C: Patient identification (age, sex) Medical data (comorbidities, treatments, laboratory data from the general laboratory assessment) Consumption of tobacco or alcohol Life habits and behaviour, autonomy.
Time Frame
No later than Day 0 : Data are systematically collected during the initial questioning. These data are not specific to the research project.
Title
Vitamin C depletion
Time Frame
No later than Day 0 : Data are systematically collected during the initial questioning. These data are not specific to the research project.
Title
Vitamin C deficiency
Time Frame
No later than Day 0 : Data are systematically collected during the initial questioning. These data are not specific to the research project.
Title
Follow-up of adverse events in case of vitamin C supplementation.
Description
The collection of adverse events from patients supplemented with Vitamin C either by a telephone call from the patient or from the department in which he/she is being treated.
Time Frame
A call will be made no later than 45 days after the sample is taken for patients supplemented with vitamin C.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: All patient admitted in the geriatric study acute care unit Aged more than 75 years-old. Patient able to consent having signed a consent or patient unable to give consent, informed and not opposed to the study to the study and for whom a trustworthy person, or failing that family, or failing that, a close relative, has signed an informed informed consent Patient affiliated to a social security system Exclusion Criteria: More than 7 days of hospitalization prior to the admission in the study acute care unit. Patients at the end of their life. No biological sample will be collected Patients under a "sauvegarde de justice" procedurePatients under legal protection (guardianship, curatorship, "sauvegarde de justice" procedure), Patient unable to consent without a trusted person (or family, or close friends) or without a trusted person (or family, or close friend) available within 2 days after the patient's admission.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sébastien DOH, Dr
Phone
04.72.11.95.64
Email
sebastien.doh@chu-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Alfred QUILLON
Phone
04.72.11.95.64
Email
alfred.quillon@gmail.com
Facility Information:
Facility Name
Service de Médecine Gériatrique of the Hôpital Edouard Herriot (Pavillon K)
City
Lyon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sébastien DOH, Dr
Phone
04.72.11.95.64
Email
sebastien.doh@chu-lyon.fr

12. IPD Sharing Statement

Learn more about this trial

Hypovitaminosis C Prevalence and Risk Factors in an Acute Geriatric Unit

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