Deficiency, Vitamin CHYPO-VIT-CNCT05668663
Hypovitaminosis C Prevalence and Risk Factors in an Acute Geriatric Unit
A study testing Plasmatic Vitamin C concentrations (known as ascorbemia) on a single blood sample in people with Deficiency, Vitamin C, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 75 years and olderHealthy volunteers can take part
- Conditions the study is for
- Deficiency, Vitamin C
- What is being tested?
- Plasmatic Vitamin C concentrations (known as ascorbemia) on a single blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 434 participants
- Where
- 1 siteFrance
- Study dates
- 9 Jan 2023to 24 May 2024
- Phase
- Interventional
- 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 75 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Médecine Gériatrique of the Hôpital Edouard Herriot (Pavillon K)
Lyon
About this study
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:
Read more
- 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.
- Conditions
- Deficiency, Vitamin C
- Being tested
- Plasmatic Vitamin C concentrations (known as ascorbemia) on a single blood sample
- Keywords
- Vitamin C, Hypovitaminosis C, Vitamin C depletion, Vitamin C deficiency, prevalence, risk factors, geriatrics, elderlies, acute care unit
- Medical subject headings
- Ascorbic Acid Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasmatic Vitamin C concentrations (known as ascorbemia) on a single blood sampleDiagnostic test
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
| Study group | Role | What they receive |
|---|---|---|
| Elderly patients | Experimental | 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. Receives: Diagnostic Test: Plasmatic Vitamin C concentrations (known as ascorbemia) on a single blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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 outcomes (5)
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
Measured: 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.
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.
Measured: No later than Day 0 : Data are systematically collected during the initial questioning. These data are not specific to the research project.
Vitamin C depletion
Measured: No later than Day 0 : Data are systematically collected during the initial questioning. These data are not specific to the research project.
Vitamin C deficiency
Measured: No later than Day 0 : Data are systematically collected during the initial questioning. These data are not specific to the research project.
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.
Measured: A call will be made no later than 45 days after the sample is taken for patients supplemented with vitamin C.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2022
- Study start9 Jan 2023
- Primary completion24 May 2024
- Study completion24 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Deficiency, Vitamin CStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 434 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05668663
- Sponsor's protocol ID
- 69HCL22_0883
- Other IDs
- 2022-A02234-39
- Acronym
- HYPO-VIT-C
- Status last verified
- Aug 2025
- First submitted
- 9 Dec 2022
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Quillon A, Guittard L, Goldet K, Etienne M, Blond E, Nourredine M, Martin-Gaujard G, Doh S. A cross-sectional study to evaluate hypovitaminosis C prevalence and risk factors in an acute geriatric unit in Lyon, France: the HYPO-VIT-C protocol. BMJ Open. 2023 Aug 23;13(8):e075924. doi: 10.1136/bmjopen-2023-075924.
PubMed 37612102
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypovitaminosis C Prevalence and Risk Factors in an Acute Geriatric Unit
- ClinicalTrials.gov ID
- NCT05668663
- Acronym / sponsor ID
- HYPO-VIT-C / 69HCL22_0883
- Conditions
- Deficiency, Vitamin C
- Keywords
- Vitamin C, Hypovitaminosis C, Vitamin C depletion, Vitamin C deficiency, prevalence, risk factors, geriatrics, elderlies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 434 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- 24 May 2024 (actual)
- Study completion
- 24 May 2024 (actual)
- First posted
- 30 Dec 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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elderly patients | Experimental | Diagnostic Test: Plasmatic Vitamin C concentrations (known as ascorbemia) on a single blood sampleOnly 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. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plasmatic Vitamin C concentrations (known as ascorbemia) on a single blood sampleIf 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 | Diagnostic test | Elderly patients |
Primary outcome
Plasmatic Vitamin C concentration (ascorbemia). It is expressed in µmol/L and determined using a laboratory assay.
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.
Ascorbemia will be classified as follows: * Normo-ascorbemia for plasmatic concentrations > 28 µmol/L. * Hypovitaminosis for plasmatic concentrations < 28 µmol/L
5 secondary outcomes
Plasmatic Vitamin C concentration (ascorbemia). It is expressed in µmol/L and determined using a laboratory assay.
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.
Risk factors for Hypovitaminosis C
Time frame: No later than Day 0 : Data are systematically collected during the initial questioning. These data are not specific to the research project.
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.
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.
Follow-up of adverse events in case of vitamin C supplementation.
Time frame: A call will be made no later than 45 days after the sample is taken for patients supplemented with vitamin C.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Background: PubMed 37612102Quillon A, Guittard L, Goldet K, Etienne M, Blond E, Nourredine M, Martin-Gaujard G, Doh S. A cross-sectional study to evaluate hypovitaminosis C prevalence and risk factors in an acute geriatric unit in Lyon, France: the HYPO-VIT-C protocol. BMJ Open. 2023 Aug 23;13(8):e075924. doi: 10.1136/bmjopen-2023-075924.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plasmatic Vitamin C concentrations (known as ascorbemia) on a single blood sample in people with Deficiency, Vitamin C, run by Hospices Civils de Lyon at 1 site in France.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasmatic Vitamin C concentration (ascorbemia). It is expressed in µmol/L and determined using a laboratory assay. (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05668663, which also lists 1 linked publication.
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 3 Sep 2025.