NCT03807791

Brief Summary

The clinical finding of skin rashes which appear after a vitamin C deficiency in Long Term Care Unit leads us to believe that the institutional diet could predispose to this kind of deficiency. Vitamin C has a key role into the struggle against oxidant stress and is involved into the connective tissue formation of the skin and the vascular endothelium. Vitamin C deficiency affects currently 15 to 25% of the elderly over 65 years old reaching 15% women and 20% men after 65 according to Johnston and Al. It concerns mainly the people in precarious situations (persons without fixed homes, ethyl-smoking persons) and elderly over 65 years. Hypovitaminosis C, defined by plasma level between 5 mg/L and 15 mg/L (28.41 to 85.23 µmol/L), is currently undiagnosed, especially with people with a risk of food deficiency and its prevalence increases with age. The treatment consists of a daily oral supplementation of 1 gram of vitamin C/d for 15 days. A minimum intake of 10 mg/D of vitamin C is required to prevent scurvy and maintain a total pool of 350 mg. A diet modification by a systematic intake of 2 glasses of fresh orange juice and/or the consumption of raw fruits and vegetables would prevent the appearance of scurvy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 17, 2019

Completed
14 days until next milestone

Study Start

First participant enrolled

January 31, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2019

Completed
Last Updated

September 3, 2025

Status Verified

August 1, 2025

Enrollment Period

4 months

First QC Date

January 15, 2019

Last Update Submit

August 26, 2025

Conditions

Keywords

Vitamine C deficiencyskin rashscurvyfood texturegeriatric institutionUnit Of Long Term Care

Outcome Measures

Primary Outcomes (1)

  • Vitamin C plasma level

    1. ) Collection of the consent 2. ) At the same time as other analysis for current cares a blood sample taken by a nurse of our unit to determine plasma levels of vitamin C. 3. ) Registration of risk factors of vitamin C deficiency. . 4. ) Doing a clinical exam within 7 days after the blood sample.

    Between day 0 and day 7.

Secondary Outcomes (2)

  • Supposed risk factors of hypovitaminosis C

    Day 0

  • Cutaneous symptoms

    Day 0

Study Arms (1)

Patient living in the Unit of Long Term Care

EXPERIMENTAL

Patient living in the Unit of Long Term Care without any limit time

Procedure: Blood sample

Interventions

Blood samplePROCEDURE

A blood sample will be taken by the nurse of our unit within a week after their consent. It consists as a simple blood sample and it will be taken during the normal analysis planed by the chief of the service in order to avoid to collect two different samples. The measurement method will use equipment from the Lyon Sud hospital laboratory. The samples need a pre-treatment in the 3 hours after taking the blood to avoid the oxidation of vitamin C and a result lower than expected.

Patient living in the Unit of Long Term Care

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Male or female over 65 years old
  • living in the Unit of Long Term Care without any limit time.
  • with a system of social insurance
  • Who gave its consent by his own , or with help of his representant or his tutor or curator.

You may not qualify if:

  • rejection of the blood sample
  • patient feeding with articial nutritional feeding (stomach tube feeding)
  • person close to death, who is not able to feed himself and / or with life-threatening in short time.
  • Patient with personal history of vitamin C deficiency.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unité de soins Longue Durée, Hôpital Pierre Garraud (Hospices Civils de Lyon)

Lyon, 69005, France

Location

Related Publications (1)

  • Lagorsse C., Oumédian E., Bourguignon L, de La Gastine B. Les carences en vitamine C, une cause peu connue d'affections cutanées en institution gériatrique : à propos de 2 cas en Unité de Soins de Longue Durée (USLD). Rev Geriatr 2019 Février 44 2.

    BACKGROUND

MeSH Terms

Conditions

Ascorbic Acid DeficiencyScurvyExanthema

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic DiseasesHemostatic DisordersVascular DiseasesCardiovascular DiseasesHemorrhagic DisordersHematologic DiseasesHemic and Lymphatic DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2019

First Posted

January 17, 2019

Study Start

January 31, 2019

Primary Completion

June 14, 2019

Study Completion

June 14, 2019

Last Updated

September 3, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations