Study of Prevalence and Risk Factors of Hypovitaminosis C in Long Term Care Unit (Vitamin C)
Primary Purpose
Vitamin C Deficiency, Scurvy
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sample
Sponsored by
About this trial
This is an interventional prevention trial for Vitamin C Deficiency focused on measuring Vitamine C deficiency, skin rash, scurvy, food texture, geriatric institution, Unit Of Long Term Care
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Unité de soins Longue Durée, Hôpital Pierre Garraud (Hospices Civils de Lyon)
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patient living in the Unit of Long Term Care
Arm Description
Patient living in the Unit of Long Term Care without any limit time
Outcomes
Primary Outcome Measures
Vitamin C plasma level
) Collection of the consent
) 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.
) Registration of risk factors of vitamin C deficiency. .
) Doing a clinical exam within 7 days after the blood sample.
Secondary Outcome Measures
Supposed risk factors of hypovitaminosis C
The supposed risk factors are represent by general risk factors, Anthropometric parameters, Nutritional risk factors, Risk factors because of Unit of Long Term Care, Pathologies associated, Clinical signs associated with vitamin C deficiency
Cutaneous symptoms
Full Information
NCT ID
NCT03807791
First Posted
January 15, 2019
Last Updated
August 29, 2019
Sponsor
Hospices Civils de Lyon
1. Study Identification
Unique Protocol Identification Number
NCT03807791
Brief Title
Study of Prevalence and Risk Factors of Hypovitaminosis C in Long Term Care Unit
Acronym
Vitamin C
Official Title
Study of Prevalence and Risk Factors of Hypovitaminosis C in Long Term Care Unit
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
January 31, 2019 (Actual)
Primary Completion Date
June 14, 2019 (Actual)
Study Completion Date
June 14, 2019 (Actual)
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
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin C Deficiency, Scurvy
Keywords
Vitamine C deficiency, skin rash, scurvy, food texture, geriatric institution, Unit Of Long Term Care
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patient living in the Unit of Long Term Care
Arm Type
Experimental
Arm Description
Patient living in the Unit of Long Term Care without any limit time
Intervention Type
Procedure
Intervention Name(s)
Blood sample
Intervention Description
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.
Primary Outcome Measure Information:
Title
Vitamin C plasma level
Description
) Collection of the consent
) 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.
) Registration of risk factors of vitamin C deficiency. .
) Doing a clinical exam within 7 days after the blood sample.
Time Frame
Between day 0 and day 7.
Secondary Outcome Measure Information:
Title
Supposed risk factors of hypovitaminosis C
Description
The supposed risk factors are represent by general risk factors, Anthropometric parameters, Nutritional risk factors, Risk factors because of Unit of Long Term Care, Pathologies associated, Clinical signs associated with vitamin C deficiency
Time Frame
Day 0
Title
Cutaneous symptoms
Time Frame
Day 0
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Facility Information:
Facility Name
Unité de soins Longue Durée, Hôpital Pierre Garraud (Hospices Civils de Lyon)
City
Lyon
ZIP/Postal Code
69005
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study of Prevalence and Risk Factors of Hypovitaminosis C in Long Term Care Unit
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