Study of Prevalence and Risk Factors of Hypovitaminosis C in Long Term Care Unit (Vitamin C)

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.

Study Overview

• Status: Completed
• Conditions: Vitamin C Deficiency; Scurvy
• Intervention / Treatment: Procedure: Blood sample

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69005
    • Unité de soins Longue Durée, Hôpital Pierre Garraud (Hospices Civils de Lyon)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Procedure: Blood sample; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Between day 0 and day 7.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Day 0
Cutaneous symptoms		Day 0

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2019
• Primary Completion (Actual): June 14, 2019
• Study Completion (Actual): June 14, 2019

Study Registration Dates

• First Submitted: January 15, 2019
• First Submitted That Met QC Criteria: January 15, 2019
• First Posted (Actual): January 17, 2019

Study Record Updates

• Last Update Posted (Actual): September 3, 2019
• Last Update Submitted That Met QC Criteria: August 29, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Vitamine C deficiency; skin rash; scurvy; food texture; geriatric institution; Unit Of Long Term Care
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hematologic Diseases; Nutrition Disorders; Hemorrhagic Disorders; Hemostatic Disorders; Deficiency Diseases; Malnutrition; Avitaminosis; Scurvy; Ascorbic Acid Deficiency
• Other Study ID Numbers: 69HCL18_0392

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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