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

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ClinicalTrials.gov Identifier: NCT03807791
Recruitment Status : Completed
First Posted : January 17, 2019
Last Update Posted : September 2, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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.

Condition or disease Intervention/treatment Phase
Vitamin C Deficiency Scurvy Procedure: Blood sample Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Study of Prevalence and Risk Factors of Hypovitaminosis C in Long Term Care Unit
Actual Study Start Date : January 31, 2019
Actual Primary Completion Date : June 14, 2019
Actual Study Completion Date : June 14, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin C

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.





Primary Outcome Measures :
  1. Vitamin C plasma level [ Time Frame: Between day 0 and day 7. ]
    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.


Secondary Outcome Measures :
  1. Supposed risk factors of hypovitaminosis C [ Time Frame: Day 0 ]
    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

  2. Cutaneous symptoms [ Time Frame: Day 0 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03807791


Locations
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France
Unité de soins Longue Durée, Hôpital Pierre Garraud (Hospices Civils de Lyon)
Lyon, France, 69005
Sponsors and Collaborators
Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03807791     History of Changes
Other Study ID Numbers: 69HCL18_0392
First Posted: January 17, 2019    Key Record Dates
Last Update Posted: September 2, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Hospices Civils de Lyon:
Vitamine C deficiency
skin rash
scurvy
food texture
geriatric institution
Unit Of Long Term Care
Additional relevant MeSH terms:
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Scurvy
Avitaminosis
Ascorbic Acid Deficiency
Deficiency Diseases
Malnutrition
Nutrition Disorders
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Hematologic Diseases