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

Vitamin C Deficiency Clinical Trial

— Vitamin C  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03807791
• Other study ID #: 69HCL18_0392
• Status: Completed
• Phase: N/A
• Start date: January 31, 2019
• Est. completion date: June 14, 2019

Study information

• Verified date: August 2019
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 14, 2019
• Est. primary completion date: June 14, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ascorbic Acid Deficiency
• Avitaminosis
• Scurvy
• Vitamin C Deficiency

Intervention

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.

Locations

Country	Name	City	State
France	Unité de soins Longue Durée, Hôpital Pierre Garraud (Hospices Civils de Lyon)	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Cutaneous symptoms		Day 0