Studying the Association Between Folic Acid Deficiency and Social Isolation for Elderly Patients

Social Isolation Clinical Trial

Official title:

Studying the Association Between Folic Acid Deficiency and Social Isolation for Elderly Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04180800
• Other study ID #: 7483
• Status: Completed
• Start date: January 23, 2020
• Est. completion date: August 13, 2020

Study information

• Verified date: October 2019
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Social isolation among elderly people is a frequent and major determinant for health.

The risk of premature death is 2 to 5 time higher for socially isolated people, similarly for morbidity, duration of healing and complications rate.

Denutrition is also frequent for elderly people with potentially serious consequences. Vitamin deficiency, especially in B9 and B12 vitamins, are often associated with denutrition among elderly people.

Folic acid (vitamin B9) is not influenced by inflammation and folic acid income are necessarily exogene. Vitamin B9 is provided by fresh fruits and vegetables, and giblets.

The investigators observed a high prevalence in folic acid deficiency for socially isolated elderly patients. The investigators made the hypothesis that a folic acid defiency is associated with social isolation for elderly people.

The primary purpose is the study of the association between folic acid deficiency (measured by dosing of plasma concentration of vitamin B9) and social isolation evaluated by Lubben Social Network Scale in 6 questions.

The secondary purposes are the study of the correlation between folic acid deficiency and social conditions, nutritional status, biological data, poly pharmacy, cognitive functions, dependency and length of stay at hospital.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: August 13, 2020
• Est. primary completion date: January 23, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

Inclusion criteria :

• Patients hospitalized in geriatric rehabilitation care in Strasbourg University Hospital

• Age > 75 years

• Patient has given his consent

Exclusion criteria :

• Digestive malabsorption disorder : gastrectomy, extended intestinal resection, Crohn disease, celiac disease, parenteral nutrition

• Chronic alcoholism

• Treatment with sulfamids, methotrexate, anti epileptic treatment (hydantoin)

• Hemodialysis

• Patients under protection measure (curatorship, guardianship, judicial protection)

• Patient refuses to participate

Related Conditions & MeSH terms

• Elderly Patients
• Folic Acid Deficiency
• Social Isolation

Intervention

Other:
• Lubben Social Network Scale - 6
One short oral interview to complete the Lubben Social Network Scale in auto-survey, translated in French. It contains 6 questions on 30 points, higher scores are associated with more social engagement, lower scores, specifically under 12/30, are associated with social isolation.

Locations

Country	Name	City	State
France	Les Hôpitaux Universitaires de Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure of plasma concentration on vitamin B9 by blood test taken in regular hospital admission	Folic acid deficiency is evaluated by dosing of plasma concentration of vitamin B9 through blood test taken in regular hospital admission. Folic acid deficiency is defined by a concentration under 3 ng/mL.	10 weeks
Primary	Measure of social isolation by Lubben Social Network Scale in 6 questions	Social isolation is measured by score results on LSNS-6 auto-survey. A score lower than 12/30 is associated with social isolation.	10 weeks