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

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.

Study Overview

• Status: Completed
• Conditions: Folic Acid Deficiency; Elderly Patients; Social Isolation
• Intervention / Treatment: Other: Lubben Social Network Scale - 6

• Study Type: Observational
• Enrollment (Actual): 61

Contacts and Locations

Study Locations

• France
  • Strasbourg, France, 67091
    • Les Hôpitaux Universitaires de Strasbourg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 73 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients over 75 years old, hospitalized in geriatric rehabilitation care in Strasbourg University Hospital

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Folic acid deficiency; Those with a folic acid defiency	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.
No deficiency; Those with no folic acid deficiency	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France
• Investigators: Principal Investigator: Catherine JEHL, Les Hôpitaux Universitaires de Strasbourg

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2020
• Primary Completion (Actual): January 23, 2020
• Study Completion (Actual): August 13, 2020

Study Registration Dates

• First Submitted: October 1, 2019
• First Submitted That Met QC Criteria: November 25, 2019
• First Posted (Actual): November 29, 2019

Study Record Updates

• Last Update Posted (Actual): September 24, 2020
• Last Update Submitted That Met QC Criteria: September 22, 2020
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Vitamin B Deficiency; Folic Acid Deficiency
• Other Study ID Numbers: 7483

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No