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

NCT04180800 | Completed

• 1 other identifier: 7483
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Folic Acid Deficiency; Social Isolation; Elderly Patients

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Folic acid deficiency

Those with a folic acid defiency

Other: Lubben Social Network Scale - 6

No deficiency

Those with no folic acid deficiency

Other: Lubben Social Network Scale - 6

Interventions

Lubben Social Network Scale - 6 OTHER

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.

Folic acid deficiency; No deficiency

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Patients hospitalized in geriatric rehabilitation care in Strasbourg University Hospital
• Age \> 75 years
• Patient has given his consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Les Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Location

MeSH Terms

Conditions

Folic Acid Deficiency; Social Isolation

Condition Hierarchy (Ancestors)

Vitamin B Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Social Behavior; Behavior

Study Officials

• Catherine JEHL

  Les Hôpitaux Universitaires de Strasbourg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2019
• First Posted: November 29, 2019
• Study Start: January 23, 2020
• Primary Completion: January 23, 2020
• Study Completion: August 13, 2020
• Last Updated: September 24, 2020

Record last verified: 2019-10

Locations

FR (1)