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OpenTrials
Completed

NCT Number: NCT04180800

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.

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Key information

Age range

75 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Les Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Measure of plasma concentration on vitamin B9 by blood test taken in regular hospital admission

    Time frame: 10 weeks

    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.

  2. Measure of social isolation by Lubben Social Network Scale in 6 questions

    Time frame: 10 weeks

    Social isolation is measured by score results on LSNS-6 auto-survey. A score lower than 12/30 is associated with social isolation.

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Nov 29, 2019
Registry last updated
Sep 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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