Folic Acid DeficiencyNCT04180800
Studying the Association Between Folic Acid Deficiency and Social Isolation for Elderly Patients
An observational study of Folic Acid Deficiency and Social Isolation, run by University Hospital, Strasbourg, France at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Folic Acid Deficiency, Social Isolation, Elderly Patients
- What is being tested?
- Lubben Social Network Scale - 6
- Type of treatment
- Pill or oral medicine
- How many people
- 61 participants
- Where
- 1 siteFrance
- Study dates
- 23 Jan 2020to 13 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients over 75 years old, hospitalized in geriatric rehabilitation care in Strasbourg University Hospital
Who may be able to join
- Patients hospitalized in geriatric rehabilitation care in Strasbourg University Hospital
- Age > 75 years
- Patient has given his consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- Lubben Social Network Scale - 6
- Medical subject headings
- Folic Acid Deficiency, Social Isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lubben Social Network Scale - 6Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Folic acid deficiency | Those with a folic acid defiency Receives: Other: Lubben Social Network Scale - 6 | |
| No deficiency | Those with no folic acid deficiency Receives: Other: Lubben Social Network Scale - 6 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2019
- Study start23 Jan 2020
- Primary completion23 Jan 2020
- Study completion13 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Folic Acid DeficiencyStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine JEHL, Principal investigator, Les Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04180800
- Sponsor's protocol ID
- 7483
- Status last verified
- Oct 2019
- First submitted
- 1 Oct 2019
- Last updated
- 24 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studying the Association Between Folic Acid Deficiency and Social Isolation for Elderly Patients
- ClinicalTrials.gov ID
- NCT04180800
- Acronym / sponsor ID
- 7483
- Conditions
- Folic Acid Deficiency, Social Isolation, Elderly Patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 23 Jan 2020 (actual)
- Primary completion
- 23 Jan 2020 (actual)
- Study completion
- 13 Aug 2020 (actual)
- First posted
- 29 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Folic acid deficiency | – | Other: Lubben Social Network Scale - 6Those with a folic acid defiency |
| No deficiency | – | Other: Lubben Social Network Scale - 6Those with no folic acid deficiency |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients over 75 years old, hospitalized in geriatric rehabilitation care in Strasbourg University Hospital
Key inclusion criteria (3 listed)
- Patients hospitalized in geriatric rehabilitation care in Strasbourg University Hospital
- Age > 75 years
- Patient has given his consent
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lubben Social Network Scale - 6One 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. | Other | Folic acid deficiency, No deficiency |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine JEHL principal investigator
Les Hôpitaux Universitaires de Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Folic Acid Deficiency and Social Isolation, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of plasma concentration on vitamin B9 by blood test taken in regular hospital admission (time frame: 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2020.