NCT02894827

Brief Summary

Polypathology in elderly subjects requires polypharmacy but even though the efficacy of a medication and digestive tolerance are ensured, the medication can be taken a long time from meals to reduce its side-effects. Despite numerous studies that have investigated links between medication and malnutrition, none have assessed the influence of the time the drug is taken on the evolution of the nutritional status of elderly hospitalized persons. So as to identify the best nutritional criterion in hospitalized persons, a retrospective pilot study will be conducted in about thirty patients. Their medication will be recorded and their nutritional status will be evaluated using the Geriatric Nutritional Risk Index (GNRI), albumin, prealbumin levels, weight and the Mini Nutritional Assessment (MNA) short form. This preliminary study will allow us to choose the best nutritional criterion to compare the impact of two strategies for taking medication (post prandial versus pre-prandial) on improving the nutritional status of malnourished elderly hospitalized patients taking multiple drugs.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

August 31, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 9, 2016

Completed
Last Updated

September 9, 2016

Status Verified

September 1, 2016

First QC Date

August 31, 2016

Last Update Submit

September 5, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • MNA short form

    30 days

Secondary Outcomes (1)

  • Geriatric Nutritional risk form

    30 days

Study Arms (2)

EMS

Biological: Blood sampleOther: Flow cytometryOther: western blot

Control

Biological: Blood sampleOther: Flow cytometryOther: western blot

Interventions

Blood sampleBIOLOGICAL
ControlEMS
ControlEMS
ControlEMS

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with a stable or controlled acute disease hospitalized in a geriatric follow-up care unit

You may qualify if:

  • patients aged 65 years or more.
  • patients with a stable or controlled acute disease hospitalized in a geriatric follow-up care unit.
  • patients whose life expectancy is greater than 30 days.
  • patients able to eat food normally.
  • patients able to swallow their medication.
  • patients with at least 3 drugs to be taken orally per day, not including oral nutritional supplements.

You may not qualify if:

  • patients at the end of life.
  • patients whose drugs must be taken before meals like Non-steroid anti-inflammatory drugs (NSAIDs), glinides, oral antidiabetic agents (OAD).
  • patients with parenteral and/or enteral nutrition in the period preceding admission to the geriatric unit.
  • patients with indications for parental and/or enteral nutrition.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Dijon Bourgogne

Dijon, 21079, France

Location

MeSH Terms

Interventions

Blood Specimen CollectionFlow CytometryBlotting, Western

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesCell SeparationCytological TechniquesCytophotometryFluorometryLuminescent MeasurementsPhotometryChemistry Techniques, AnalyticalElectrophoresisElectrochemical TechniquesImmunoblottingImmunoassayImmunologic TechniquesMolecular Probe Techniques

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2016

First Posted

September 9, 2016

Primary Completion

September 1, 2015

Last Updated

September 9, 2016

Record last verified: 2016-09

Locations