The Effect of When Medication is Taken on Nutritional Status in Hospitalized Patients Older Than 65 Years (MEDICANUT2)

September 5, 2016 updated by: Centre Hospitalier Universitaire Dijon

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Dijon, France, 21079
        • CHU Dijon Bourgogne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control
Biological: Blood sample
Other: Flow cytometry
Other: western blot
EMS
Biological: Blood sample
Other: Flow cytometry
Other: western blot

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
MNA short form
Time Frame: 30 days
30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Geriatric Nutritional risk form
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Primary Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

August 31, 2016

First Submitted That Met QC Criteria

September 5, 2016

First Posted (Estimate)

September 9, 2016

Study Record Updates

Last Update Posted (Estimate)

September 9, 2016

Last Update Submitted That Met QC Criteria

September 5, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • VAN WYMELBEKE 2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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