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

Nutritional Status Clinical Trial

— MEDICANUT2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02894827
• Other study ID #: VAN WYMELBEKE 2015
• Status: Completed
• Phase: N/A
• First received: August 31, 2016
• Last updated: September 5, 2016

Study information

• Verified date: September 2016
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Nutritional Status

Intervention

Biological:
• Blood sample

Other:
• Flow cytometry

• western blot

Locations

Country	Name	City	State
France	CHU Dijon Bourgogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MNA short form		30 days	No
Secondary	Geriatric Nutritional risk form		30 days	No