Nutritional StatusMEDICANUT2NCT02894827
The Effect of When Medication is Taken on Nutritional Status in Hospitalized Patients Older Than 65 Years
An observational study of Nutritional Status, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Nutritional Status
- What is being tested?
- Blood sample, Flow cytometry and western blot
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Start not givento Sep 2015
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: patients with a stable or controlled acute disease hospitalized in a geriatric follow-up care unit
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Nutritional Status
- Being tested
- Blood sample, Flow cytometry, western blot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleBiological
Flow cytometryOther
western blotOther
| Study group | Role | What they receive |
|---|---|---|
| EMS | Not described Receives: Biological: Blood sample; Other: Flow cytometry; Other: western blot | |
| Control | Not described Receives: Biological: Blood sample; Other: Flow cytometry; Other: western blot |
What is being measured
The primary outcome is the main question the study is designed to answer.
MNA short form
Measured: 30 days
Secondary outcomes (1)
Geriatric Nutritional risk form
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Primary completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutritional StatusStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02894827
- Sponsor's protocol ID
- VAN WYMELBEKE 2015
- Acronym
- MEDICANUT2
- Status last verified
- Sep 2016
- First submitted
- 31 Aug 2016
- Last updated
- 9 Sep 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of When Medication is Taken on Nutritional Status in Hospitalized Patients Older Than 65 Years
- ClinicalTrials.gov ID
- NCT02894827
- Acronym / sponsor ID
- MEDICANUT2 / VAN WYMELBEKE 2015
- Conditions
- Nutritional Status
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Primary completion
- Sep 2015 (actual)
- First posted
- 9 Sep 2016 (estimated)
- 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.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EMS | – | Biological: Blood sample, Other: Flow cytometry, Other: western blot |
| Control | – | Biological: Blood sample, Other: Flow cytometry, Other: western blot |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- patients with a stable or controlled acute disease hospitalized in a geriatric follow-up care unit
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Blood sample | Biological | Control, EMS |
| Flow cytometry | Other | Control, EMS |
| western blot | Other | Control, EMS |
Primary outcome
MNA short form
Time frame: 30 days
1 secondary outcome
Geriatric Nutritional risk form
Time frame: 30 days
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 9 Sep 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Nutritional Status, run by Centre Hospitalier Universitaire Dijon 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 6 inclusion and 4 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 9 Sep 2016. 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?
MNA short form (time frame: 30 days). 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 9 Sep 2016.