MalnutritionNCT01161342
Nutritional Status Among Older Adults. Risk Factors and Consequences of Malnutrition
An observational study of Malnutrition, run by Uppsala University.
Trial summary
The aim of the study is to estimate the prevalence of malnutrition among older adults admitted to hospital and to analyse predictive factors for malnutrition. Further, the aim was to analyse the association between nutritional status and all-cause and cause-specific mortality. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Malnutrition
- How many people
- 1,771 participants
- Where
- No sites listed yet
- Study dates
- Mar 2008to May 2009
- 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: The included sample comprised 1771 patients 65 years and older, consecutively admitted during fifteen months to two internal medicine wards (n = 706), two surgical wards (n = 681), and one orthopaedic ward (n = 384) at the Central hospital in Västerås, Sweden.
Who may be able to join
- Patients 65 years or older
Who cannot join
- unable to communicate and no relative could anwer the questions (n = 356)
- receiving palliative care (n = 44)
- impossible to measure height or weight (n = 22)
- miscellanious (n = 71)
About this study
The aim of the study is to estimate the prevalence of malnutrition among older adults admitted to hospital and to analyse predictive factors for malnutrition. Further, the aim was to analyse the association between nutritional status and all-cause and cause-specific mortality.
The hypothesis is that malnourished patients have a higher mortality then well-nourished patients after three years.
Read the detailed description
The baseline survey was a cross-sectional study of 1771 patients aged ≥65 years who were admitted to hospital. Nutritional status was assessed using the MNA instrument, and possible risk factors associated with malnutrition were recorded during the hospital stay. All-cause mortality was followed up after median 3.5 years s in a cohort study of 1767 participants. Cause-specific mortality was followed up after median 4.7 years in a cohort of 1767 participants. Previous dietary intake in middle-aged and older adults was recorded at basline in 725 participants, who had their nutritional status assessed with the MNA when admitted to hospital 10 years later.
- Conditions
- Malnutrition
- Keywords
- Malnutrition, Aged, Aged 80 and over, Prevalence, Mortality
- Medical subject headings
- Malnutrition
What is being measured
The primary outcome is the main question the study is designed to answer.
Nutritional status according to the screening instrument Mini Nutritional Assessment (MNA)
[The 18 questions in the MNA instrument are weighted, and the threshold values of the instrument categorize patients into three nutritional status groups: well-nourished (MNA score 24-30), at risk of malnutrition (MNA score 17-23.5), or malnourished (MNA score <17).
Measured: 30 minutes
All-cause mortality
Survival was calculated from the date of the MNA screening to the date of death.
Measured: All-cause mortality was analyzed after median 3.5 years.
Cause-specific mortality
Survival was calculated from the date of the MNA screening to the date of cause-specific death.
Measured: Cause-specific mortality was analyzed after median 4.7 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2010 (estimated)
- Study startMar 2008
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe 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
- 1,771 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health and Social Affairs, Sweden
- Responsible party
- Principal investigator, Lisa Söderström, Uppsala University
- Investigators
- Leif Bergkvist, Professor, Principal investigator, The Center for Clinical research, the County Council of Vestmanland/Uppsala University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01161342
- Sponsor's protocol ID
- LTV-1211142
- Status last verified
- May 2011
- First submitted
- 12 Jul 2010
- Last updated
- 26 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Status Among Older Adults. Risk Factors and Consequences of Malnutrition
- ClinicalTrials.gov ID
- NCT01161342
- Acronym / sponsor ID
- LTV-1211142
- Conditions
- Malnutrition
- Keywords
- Malnutrition, Aged, Aged 80 and over, Prevalence, Mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,771 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Ministry of Health and Social Affairs, Sweden
- Study start
- Mar 2008
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 13 Jul 2010 (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.
The aim of the study is to estimate the prevalence of malnutrition among older adults admitted to hospital and to analyse predictive factors for malnutrition. Further, the aim was to analyse the association between nutritional status and all-cause and cause-specific mortality.
The hypothesis is that malnourished patients have a higher mortality then well-nourished patients after three years.
Detailed description
The baseline survey was a cross-sectional study of 1771 patients aged ≥65 years who were admitted to hospital. Nutritional status was assessed using the MNA instrument, and possible risk factors associated with malnutrition were recorded during the hospital stay. All-cause mortality was followed up after median 3.5 years s in a cohort study of 1767 participants. Cause-specific mortality was followed up after median 4.7 years in a cohort of 1767 participants. Previous dietary intake in middle-aged and older adults was recorded at basline in 725 participants, who had their nutritional status assessed with the MNA when admitted to hospital 10 years later.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- The included sample comprised 1771 patients 65 years and older, consecutively admitted during fifteen months to two internal medicine wards (n = 706), two surgical wards (n = 681), and one orthopaedic ward (n = 384) at the Central hospital in Västerås, Sweden.
Key inclusion criteria (1 listed)
- Patients 65 years or older
Key exclusion criteria (4 listed)
- unable to communicate and no relative could anwer the questions (n = 356)
- receiving palliative care (n = 44)
- impossible to measure height or weight (n = 22)
- miscellanious (n = 71)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Nutritional status according to the screening instrument Mini Nutritional Assessment (MNA)
Time frame: 30 minutes
[The 18 questions in the MNA instrument are weighted, and the threshold values of the instrument categorize patients into three nutritional status groups: well-nourished (MNA score 24-30), at risk of malnutrition (MNA score 17-23.5), or malnourished (MNA score <17).
All-cause mortality
Time frame: All-cause mortality was analyzed after median 3.5 years.
Survival was calculated from the date of the MNA screening to the date of death.
Cause-specific mortality
Time frame: Cause-specific mortality was analyzed after median 4.7 years.
Survival was calculated from the date of the MNA screening to the date of cause-specific death.
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 26 Aug 2015.
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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.
Leif Bergkvist, Professor principal investigator
The Center for Clinical research, the County Council of Vestmanland/Uppsala University, Sweden
Questions about this trial
What is this clinical trial studying?
An observational study of Malnutrition, run by Uppsala University.
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 1 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 26 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Nutritional status according to the screening instrument Mini Nutritional Assessment (MNA) (time frame: 30 minutes). The study lists 3 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 26 Aug 2015.