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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01161342
Other study ID # LTV-1211142
Secondary ID
Status Completed
Phase N/A
First received July 12, 2010
Last updated August 25, 2015
Start date March 2008
Est. completion date May 2009

Study information

Verified date May 2011
Source Uppsala University
Contact n/a
Is FDA regulated No
Health authority Sweden: Regional Ethical Review Board
Study type Observational

Clinical 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.

The hypothesis is that malnourished patients have a higher mortality then well-nourished patients after three years.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1771
Est. completion date May 2009
Est. primary completion date May 2009
Accepts healthy volunteers No
Gender Both
Age group 65 Years and older
Eligibility Inclusion Criteria:

- Patients 65 years or older

Exclusion Criteria:

- 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)

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Uppsala University Ministry of Health and Social Affairs, Sweden

Outcome

Type Measure Description Time frame Safety issue
Primary 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). 30 minutes No
Primary All-cause mortality Survival was calculated from the date of the MNA screening to the date of death. All-cause mortality was analyzed after median 3.5 years. No
Primary Cause-specific mortality Survival was calculated from the date of the MNA screening to the date of cause-specific death. Cause-specific mortality was analyzed after median 4.7 years. No
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