Clinical trial NCT01057914: Effects of Nutritional Supplementation and Dietary Advice in Elderly Patients After Hospital Discharge.
Official title: Effects of Six Months Treatment With Nutritional Supplements or Dietary Advice, Alone or in Combination on Mortality, Health-related Quality of Life and Health-care Consumption for Elderly Patients at Risk of Malnutrition.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Keywords: Randomized controlled trial
Malnutrition
Aged
Aged 80 and over
Nutrition therapy
Lead sponsor: Uppsala University
Sponsor class: OTHER
Collaborators: name: Västmanland County Council, Sweden
First posted: 2010-01-28
Enrollment: 671
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effects of nutritional therapy in elderly malnourished patients. The hypothesises are that nutritional supplementation and dietary advice alone or in combination affects mortality, quality of life and health-care consumption after six month of treatment.


Eligibility criteria: Inclusion Criteria:

* ≥65 years old
* Admitted to one of the participating wards during the recruitment period

Exclusion Criteria:

* Well-nourished
* No consent to participate
* Not able to communicate
* Not able to understand swedish
* Presumed life-expectancy \<1 year
* Already receiving nutritional therapy including dietary advice, supplements, tube-feeding or parenteral nutrition
* Dietary restrictions due to illness or disease inconsistent with the intervention
* Impaired cognitive function or dementia
* Body mass index ≥35
* Living in old peoples homes, sheltered housing, institution, service flats or nursing homes
* Participant in a study evaluating differences in 3-year mortality between well-nourished patients, patients at risk of malnutrition and malnourished patients

Primary outcomes:
measure: All cause mortality
timeFrame: Six months, one year, three years
Secondary outcomes:
measure: Health-related quality of life
timeFrame: Six months, one year, three years
measure: Health-care consumption
timeFrame: Six months, one year, three years
measure: Function in activities in daily life
timeFrame: Six months, one year, three years
Other outcomes:
Locations:
city: Falun
country: Sweden
facility: Falu lasarett
state: Dalarna
city: Eskilstuna
country: Sweden
facility: Mälarsjukhuset in Eskilstuna
state: Sörmland
city: Nyköping
country: Sweden
facility: Nyköpings lasarett
state: Sörmland
city: Uppsala
country: Sweden
facility: Akademiska sjukhuset
state: Uppland
city: Västerås
country: Sweden
facility: Västmanlands sjukhus Västerås
state: Västmanland
Study officials:
affiliation: Centre for clinical research, Landstinget Västmanland/Uppsala University
name: Leif Bergkvist
role: PRINCIPAL_INVESTIGATOR
References:
citation: Soderstrom L, Rosenblad A, Bergkvist L, Frid H, Thors Adolfsson E. Dietary advice and oral nutritional supplements do not increase survival in older malnourished adults: a multicentre randomised controlled trial. Ups J Med Sci. 2020 Aug;125(3):240-249. doi: 10.1080/03009734.2020.1751752. Epub 2020 May 2.