NCT01057914
Completed
N/A
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.
Uppsala University5 sites in 1 country671 target enrollmentFebruary 2010
ConditionsMalnutrition
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Malnutrition
- Sponsor
- Uppsala University
- Enrollment
- 671
- Locations
- 5
- Primary Endpoint
- All cause mortality
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
All cause mortality
Time Frame: Six months, one year, three years
Secondary Outcomes
- Health-care consumption(Six months, one year, three years)
- Health-related quality of life(Six months, one year, three years)
- Function in activities in daily life(Six months, one year, three years)
Study Sites (5)
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