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Effects of Nutritional Supplementation and Dietary Advice in Elderly Patients After Hospital Discharge.

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ClinicalTrials.gov Identifier: NCT01057914
Recruitment Status : Active, not recruiting
First Posted : January 28, 2010
Last Update Posted : October 11, 2018
Sponsor:
Collaborator:
Västmanland County Council, Sweden
Information provided by (Responsible Party):
Uppsala University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Malnutrition Dietary Supplement: Nutritional supplementation with a liquid formula Other: Dietary advice Other: Combination of supplement and dietary advice Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : February 2010
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Supplemention Dietary Supplement: Nutritional supplementation with a liquid formula
The patient consumes 400 kcal from a liquid supplementation formula
Experimental: Dietary advice Other: Dietary advice
The patient receives dietary advice for one hour during the hospital stay.
Experimental: Combination treatment Other: Combination of supplement and dietary advice
The patient receives dietary advice for one hour during the hospital stay and consumes 400 kcal from liquid supplementation formula for six month after discharge.
No Intervention: Usual care


Outcome Measures
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Primary Outcome Measures :
  1. All cause mortality [ Time Frame: Six months, one year, three years ]

Secondary Outcome Measures :
  1. Health-related quality of life [ Time Frame: Six months, one year, three years ]
  2. Health-care consumption [ Time Frame: Six months, one year, three years ]
  3. Function in activities in daily life [ Time Frame: Six months, one year, three years ]

Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01057914


Locations
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Sweden
Falu lasarett
Falun, Dalarna, Sweden, 79129
Mälarsjukhuset in Eskilstuna
Eskilstuna, Sörmland, Sweden, 61188
Nyköpings lasarett
Nyköping, Sörmland, Sweden, 61188
Akademiska sjukhuset
Uppsala, Uppland, Sweden, 75125
Västmanlands sjukhus Västerås
Västerås, Västmanland, Sweden, 72189
Sponsors and Collaborators
Uppsala University
Västmanland County Council, Sweden
Investigators
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Principal Investigator: Leif Bergkvist Centre for clinical research, Landstinget Västmanland/Uppsala University
More Information
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Responsible Party: Uppsala University
ClinicalTrials.gov Identifier: NCT01057914     History of Changes
Other Study ID Numbers: LTV-69151
First Posted: January 28, 2010    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Keywords provided by Uppsala University:
Randomized controlled trial
Malnutrition
Aged
Aged 80 and over
Nutrition therapy
Additional relevant MeSH terms:
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Malnutrition
Nutrition Disorders