Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Västmanland County Council, Sweden
Information provided by (Responsible Party):
Uppsala University
ClinicalTrials.gov Identifier:
NCT01057914
First received: January 27, 2010
Last updated: January 12, 2012
Last verified: January 2012
  Purpose

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 Intervention
Malnutrition
Dietary Supplement: Nutritional supplementation with a liquid formula
Other: Dietary advice
Other: Combination of supplement and dietary advice

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Uppsala University:

Primary Outcome Measures:
  • All cause mortality [ Time Frame: Six months, one year, three years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Health-related quality of life [ Time Frame: Six months, one year, three years ] [ Designated as safety issue: No ]
  • Health-care consumption [ Time Frame: Six months, one year, three years ] [ Designated as safety issue: No ]
  • Function in activities in daily life [ Time Frame: Six months, one year, three years ] [ Designated as safety issue: No ]

Estimated Enrollment: 800
Study Start Date: February 2010
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01057914

Locations
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
Principal Investigator: Leif Bergkvist Centre for clinical research, Landstinget Västmanland/Uppsala University
  More Information

No publications provided

Responsible Party: Uppsala University
ClinicalTrials.gov Identifier: NCT01057914     History of Changes
Other Study ID Numbers: LTV-69151
Study First Received: January 27, 2010
Last Updated: January 12, 2012
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Uppsala University:
Randomized controlled trial
Malnutrition
Aged
Aged 80 and over
Nutrition therapy

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on November 24, 2014