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
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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 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 |

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 |
- All cause mortality [ Time Frame: Six months, one year, three years ]
- Health-related quality of life [ Time Frame: Six months, one year, three years ]
- Health-care consumption [ Time Frame: Six months, one year, three years ]
- Function in activities in daily life [ Time Frame: Six months, one year, three years ]

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Ages Eligible for Study: | 65 Years and older (Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
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 |
Principal Investigator: | Leif Bergkvist | Centre for clinical research, Landstinget Västmanland/Uppsala University |
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 |
Randomized controlled trial Malnutrition Aged Aged 80 and over Nutrition therapy |
Malnutrition Nutrition Disorders |