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Nutritional Intervention in Hip Fracture Patients

Effectiveness and Cost-effectiveness of Nutritional Screening and Intervention in Elderly Subjects After Hip Fracture

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00523575
Enrollment
210
Registered
2007-08-31
Start date
2007-08-31
Completion date
2010-06-30
Last updated
2011-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip Fracture, Malnutrition

Keywords

Elderly, Osteoporosis, hip fracture, malnutrition, nutritional support

Brief summary

Hip fractures are highly prevalent and are expected to increase due to the ageing population. Malnutrition is often present in these patients and is associated with prolonged convalescence, lower mobility, lower mental function, lower quality of life and higher complication rate. Nutritional intervention starting soon after hospital admission might reduce complication rate and total length-of-stay by improving nutritional and functional status. Research questions are: 1. Does nutritional intervention reduce total length-of-stay? 2. Is nutritional intervention cost-effective? 3. Can nutritional screening contribute to targeting of nutritional intervention, and thereby reduce costs without loss of effectiveness? Patients randomized to the intervention group will receive oral nutritional supplements (protein and energy enriched) and regular dietetic counselling during hospitalisation and after discharge at patients' homes for 3 months. Patients in the control group will receive usual nurse and dietetic care. Outcome measurements will be taken at baseline, 3 months and 6 months after inclusion.

Interventions

DIETARY_SUPPLEMENTCubitan

400 ml/d

Sponsors

ZonMw: The Netherlands Organisation for Health Research and Development
CollaboratorOTHER
Maastricht University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Admission to one of the participating hospitals because of a proximal femur fracture * Age 55 years and older

Exclusion criteria

* Periprosthetic or pathologic fracture * Diseases of bone metabolism, e.g. Paget, primary/secondary bone tumors, hyperparathyroidism, M. Kahler * Life expectation of less than one year due to underlying disease (e.g. cancer) * Presence of dementia or other severely impaired cognitive function * Inability to communicate in Dutch language * Nutritional intervention prior to admission * Patients who are bedridden * Patients who are too ill or for any other reason not able to participate adequately in follow-up

Design outcomes

Primary

MeasureTime frame
Total length of hospital stay and rehabilitation clinicsbaseline, 3 months and 6 months after inclusion

Secondary

MeasureTime frame
Nutritional status, hip functionality, physical disability, fatigue, quality of life.baseline, 3 months and 6 months after inclusion
Cost questionnaire, informal care questionnaire.baseline, 3 months and 6 months after inclusion
Rate of complicationsbaseline, 3 months and 6 months after inclusion

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026