Nutritional Intervention in Hip Fracture Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2010-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Hip Fracture Malnutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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C

Usual nurse and dietetic care

Group Type NO_INTERVENTION

No interventions assigned to this group

I

Intensive nutritional support composed of oral dietary supplement combined with dietetic counselling.

Group Type EXPERIMENTAL

Cubitan

Intervention Type DIETARY_SUPPLEMENT

400 ml/d

Interventions

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Cubitan

400 ml/d

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Nutricia: Cubitan

Eligibility Criteria

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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

Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Maastricht University

Principal Investigators

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P C Dagnelie, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University - Faculty of Health Medicine and Life Sciences - Department of Epidemiologie

P LM Reijven, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Hospital - Department of Dietetics & Maastricht University - Faculty of Health Medicine and Life Sciences - Department of Epidemiology