Nutritional Intervention in Hip Fracture Patients

Not Applicable

Completed

• Conditions: Hip Fracture; Malnutrition
• Interventions: Dietary Supplement: Cubitan

• Registration Number: NCT00523575
• Lead Sponsor: Maastricht University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2007-08-29
• Study First Submitted QC: 2007-08-30
• Study First Posted: 2007-08-31
• Primary Completion: 2009-12
• Study Completion: 2010-06
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-19
• Last Update Posted: 2011-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
I	Cubitan	Intensive nutritional support composed of oral dietary supplement combined with dietetic counselling.

Primary Outcome Measures

Name	Time	Method
Total length of hospital stay and rehabilitation clinics	baseline, 3 months and 6 months after inclusion

Secondary Outcome Measures

Name	Time	Method
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 complications	baseline, 3 months and 6 months after inclusion

Trial Locations

Locations (3)

Atrium MC; 🇳🇱 Heerlen, Netherlands

Maaslandziekenhuis; 🇳🇱 Sittard, Netherlands

Maastricht University Hospital; 🇳🇱 Maastricht, Netherlands