Nutritional Intervention in Hip Fracture Patients
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|ClinicalTrials.gov Identifier: NCT00523575|
Recruitment Status : Completed
First Posted : August 31, 2007
Last Update Posted : July 20, 2011
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:
- Does nutritional intervention reduce total length-of-stay?
- Is nutritional intervention cost-effective?
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Hip Fracture Malnutrition||Dietary Supplement: Cubitan||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||210 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effectiveness and Cost-effectiveness of Nutritional Screening and Intervention in Elderly Subjects After Hip Fracture|
|Study Start Date :||August 2007|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||June 2010|
No Intervention: C
Usual nurse and dietetic care
Intensive nutritional support composed of oral dietary supplement combined with dietetic counselling.
Dietary Supplement: Cubitan
Other Name: Nutricia: Cubitan
- Total length of hospital stay and rehabilitation clinics [ Time Frame: baseline, 3 months and 6 months after inclusion ]
- Nutritional status, hip functionality, physical disability, fatigue, quality of life. [ Time Frame: baseline, 3 months and 6 months after inclusion ]
- Cost questionnaire, informal care questionnaire. [ Time Frame: baseline, 3 months and 6 months after inclusion ]
- Rate of complications [ Time Frame: baseline, 3 months and 6 months after inclusion ]
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): NCT00523575
|Heerlen, Netherlands, 6419 PC|
|Maastricht University Hospital|
|Maastricht, Netherlands, 6229 HA|
|Sittard, Netherlands, 6131 BK|
|Principal Investigator:||P C Dagnelie, PhD||Maastricht University - Faculty of Health Medicine and Life Sciences - Department of Epidemiologie|
|Principal Investigator:||P LM Reijven, PhD||Maastricht University Hospital - Department of Dietetics & Maastricht University - Faculty of Health Medicine and Life Sciences - Department of Epidemiology|