Nutritional Intervention in Hip Fracture Patients

This study has been completed.
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00523575
First received: August 29, 2007
Last updated: July 19, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention
Hip Fracture
Malnutrition
Dietary Supplement: Cubitan

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effectiveness and Cost-effectiveness of Nutritional Screening and Intervention in Elderly Subjects After Hip Fracture

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Total length of hospital stay and rehabilitation clinics [ Time Frame: baseline, 3 months and 6 months after inclusion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Nutritional status, hip functionality, physical disability, fatigue, quality of life. [ Time Frame: baseline, 3 months and 6 months after inclusion ] [ Designated as safety issue: No ]
  • Cost questionnaire, informal care questionnaire. [ Time Frame: baseline, 3 months and 6 months after inclusion ] [ Designated as safety issue: No ]
  • Rate of complications [ Time Frame: baseline, 3 months and 6 months after inclusion ] [ Designated as safety issue: No ]

Estimated Enrollment: 210
Study Start Date: August 2007
Study Completion Date: June 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: C
Usual nurse and dietetic care
Experimental: I
Intensive nutritional support composed of oral dietary supplement combined with dietetic counselling.
Dietary Supplement: Cubitan
400 ml/d
Other Name: Nutricia: Cubitan

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00523575

Locations
Netherlands
Atrium MC
Heerlen, Netherlands, 6419 PC
Maastricht University Hospital
Maastricht, Netherlands, 6229 HA
Maaslandziekenhuis
Sittard, Netherlands, 6131 BK
Sponsors and Collaborators
Maastricht University Medical Center
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
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
  More Information

No publications provided by Maastricht University Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: PC Dagnelie, PhD, Maastricht University
ClinicalTrials.gov Identifier: NCT00523575     History of Changes
Other Study ID Numbers: MEC 06-3-098, ZonMw 80-007022-98-07510
Study First Received: August 29, 2007
Last Updated: July 19, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
Elderly
Osteoporosis
hip fracture
malnutrition
nutritional support

Additional relevant MeSH terms:
Fractures, Bone
Malnutrition
Nutrition Disorders
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries

ClinicalTrials.gov processed this record on September 16, 2014