Effect of a Medical Food Supplement in Hospitalized Patients Recovering From Hip Fracture Surgery

Abbott Nutrition11 sites in 1 country127 target enrollmentNovember 2009

ConditionsHip Fracture

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Hip Fracture
Sponsor: Abbott Nutrition
Enrollment: 127
Locations: 11
Primary Endpoint: Blood chemistry
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of this study is to evaluate the effect of nutritional supplementation on the nutritional and clinical course of patients admitted to the hospital for hip fracture surgery.

Registry

clinicaltrials.gov

Start Date

November 2009

End Date

September 2010

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Abbott Nutrition

Eligibility Criteria

Inclusion Criteria

•Subject is \> 45 years of age.
•Subject is a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum prior to screening visit.
•Subject plans to undergo hip fracture surgery.
•Subject has anticipated length of hospital stay of at least 4 weeks. Subject is able to consume foods and beverages orally.
•Subject has admission total protein ≤ 70 g/L.
•Subject has screening serum albumin ≤ 38 g/L.

Exclusion Criteria

•Subject is known to be allergic or intolerant to any ingredient found in the study product.
•Subject has pre-planned surgery other than hip fracture surgery during the study period.
•Subject has alcohol or substance abuse, severe dementia, brain metastases, eating disorders or any psychological condition that may interfere with dietary intake, severe nausea, vomiting, diarrhea, active gastritis, gastrointestinal bleeding or other gastrointestinal disturbances.
•Subject has active malignancy
•Subject has chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
•Subject has diagnosis of IDDM.
•Subject has uncontrolled NIDDM determined by HbA1c \> 8%.