Clinical trial NCT01011608: Effect of a Medical Food Supplement in Hospitalized Patients Recovering From Surgery
Official title: Effect of a Medical Food Supplement in Hospitalized Patients Recovering From Hip Fracture Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hip Fracture
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2009-11-11
Enrollment: 127
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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%.

Primary outcomes:
measure: Blood chemistry
timeFrame: 28 days
Secondary outcomes:
measure: Product intake
timeFrame: 28 days
measure: Functionality (pain, mobility, strength)
timeFrame: 28 days
measure: Surgical site status
timeFrame: 28 days
Other outcomes:
Locations:
city: Ekaterinburg
country: Russian Federation
facility: Ural State Medical Academy
city: Krasnodar
country: Russian Federation
facility: Regional Clinical Hospital #1
city: Moscow
country: Russian Federation
facility: City Clinical Hospital #15
city: Moscow
country: Russian Federation
facility: City Clinical Hospital #12
city: Moscow
country: Russian Federation
facility: City Clinical Hospital #31
city: Moscow
country: Russian Federation
facility: City Clinical Hospital n.a. Botkina
city: Novosibirsk
country: Russian Federation
facility: State Novosibirsk Regional Hospital
city: Saint Petersburg
country: Russian Federation
facility: Alexandrovskaya City Hospital
city: Saint Petersburg
country: Russian Federation
facility: Saint Petersburg State Medical Academy Mechnikova
city: Samara
country: Russian Federation
facility: Samara Regional Clinical Hospital
city: Ufa
country: Russian Federation
facility: Ufa Medical University, Hospital of Emergency Care
Study officials:
affiliation: Abbott Nutrition
name: Anne C Voss, PhD
role: STUDY_CHAIR
References: