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

NCT01011608 | Completed Phase 3

• 1 other identifier: BK52
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 11

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.

Conditions

Hip Fracture

Outcome Measures

Primary Outcomes (1)

• Blood chemistry

  28 days

Secondary Outcomes (3)

• Product intake

  28 days

• Functionality (pain, mobility, strength)

  28 days

• Surgical site status

  28 days

Study Arms (2)

Medical Food Supplement

EXPERIMENTAL

Medical food supplement to be given in divided portions in morning, afternoon and evening

Other: Medical Food Supplement

standard hospital food

ACTIVE COMPARATOR

standard hospital diet

Other: standard hospital food

Interventions

Medical Food Supplement OTHER

Medical Food Supplement to be given in divided portions in morning, afternoon and evening

Medical Food Supplement

standard hospital food OTHER

standard hospital diet ad. lib.

standard hospital food

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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%.

Sponsors & Collaborators

• Abbott Nutrition: lead

Study Sites (11)

Regional Clinical Hospital #1

Krasnodar, 350086, Russia

Location

City Clinical Hospital #15

Moscow, 111539, Russia

Location

City Clinical Hospital #12

Moscow, 115516, Russia

Location

City Clinical Hospital #31

Moscow, 119415, Russia

Location

City Clinical Hospital n.a. Botkina

Moscow, 125284, Russia

Location

State Novosibirsk Regional Hospital

Novosibirsk, 630087, Russia

Location

Alexandrovskaya City Hospital

Saint Petersburg, 193312, Russia

Location

Saint Petersburg State Medical Academy Mechnikova

Saint Petersburg, Russia

Location

Samara Regional Clinical Hospital

Samara, 443095, Russia

Location

Ufa Medical University, Hospital of Emergency Care

Ufa, 450092, Russia

Location

Ural State Medical Academy

Yekaterinburg, 620007, Russia

Location

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Anne C Voss, PhD

  Abbott Nutrition

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 10, 2009
• First Posted: November 11, 2009
• Study Start: November 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: September 1, 2010
• Last Updated: April 4, 2011

Record last verified: 2010-11

Locations

RU (11)