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

Hip Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01011608
• Other study ID #: BK52
• Status: Completed
• Phase: Phase 3
• First received: November 10, 2009
• Last updated: April 1, 2011
• Start date: November 2009
• Est. completion date: September 2010

Study information

• Verified date: November 2010
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: September 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years and older

Eligibility

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%.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hip Fracture
• Hip Fractures

Intervention

Other:
• Medical Food Supplement
Medical Food Supplement to be given in divided portions in morning, afternoon and evening
• standard hospital food
standard hospital diet ad. lib.

Locations

Country	Name	City	State
Russian Federation	Ural State Medical Academy	Ekaterinburg
Russian Federation	Regional Clinical Hospital #1	Krasnodar
Russian Federation	City Clinical Hospital #12	Moscow
Russian Federation	City Clinical Hospital #15	Moscow
Russian Federation	City Clinical Hospital #31	Moscow
Russian Federation	City Clinical Hospital n.a. Botkina	Moscow
Russian Federation	State Novosibirsk Regional Hospital	Novosibirsk
Russian Federation	Alexandrovskaya City Hospital	Saint Petersburg
Russian Federation	Saint Petersburg State Medical Academy Mechnikova	Saint Petersburg
Russian Federation	Samara Regional Clinical Hospital	Samara
Russian Federation	Ufa Medical University, Hospital of Emergency Care	Ufa

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Nutrition

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood chemistry		28 days	No
Secondary	Product intake		28 days	No
Secondary	Functionality (pain, mobility, strength)		28 days	No
Secondary	Surgical site status		28 days	No