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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

127 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Hip Fracture Surgery and Oral Nutritional Supplements

NCT01505985

Hip Fracture

TERMINATED PHASE3

Nutritional Intervention and Outcomes in Elderly After Hip Fracture Surgery

NCT04451538

Elderly Patients Malnutrition Hip Fractures +3 more

TERMINATED NA

Nutritional Supplementation in Geriatric Hip Fractures

NCT06773000

Geriatric Hip Fracture

RECRUITING NA

Impact of a Nutritional Supplement on the Recovery of the Nutritional Status of Patients With Spontaneous Hip Fracture

NCT04183075

Hip Fractures Malnutrition

UNKNOWN NA

Improving Functional Recovery After Hip Fracture

NCT00000436

Unilateral Hip Fracture

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hip Fracture

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Medical Food Supplement

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

Group Type EXPERIMENTAL

Medical Food Supplement

Intervention Type OTHER

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

standard hospital food

standard hospital diet

Group Type ACTIVE_COMPARATOR

standard hospital food

Intervention Type OTHER

standard hospital diet ad. lib.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Medical Food Supplement

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

Intervention Type OTHER

standard hospital food

standard hospital diet ad. lib.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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%.

Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No