NCT01477723

Brief Summary

Study objectives are to verify the loss of lean mass during a hospital stay in a group of older patients; to evaluate the effects of consuming a high-calorie complete and balanced oral nutritional supplement; to collect post-discharge information.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2011

Shorter than P25 for phase_3

Geographic Reach
2 countries

14 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 22, 2011

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

February 15, 2013

Status Verified

February 1, 2013

Enrollment Period

1.1 years

First QC Date

November 19, 2011

Last Update Submit

February 14, 2013

Conditions

Pneumonia

Outcome Measures

Primary Outcomes (1)

  • Leg Lean Mass

    baseline to day 30

Secondary Outcomes (3)

  • Body Weight

    baseline to day 30

  • Body Mass Index

    baseline to day 30

  • Activities of daily living

    baseline to day 30

Study Arms (2)

Experimental Oral Nutrition Supplement

EXPERIMENTAL

Experimental ONS orally Two 8 fl oz servings/day

Other: Experimental Oral Nutritional Supplement

No Product

NO INTERVENTION

Interventions

Experimental Oral Nutritional SupplementOTHER

Experimental ONS orally Two 8 fl oz servings/day

Experimental Oral Nutrition Supplement

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 55 years of age.
  • Admitted to hospital with a disease of respiratory system including acute respiratory diseases (e.g., pneumonia, acute bronchitis) or exacerbation of existing respiratory diseases.
  • Anticipated length of hospital stay of at least 3 days.
  • Ability to climb a flight of 10 stairs or walk a city block without the help of another person prior to hospitalization.
  • Able to consume foods and beverages orally.

You may not qualify if:

  • Unstable heart failure which requires ICU admission.
  • Severe respiratory disease requiring long-term, continuous oxygen therapy.
  • Diabetes.
  • Impaired renal function.
  • Impaired liver function.
  • Cancer.
  • Hospitalized for two or more days in past 4 weeks.
  • Requires intubation or tube feeding.
  • Expected to be transferred to an advanced care unit.
  • Body mass index of ≥ 40 kg/m2.
  • Active tuberculosis.
  • Ascites or severe edema.
  • Acute Hepatitis or HIV.
  • Disorder of gastrointestinal tract.
  • Dementia;brain metastases, eating disorder, significant neurological, psychiatric disorder, other psychological condition.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Horizon Research Group Inc

Mobile, Alabama, 36608, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Springfield Clinic

Springfield, Illinois, 62703, United States

Location

Central Maine Medical Center

Lewiston, Maine, 04240, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Mount Carmel West Hospital

Columbus, Ohio, 43222, United States

Location

Medical University of South Carolina (MUSC)

Charleston, South Carolina, 29425, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

The University of Texas Medical Branch

Galveston, Texas, 77555-1144, United States

Location

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location

Salem VA Medical Center

Salem, Virginia, 24153, United States

Location

Hospital HIMA San Pablo

Bayamón, Puerto Rico, 00959, Puerto Rico

Location

Manati Medical Center

Manatí, Puerto Rico, 00647, Puerto Rico

Location

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Vikkie Mustad, 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
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2011

First Posted

November 22, 2011

Study Start

October 1, 2011

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

February 15, 2013

Record last verified: 2013-02

Locations

PR(2)US(12)