Effect of an Oral Supplement Enriched in Amino Acids and the Leucine Metabolite B-hydroxy B-methylbutyrate (HMB) - Full Text View

Sponsor:	Central Arkansas Veterans Healthcare System
Collaborator:	Abbott
Information provided by:	Central Arkansas Veterans Healthcare System
ClinicalTrials.gov Identifier:	NCT00502372

Purpose

The focus of this study is to look at the role of nutrition in the healing of pressure ulcers. The purpose of this study is to test whether the rate of healing of pressure ulcers is increased in those patients receiving a nutritional supplement of amino acids and the leucine metabolite, B-hydroxy-B-methylbutyrate is enhanced when compared to control patients receiving a supplement containing only one of the proteins in the experimental supplement

Condition	Intervention	Phase
Pressure Ulcers	Dietary Supplement: Nutritional Supplement/Amino acids and HMB Dietary Supplement: Juven	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Nutritional Effect of an Oral Supplement Enriched in Arginine, Glutamine and Leucine Metabolite B-Hydroxy B-Methylbutyrate

Resource links provided by NLM:

MedlinePlus related topics: Dietary Supplements Pressure Sores

Drug Information available for: Leucine Arginine Amino acids, branched-chain

U.S. FDA Resources

Further study details as provided by Central Arkansas Veterans Healthcare System:

Primary Outcome Measures:

PUSH tool score [ Time Frame: 8 weeks or healing completed ] [ Designated as safety issue: No ]
The PUSH tool measures the healing of a pressure ulcer by actually measuring the depth and width, in 2 dimensions, of a wound. A wound heals from the wound bed and closes from the inside to the outside if healthy pink granulation tissue can be seen. This tool contributes to the consistency of measurement of a healing wound.

Estimated Enrollment:	76
Study Start Date:	December 2008
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Enriched product, dietary supplement Subjects receiving enriched product compared to an unenriched product	Dietary Supplement: Nutritional Supplement/Amino acids and HMB Subjects will be randomized to receive enriched dietary supplement (Juven) v arginine only (Argenaid) dietary supplement Other Names: Juven Argenaid Dietary Supplement: Juven comparison of Juven with arginine only product in wound healing Other Names: Juven Argenaid
Active Comparator: 1 Subjects not receiving enriched product	Dietary Supplement: Nutritional Supplement/Amino acids and HMB Subjects will be randomized to receive enriched dietary supplement (Juven) v arginine only (Argenaid) dietary supplement Other Names: Juven Argenaid Dietary Supplement: Juven comparison of Juven with arginine only product in wound healing Other Names: Juven Argenaid

Detailed Description:

Patients who have pressure ulcers Stage II or greater will be randomized to receiving one of two nutritional supplements. One supplement contains arginine and the other contains both arginine,glutamine and leucine metabolites. Pressure ulcers will be measured at study entry and measured biweekly using a standardized tool (PUSH) until the trial is completed or the pressure ulcer has healed.

Inclusion criteria include:

Stage II or greater pressure ulcer
Patient consent
Patients who can drink supplement or receive it by tube
Patients who are 21 years old or greater

Exclusion criteria include:

Patients with infected wounds
Patients with cellulitis, sepsis or osteomyelitis
Patients with end-organ failure
Patients with poorly controlled diabetes mellitus (HbA1C>10)
Patients who cannot tolerate oral or tube feeding

Eligibility

Ages Eligible for Study:	21 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with Stage II pressure ulcer or greater
Patients who consent to participate
Patients who can ingest the supplement either orally or per feeding tube
Patients who are 21 years of age or older

Exclusion Criteria:

Patients with infected wounds
Patients with cellulitis, sepsis or osteomyelitis
Patients with end-organ failure
Patients with poorly controlled diabetes mellitus (HbA1C>10)
Patients who cannot tolerate oral or bolus tube feedings

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00502372

Locations

United States, Arkansas
Central Arkansas Veterans Healthcare System
Little Rock, Arkansas, United States, 72205

Sponsors and Collaborators

Central Arkansas Veterans Healthcare System

Abbott

Investigators

Principal Investigator:	Cathey Powers, MD	Central Arkansas VA/UAMS College of Medicine
Principal Investigator:	Ronni Chernoff, PhD	Central Arkansas VA/UAMS College of Medicine

More Information

No publications provided

Responsible Party:	Cathey Powers, MD, Central Arkansas Veterans Healthcare System
ClinicalTrials.gov Identifier:	NCT00502372 History of Changes
Other Study ID Numbers:	BJ93
Study First Received:	July 13, 2007
Last Updated:	May 7, 2010
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Pressure Ulcer
Ulcer
Skin Ulcer
Skin Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on February 09, 2012