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

This study has suspended participant recruitment.
(The VA IRB would not allow demented subjects to be entered in this study.)
Sponsor:
Collaborator:
Abbott
Information provided by:
Central Arkansas Veterans Healthcare System
ClinicalTrials.gov Identifier:
NCT00502372
First received: July 13, 2007
Last updated: May 7, 2010
Last verified: May 2010
  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 1

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:


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:

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

Exclusion Criteria:

  1. Patients with infected wounds
  2. Patients with cellulitis, sepsis or osteomyelitis
  3. Patients with end-organ failure
  4. Patients with poorly controlled diabetes mellitus (HbA1C>10)
  5. Patients who cannot tolerate oral or bolus tube feedings
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Skin Ulcer
Skin Diseases

ClinicalTrials.gov processed this record on October 02, 2014