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

July 13, 2007
May 7, 2010
December 2008
January 2010   (final data collection date for primary outcome measure)
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.
PUSH tool score [ Time Frame: 8 weeks or healing completed ]
Complete list of historical versions of study NCT00502372 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Effect of an Oral Supplement Enriched in Amino Acids and the Leucine Metabolite B-hydroxy B-methylbutyrate (HMB)
Nutritional Effect of an Oral Supplement Enriched in Arginine, Glutamine and Leucine Metabolite B-Hydroxy B-Methylbutyrate

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

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
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Pressure Ulcers
  • 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
  • Experimental: Enriched product, dietary supplement
    Subjects receiving enriched product compared to an unenriched product
    Interventions:
    • Dietary Supplement: Nutritional Supplement/Amino acids and HMB
    • Dietary Supplement: Juven
  • Active Comparator: 1
    Subjects not receiving enriched product
    Interventions:
    • Dietary Supplement: Nutritional Supplement/Amino acids and HMB
    • Dietary Supplement: Juven
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
76
June 2010
January 2010   (final data collection date for primary outcome measure)

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
Both
21 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00502372
BJ93
Yes
Cathey Powers, MD, Central Arkansas Veterans Healthcare System
Central Arkansas Veterans Healthcare System
Abbott
Principal Investigator: Cathey Powers, MD Central Arkansas VA/UAMS College of Medicine
Principal Investigator: Ronni Chernoff, PhD Central Arkansas VA/UAMS College of Medicine
Central Arkansas Veterans Healthcare System
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP