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

Pressure Ulcers Clinical Trial

Official title:

Nutritional Effect of an Oral Supplement Enriched in Arginine, Glutamine and Leucine Metabolite B-Hydroxy B-Methylbutyrate

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00502372
• Other study ID #: BJ93
• Status: Terminated
• Phase: Phase 1
• First received: July 13, 2007
• Last updated: December 14, 2015
• Start date: December 2008
• Est. completion date: January 2010

Study information

• Verified date: December 2015
• Source: Central Arkansas Veterans Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pressure Ulcer
• Pressure Ulcers

Intervention

Dietary Supplement:
• Nutritional Supplement/Amino acids and HMB
Subjects will be randomized to receive enriched dietary supplement (Juven) v arginine only (Argenaid) dietary supplement
• Juven
comparison of Juven with arginine only product in wound healing

Locations

Country	Name	City	State
United States	Central Arkansas Veterans Healthcare System	Little Rock	Arkansas

Sponsors (2)

Lead Sponsor	Collaborator
Central Arkansas Veterans Healthcare System	Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PUSH tool score	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.	8 weeks or healing completed	No