Amino Acid Supplementation in Recovery From Severe Burn (ExAA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by The University of Texas, Galveston
Sponsor:
Collaborator:
Shriners Hospitals for Children
Information provided by (Responsible Party):
The University of Texas, Galveston
ClinicalTrials.gov Identifier:
NCT01618630
First received: May 30, 2012
Last updated: June 5, 2014
Last verified: June 2014
  Purpose

Severe burns result in persistent and extensive fat deposition in liver and muscle tissue. This may be related to the prolonged insulin resistance observed following burn. In this study the investigators will test the hypothesis that essential amino acids act in synergy with exercise to improve liver steatosis and muscle lipid metabolism, and thus also affect insulin sensitivity. Children with burns will participate in six weeks of exercise training with/without amino acid supplementation. Before and after the intervention, measurements will be done to determine muscle and liver fat content, muscle fat and protein metabolism, and insulin sensitivity.


Condition Intervention
Burn Injury
Dietary Supplement: Dietary Supplement: Amino acids for six weeks
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Amino Acid Supplementation in Recovery From Severe Burn

Resource links provided by NLM:


Further study details as provided by The University of Texas, Galveston:

Primary Outcome Measures:
  • Fat metabolism [ Time Frame: 6 weeks of intervention (study visits at beginning and end of 6 weeks of supplementation and +/- exercise) ] [ Designated as safety issue: No ]
    Lipid levels, fat oxidation


Secondary Outcome Measures:
  • Muscle protein metabolism [ Time Frame: 6 weeks of intervention (study visits at beginning and end of 6 weeks of supplementation and +/- exercise) ] [ Designated as safety issue: No ]
    Muscle protein synthesis and breakdown

  • Insulin sensitivity [ Time Frame: 6 weeks of intervention (study visits at beginning and end of 6 weeks of supplementation and +/- exercise) ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: May 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Amino acids
Amino acid supplementation for six weeks
Dietary Supplement: Dietary Supplement: Amino acids for six weeks
Amino acids in drinks between meals for six weeks.
Placebo Comparator: Placebo
Supplementation of placebo (inert components) for six weeks
Dietary Supplement: Placebo
Placebo supplementation as drinks in between meals for six weeks

  Eligibility

Ages Eligible for Study:   7 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female
  2. 7-17 years old
  3. Body weight >20 kg (based on blood requirements)
  4. ≥30% Total Body Surface Area (TBSA)
  5. Wounds 95% healed

Exclusion Criteria:

  1. Respiratory insufficiency
  2. Multiple fractures
  3. History of Cancer in the last 5 years
  4. Diabetes Mellitus
  5. Bilirubin > 3 mg/dl
  6. Associated head injuries requiring specific therapy
  7. Associated injuries to chest or abdomen requiring surgery
  8. Serum creatinine > 3 mg/dl after fluid resuscitation
  9. Receipt of any experimental drug other than the ones supplied within two months of this study
  10. Any metal in body including rods, neurofibrillators, pacemakers, etc
  11. Orthopedic casting which would prevent placement of patient in MRI machine
  12. Hepatitis
  13. Abnormal EKG
  14. Electrical burns
  15. Patients unable to lie still without heavy sedation will be excluded from MRI portion.
  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: NCT01618630

Contacts
Contact: Debra Benjamin, RN (409) 772-3622 dbenjam@utmb.edu

Locations
United States, Texas
Shriners Hospitals for Children Recruiting
Galveston, Texas, United States, 77550
Contact: Elisabet Borsheim, PhD    409-770-6609    elborshe@utmb.edu   
Principal Investigator: Elisabet Borsheim, PhD         
Sponsors and Collaborators
The University of Texas, Galveston
Shriners Hospitals for Children
Investigators
Principal Investigator: Elisabet Borsheim, PhD UTMB, Shriners Hospitals for Children
  More Information

No publications provided

Responsible Party: The University of Texas, Galveston
ClinicalTrials.gov Identifier: NCT01618630     History of Changes
Other Study ID Numbers: 12-048
Study First Received: May 30, 2012
Last Updated: June 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas, Galveston:
burn injury
children
nutrition
lipid metabolism
insulin sensitivity
amino acids
stable isotopes

Additional relevant MeSH terms:
Burns
Wounds and Injuries

ClinicalTrials.gov processed this record on October 20, 2014