Amino Acid Supplementation in Recovery From Severe Burn (ExAA)

This study is currently recruiting participants.
Verified June 2013 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 20, 2013
Last verified: June 2013

May 30, 2012
June 20, 2013
May 2012
October 2016   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01618630 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Amino Acid Supplementation in Recovery From Severe Burn
Amino Acid Supplementation in Recovery From Severe Burn

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Burn Injury
  • Dietary Supplement: Dietary Supplement: Amino acids for six weeks
    Amino acids in drinks between meals for six weeks.
  • Dietary Supplement: Placebo
    Placebo supplementation as drinks in between meals for six weeks
  • Active Comparator: Amino acids
    Amino acid supplementation for six weeks
    Intervention: Dietary Supplement: Dietary Supplement: Amino acids for six weeks
  • Placebo Comparator: Placebo
    Supplementation of placebo (inert components) for six weeks
    Intervention: Dietary Supplement: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
December 2016
October 2016   (final data collection date for primary outcome measure)

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.
Both
7 Years to 17 Years
No
Contact: Debra Benjamin, RN (409) 772-3622 dbenjam@utmb.edu
United States
 
NCT01618630
12-048
Yes
The University of Texas, Galveston
The University of Texas, Galveston
Shriners Hospitals for Children
Principal Investigator: Elisabet Borsheim, PhD UTMB, Shriners Hospitals for Children
The University of Texas, Galveston
June 2013

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