Amino Acid Supplementation in Recovery From Severe Burn

Condition(s) targeted: Burn Injury

Intervention: Dietary Supplement: Amino acids for six weeks (Dietary Supplement); Placebo (Dietary Supplement)

Phase: N/A

Status: Recruiting

Sponsored by: The University of Texas Medical Branch, Galveston

Official(s) and/or principal investigator(s):
Oscar E Suman, PhD, Principal Investigator, Affiliation: UTMB, Shriners Hospitals for Children

Overall contact:
Debra Benjamin, RN, Phone: (409) 772-3622, Email: dbenjam@utmb.edu

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.

Official title: Amino Acid Supplementation in Recovery From Severe Burn

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Primary outcome: Fat metabolism

Secondary outcome:

Muscle protein metabolism

Insulin sensitivity

Minimum age: 7 Years. Maximum age: 17 Years. Gender(s): Both.

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.

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

Shriners Hospitals for Children, Galveston, Texas 77550, United States; Recruiting
Oscar E Suman, PhD, Phone: 409-770-6557, Email: oesuman@utmb.edu
Oscar E Suman, PhD, Principal Investigator

Starting date: May 2012
Last updated: June 30, 2015