Amino Acid Supplementation in Recovery From Severe Burns

NCT01618630 | Completed DMC

• 1 other identifier: 12-048
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Exercise during recovery is now Standard of Care at Shriners Hospital for Children Galveston, since positive effects of exercise training were found on lean body mass and recovery after burns. Essential amino acids (EAA) effective in healthy individuals.Thus, EAA supplementation in children recovering from burns, may potentially augment the effects of exercise by increase muscle mass, improve muscle fat oxidation, reduce tissue fat, and possibly improve insulin resistance.

Conditions

Burn Injury

Keywords

burn injury; children; nutrition; lipid metabolism; insulin sensitivity; amino acids

Outcome Measures

Primary Outcomes (1)

• Lean Muscle Mass

  Is the total weight of your body minus all the weight due to your fat mass. It is measured in kilograms by dual X-ray absorptiometry scan.

  It is the change in time, from baseline until post exercise. Baseline is within the first week of discharge from the burn ICU, approximately 1-3 months post burn. Exercise training is 6-12 weeks.

Secondary Outcomes (2)

• whole body lipolysis rate

  It is the change in time, from baseline until post exercise. Baseline is within the first week of discharge from the burn ICU, approximately 1-3 months post burn. Exercise training is 6-12 weeks.

• Hepatic glucose release rate and whole body glucose uptake rate

  It is the change in time, from baseline until post exercise. Baseline is within the first week of discharge from the burn ICU, approximately 1-3 months post burn. Exercise training is 6-12 weeks.

Study Arms (2)

EAA Supplementation + Exercise Training

EXPERIMENTAL

Drink an amino acid supplementation during exercise training.

Dietary Supplement: EAA Supplementation + Exercise Training

Placebo + Exercise Training

PLACEBO COMPARATOR

Drink a placebo supplementation during exercise training.

Dietary Supplement: Placebo + Exercise Training

Interventions

EAA Supplementation + Exercise Training DIETARY_SUPPLEMENT

Amino acids in drinks between meals for exercise training period.

EAA Supplementation + Exercise Training

Placebo + Exercise Training DIETARY_SUPPLEMENT

Placebo supplementation as drinks in between meals for exercise training period.

Placebo + Exercise Training

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male or female
• years old
• Body weight \>20 kg (based on blood requirements)
• ≥30% Total Body Surface Area (TBSA)
• Wounds 95% healed

You may not qualify if:

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

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead
• Shriners Hospitals for Children: collaborator

Study Sites (1)

Shriners Hospitals for Children

Galveston, Texas, 77550, United States

Location

MeSH Terms

Conditions

Burns; Insulin Resistance

Interventions

Exercise

Condition Hierarchy (Ancestors)

Wounds and Injuries; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Oscar E Suman, PhD

  UTMB, Shriners Hospitals for Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2012
• First Posted: June 13, 2012
• Study Start: May 1, 2012
• Primary Completion: December 5, 2016
• Study Completion: December 5, 2017
• Last Updated: December 11, 2018

Record last verified: 2018-11

Locations

US (1)