Amino Acid Supplementation in Recovery From Severe Burn (ExAA)
This study is currently recruiting participants.
Verified June 2012 by The University of Texas, Galveston
Sponsor:
The University of Texas, Galveston
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 11, 2012
Last verified: June 2012
| Tracking Information | |||||
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| First Received Date ICMJE | May 30, 2012 | ||||
| Last Updated Date | June 11, 2012 | ||||
| Start Date ICMJE | May 2012 | ||||
| Estimated Primary Completion Date | October 2016 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01618630 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Amino Acid Supplementation in Recovery From Severe Burn | ||||
| Official Title ICMJE | Amino Acid Supplementation in Recovery From Severe Burn | ||||
| Brief Summary | 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Basic Science |
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| Condition ICMJE | Burn Injury | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 40 | ||||
| Estimated Completion Date | December 2016 | ||||
| Estimated Primary Completion Date | October 2016 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 7 Years to 17 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01618630 | ||||
| Other Study ID Numbers ICMJE | 12-048 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | The University of Texas, Galveston | ||||
| Study Sponsor ICMJE | The University of Texas, Galveston | ||||
| Collaborators ICMJE | Shriners Hospitals for Children | ||||
| Investigators ICMJE |
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| Information Provided By | The University of Texas, Galveston | ||||
| Verification Date | June 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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