Status:
WITHDRAWN
Amino Acid Supplementation in Recovery From Traumatic Brain Injury
Lead Sponsor:
The University of Texas Medical Branch, Galveston
Collaborating Sponsors:
The Moody Foundation
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Traumatic brain injury (TBI) is a leading cause of death and disability in young people. It has been called the "signature wound" of the Iraq war because of its frequency among troops. TBI is associat...
Eligibility Criteria
Inclusion
- Presence of traumatic brain injury
- Age 18-65 years
- Ability to sign informed consent
- \>3 months post-injury, \<36 months post-injury
- Ambulatory or require minimal to moderate assistance for safe ambulation
Exclusion
- Subjects with cardiac abnormalities considered exclusionary by the study physicians
- Subjects with uncontrolled metabolic disease, including liver or renal disease
- Subjects with cancer or recently (6 months) treated cancer other than basal cell carcinoma
- Any subject currently on a weight-loss diet or a body mass index \>34 kg/m2
- Recent anabolic or corticosteroids use (within 3 months)
- Dementia
- Inability to tolerate an upright position
- Postural reflexes prohibiting ambulation and inability to follow 2-step commands
- Any other condition or event considered exclusionary by the PIs and covering physician
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01495871
Start Date
November 1 2011
End Date
July 1 2014
Last Update
February 11 2015
Active Locations (2)
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1
Transitional Learning Center
Galveston, Texas, United States, 77550
2
University of Texas Medical Branch
Galveston, Texas, United States, 77555