Amino Acid Supplementation in Recovery From Traumatic Brain Injury
NCT ID: NCT01495871
Last Updated: 2015-02-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2011-11-30
2014-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
SUPPORTIVE_CARE
TRIPLE
Study Groups
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Amino acids
Amino acid supplementation for 6 weeks
Amino Acids
15 grams amino acids two times per day for 6 weeks
Placebo
Supplementation of placebo (inert components)for 6 weeks
Placebo of inert compounds
Placebo two times per day for 6 weeks
Valine
Valine supplementation for 6 weeks
Valine
2.5 grams valine supplementation two times a day for 6 weeks
Interventions
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Amino Acids
15 grams amino acids two times per day for 6 weeks
Placebo of inert compounds
Placebo two times per day for 6 weeks
Valine
2.5 grams valine supplementation two times a day for 6 weeks
Eligibility Criteria
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Inclusion Criteria
2. Age 18-65 years
3. Ability to sign informed consent
4. \>3 months post-injury, \<36 months post-injury
5. Ambulatory or require minimal to moderate assistance for safe ambulation
Exclusion Criteria
2. Subjects with uncontrolled metabolic disease, including liver or renal disease
3. Subjects with cancer or recently (6 months) treated cancer other than basal cell carcinoma
4. Any subject currently on a weight-loss diet or a body mass index \>34 kg/m2
5. Recent anabolic or corticosteroids use (within 3 months)
6. Dementia
7. Inability to tolerate an upright position
8. Postural reflexes prohibiting ambulation and inability to follow 2-step commands
9. Any other condition or event considered exclusionary by the PIs and covering physician
18 Years
65 Years
ALL
No
Sponsors
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The Moody Foundation
OTHER
The University of Texas Medical Branch, Galveston
OTHER
Responsible Party
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Principal Investigators
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Melinda Sheffield-Moore, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Medical Branch, Galveston
Locations
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Transitional Learning Center
Galveston, Texas, United States
University of Texas Medical Branch
Galveston, Texas, United States
Countries
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Other Identifiers
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10-276
Identifier Type: -
Identifier Source: org_study_id
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