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NCT04603443 · ClinicalTrials.gov registry record · NA
SmART-TBI: Supplementation With Amino Acid Rehabilitative Therapy in TBI
A NA study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- NA
- Development phase
- 160
- Enrollment target
NCT04603443: Completed NA study, sponsored by VA Office of Research and Development.
NCT04603443 is a NA study that has completed, run by VA Office of Research and Development. The registered enrollment target is 160 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04603443, a NA study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- NA
- Development phase
- 160 participants
- Enrollment target
Study Summary
The most persistent and disabling postconcussive symptoms following mild traumatic brain injury (mTBI) are sleep disturbances and cognitive dysfunction, with few tractable interventions currently available. Here, a novel therapy will be tested consisting of dietary supplementation with branched chain amino acids (BCAA), based on the study team's previous preclinical work showing restoration of glutamate neurotransmitter balance in sleep and memory circuits. Supplementation with Amino acid Rehabilitative Therapy in TBI (SmART-TBI) is a randomized, placebo-controlled, double-blinded, exploratory clinical trial of BCAA intended to establish the feasibility, acceptability, and limited efficacy of long-term BCAA to improve sleep and cognition in Veterans with mTBI. These results will inform the optimal study design of a future, full-scale randomized controlled trial, including the identification of the proper dose and duration of BCAA to improve sleep and the potential subpopulations of Veterans with mTBI that may benefit the most.
Interventions
- DIETARY_SUPPLEMENT Branched Chain Amino Acids
- DIETARY_SUPPLEMENT Protein Control
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2021-06-01 |
| Est. Completion | 2025-09-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04603443
The ClinicalTrials.gov registry entry for NCT04603443 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 160 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Branched Chain Amino Acids is the first listed.
NCT04603443 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04603443 about?
NCT04603443 is a clinical study titled "SmART-TBI: Supplementation With Amino Acid Rehabilitative Therapy in TBI". The most persistent and disabling postconcussive symptoms following mild traumatic brain injury (mTBI) are sleep disturbances and cognitive dysfunction, with few tractable interventions currently available. Here, a novel therapy will be tested consisting of dietary supplementation with branched chai...
What is the current status of trial NCT04603443?
This trial is currently completed. It is a NA study. The enrollment target is 160 participants. The study started on 2021-06-01. Estimated completion is 2025-09-30.
What interventions are being tested in trial NCT04603443?
The interventions under investigation include: Branched Chain Amino Acids (DIETARY_SUPPLEMENT), Protein Control (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT04603443?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
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