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NCT05366933 · ClinicalTrials.gov registry record · Phase 1
B-Complex: A Nutraceutical SANS Countermeasure
A Phase 1 study of Endothelial Dysfunction and Optic Disc Edema, sponsored by National Aeronautics and Space Administration (NASA).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT05366933: Recruiting Phase 1 study of Endothelial Dysfunction and Optic Disc Edema, sponsored by National Aeronautics and Space Administration (NASA).
NCT05366933 is a Phase 1 study of Endothelial Dysfunction and Optic Disc Edema that is actively recruiting participants, run by National Aeronautics and Space Administration (NASA). The registered enrollment target is 16 participants, below the 92-participant average among 45 other Endothelial Dysfunction trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05366933, a Phase 1 study of Endothelial Dysfunction and Optic Disc Edema, is actively recruiting participants, sponsored by National Aeronautics and Space Administration (NASA).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study Summary
In this project, the investigators propose to test effectiveness of a daily nutraceutical supplement containing bioactive B vitamins to mitigate optic disc edema in astronauts. The proposed countermeasure is intended to maximize functioning of the one-carbon metabolic pathway to provide enough substrate and cofactors to overcome any genetic differences that may impact the efficiency of enzyme function. By optimizing the pathway, this will 1) optimize endothelial function by increasing eNOS coupling and nitric oxide synthesis and 2) optimize collagen firmness and elasticity in the sclera and lamina cribrosa, and 3) minimize changes in total retinal thickness during and after flight. The protocol includes assessments of ocular health and function, along with determinants of vascular endothelial function, advanced glycation end products, and nutritional status and one carbon biochemistry. These additional measures will be critical for the further definition of the causes of optic disc edema in some astronauts after long-duration space flight, and in understanding the effect of the countermeasure. Finally, the supplemented subjects in this study will be compared against total retinal thickness data from previously flown astronauts known to have not taken supplements during their missions.
Primary Outcome
Measure change in total retinal thickness during and after flight compared to preflight using OCT
Conditions Studied
Interventions
- DRUG Vitamin B-Complex Supplement
Study Locations (1)
Texas
- Johnson Space Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2022-08-01 |
| Est. Completion | 2032-09-30 |
| Phase | Phase 1 |
What NCT05366933 shows while recruiting
NCT05366933 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 92-participant average among 45 other Endothelial Dysfunction trials with a reported enrollment target (83% lower).
The record links to 2 conditions, with Endothelial Dysfunction appearing as the primary indexed condition, and to 1 intervention - of which Vitamin B-Complex Supplement is the first listed.
NCT05366933 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT05366933 about?
NCT05366933 is a clinical study titled "B-Complex: A Nutraceutical SANS Countermeasure". In this project, the investigators propose to test effectiveness of a daily nutraceutical supplement containing bioactive B vitamins to mitigate optic disc edema in astronauts. The proposed countermeasure is intended to maximize functioning of the one-carbon metabolic pathway to provide enough subst...
What is the current status of trial NCT05366933?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2022-08-01. Estimated completion is 2032-09-30.
What conditions does trial NCT05366933 study?
This clinical trial studies the following conditions: Endothelial Dysfunction, Optic Disc Edema.
What interventions are being tested in trial NCT05366933?
The interventions under investigation include: Vitamin B-Complex Supplement (DRUG).
Who is sponsoring clinical trial NCT05366933?
This trial is sponsored by National Aeronautics and Space Administration (NASA), which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05366933 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05366933's enrollment target sits among peer trials
16 44th of 45 higher than 2 of 45 other Endothelial Dysfunction trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Endothelial Dysfunction trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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