NCT05366933 B-Complex: A Nutraceutical SANS Countermeasure
| NCT ID | NCT05366933 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | National Aeronautics and Space Administration (NASA) |
| Condition | Optic Disc Edema |
| Study Type | INTERVENTIONAL |
| Enrollment | 16 participants |
| Start Date | 2022-08-01 |
| Primary Completion | 2027-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 16 participants in total. It began in 2022-08-01 with a primary completion date of 2027-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: • Must be astronauts selected for 6-12 month missions on the International Space Station Exclusion Criteria: • Subjects taking B-vitamin supplements
Contact & Investigator
Sara R Zwart, PhD
PRINCIPAL INVESTIGATOR
UTMB
Frequently Asked Questions
Who can join the NCT05366933 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 100 Years, studying Optic Disc Edema. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05366933 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05366933 currently recruiting?
Yes, NCT05366933 is actively recruiting participants. Contact the research team at sara.zwart-1@nasa.gov for enrollment information.
Where is the NCT05366933 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT05366933 clinical trial?
NCT05366933 is sponsored by National Aeronautics and Space Administration (NASA). The principal investigator is Sara R Zwart, PhD at UTMB. The trial plans to enroll 16 participants.