B-Complex: A Nutraceutical SANS Countermeasure

Part of paid clinical trials in Houston, Texas.

Sponsor
National Aeronautics and Space Administration (NASA)
Study ID
NCT05366933
Phase
PHASE1
Status
Recruiting
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Conditions

  • Endothelial Dysfunction
  • Optic Disc Edema

Eligibility Criteria

Sex
ALL
Age
20 Years - 100 Years
Healthy Volunteers
Accepted

Interventions

  • Vitamin B-Complex Supplement — DRUG
    Vitamin B-Complex Supplement containing: 5-methyltetrahydrofolate, riboflavin 5 phosphate, pyridoxal phosphate, and methylcobalamin

Study Details

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.

Key Dates

Start date
Aug 1, 2022
Status verified
May 2025
Primary completion
Jul 1, 2027
Completion
Sep 30, 2032

Study Design

Enrollment
16 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Supplemented with B-Complex
    Subjects will take a vitamin B-complex supplement before, during, and after a 6-12 month spaceflight on the International Space Station

Primary Outcome Measure

Optic Disc Edema [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johnson Space CenterHoustonTexas77058
Eden Fields

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By research site
Johnson Space Center· Houston, TX

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