Recruiting
Phase 1

Bioactive B Vitamins

Sponsor:

National Aeronautics and Space Administration (NASA)

Code:

NCT05366933

Conditions

Optic Disc Edema

Endothelial Dysfunction

Eligibility Criteria

Sex: All

Age: 20 - 70+

Healthy Volunteers: Accepted

Interventions

Vitamin B-Complex Supplement

Study Details

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.

Conditions

Optic Disc Edema

Endothelial Dysfunction

Study ID

NCT05366933

Start date

Aug 1, 2022

Status verified date

Nov, 2026

Completion date

Sep 30, 2035

Anticipated

Primary completion date

Jul 1, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

• Must be astronauts selected for 6-12 month missions on the International Space Station

Exclusion Criteria:

• Subjects taking B-vitamin supplements

Study Design

Enrollment

16 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

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

Interventions

Vitamin B-Complex Supplement

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

Primary outcome measure

  • Optic Disc Edema [ Time Frame: 6 months ]

Central Contacts and Locations

Locations

Johnson Space Center

Recruiting

Houston, Texas, United States, 77058

More Information

Sponsor

National Aeronautics and Space Administration (NASA)

Last update posted

Nov 12, 2026

Last verified

Nov, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-13. This information was provided to ClinicalTrials.gov by National Aeronautics and Space Administration (NASA) on 2026-11-12. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.