B-Complex: A Nutraceutical SANS Countermeasure
National Aeronautics and Space Administration (NASA) · with Mayo Clinic, Texas A&M University · NCT05366933
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 20–100 · All sexes
- Healthy volunteers
- Accepted
- Study type
- Interventional · Phase 1
- Target enrollment
- 16
- US sites recruiting
- 1
- Study start
- August 1, 2022
- Record last updated
- May 22, 2025
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: Vitamin B-Complex Supplement
Conditions: Optic Disc Edema; Endothelial Dysfunction
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- Must be astronauts selected for 6-12 month missions on the International Space Station
Exclusion Criteria
- Subjects taking B-vitamin supplements
Recruiting US locations
Johnson Space Center
Houston, TX 77058
Site contact: Eden Fields
Study contacts (from the official record)
- Sara Zwart, PhD · 2814833753 · sara.zwart-1@nasa.gov
- Eden Fields · 2814837864 · eden.e.fields@nasa.gov
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