Association of Genetics and B Vitamin Status With the Magnitude of Optic Disc Edema During 30-Day Strict Head-Down Tilt Bed Rest.
Sara R Zwart, Steven S Laurie, John J Chen...
https://pubmed.ncbi.nlm.nih.gov/31415055Actively Recruiting
Led by National Aeronautics and Space Administration (NASA) · Updated on 2025-05-22
16
Participants Needed
1
Research Sites
274 weeks
Total Duration
N
National Aeronautics and Space Administration (NASA)
Lead Sponsor
M
Mayo Clinic
Collaborating Sponsor
Researchers are evaluating a daily nutraceutical supplement containing bioactive B vitamins to reduce optic disc edema in astronauts during long-duration space missions. This study focuses on optimizing the one-carbon metabolic pathway to improve enzyme function, enhance blood vessel health, strengthen eye tissue elasticity, and reduce retinal thickness changes. The investigation aims to better understand causes of optic disc edema and the effects of this nutritional countermeasure compared to astronauts who did not use supplements. Participants will take a vitamin B-complex supplement before, during, and after a 6 to 12 month spaceflight on the International Space Station. This supplement includes 5-methyltetrahydrofolate, riboflavin 5 phosphate, pyridoxal phosphate, and methylcobalamin. Blood samples are collected multiple times before, during, and after flight to assess vitamin levels, biochemistry, and genetic markers. Eye scans using optical coherence tomography and blood flow measurements will monitor ocular and vascular health. Throughout the study, participants will undergo various tests including blood draws, skin scans for advanced glycation end products, and fingertip temperature assessments to evaluate vascular function. Dietary intake, exercise logs, and medication use will be reviewed. The main outcome is measuring optic disc edema over six months, along with secondary measures of endothelial function, vitamin statuses, oxidative stress markers, and other biochemical indicators. The study lasts throughout the flight and follow-up periods to monitor ongoing effects.
CONDITIONS
B-Complex: A Nutraceutical SANS Countermeasure
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 6 to 12 months
Participants take a vitamin B-complex supplement before, during, and after their spaceflight mission on the International Space Station lasting 6 to 12 months.
Visits for blood sample collection and assessments occur approximately 180 days and 45 days before flight, on flight day 90, 30 days before landing, 0 to 2 days after return to Earth, and 30 days after landing.
Total: 1 location
1
Johnson Space Center
Houston, Texas, United States, 77058
Actively Recruiting
S
Sara Zwart, PhD
E
Eden Fields
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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