B-Complex: A Nutraceutical SANS Countermeasure

NCT05366933 | Recruiting Phase 1 FDA Drug

• 1 other identifier: NASA IRB STUDY00000448
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Optic Disc Edema

  Measure change in total retinal thickness during and after flight compared to preflight using OCT

  6 months

Secondary Outcomes (26)

• Endothelial function

  6 months

• Advanced Glycation End Products (AGE)

  6 months

• Serum folate status

  6 months

• Red Blood Cell folate status

  6 months

• Vitamin B6 status

  6 months

Study Arms (1)

Supplemented with B-Complex

EXPERIMENTAL

Subjects will take a vitamin B-complex supplement before, during, and after a 6-12 month spaceflight on the International Space Station

Drug: Vitamin B-Complex Supplement

Interventions

Vitamin B-Complex Supplement DRUG

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

Supplemented with B-Complex

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Subjects taking B-vitamin supplements

Sponsors & Collaborators

• National Aeronautics and Space Administration (NASA): lead
• Mayo Clinic: collaborator
• Texas A&M University: collaborator

Study Sites (1)

Johnson Space Center

Houston, Texas, 77058, United States

RECRUITING

Related Publications (5)

• Zwart SR, Laurie SS, Chen JJ, Macias BR, Lee SMC, Stenger M, Grantham B, Carey K, Young M, Smith SM. Association of Genetics and B Vitamin Status With the Magnitude of Optic Disc Edema During 30-Day Strict Head-Down Tilt Bed Rest. JAMA Ophthalmol. 2019 Oct 1;137(10):1195-1200. doi: 10.1001/jamaophthalmol.2019.3124.

  PMID: 31415055 BACKGROUND

• Zwart SR, Gibson CR, Gregory JF, Mader TH, Stover PJ, Zeisel SH, Smith SM. Astronaut ophthalmic syndrome. FASEB J. 2017 Sep;31(9):3746-3756. doi: 10.1096/fj.201700294. Epub 2017 May 25.

  PMID: 28546443 BACKGROUND

• Smith SM, Zwart SR. Spaceflight-related ocular changes: the potential role of genetics, and the potential of B vitamins as a countermeasure. Curr Opin Clin Nutr Metab Care. 2018 Nov;21(6):481-488. doi: 10.1097/MCO.0000000000000510.

  PMID: 30169456 BACKGROUND

• McGregor HR, Lee JK, Mulder ER, De Dios YE, Beltran NE, Kofman IS, Bloomberg JJ, Mulavara AP, Smith SM, Zwart SR, Seidler RD. Ophthalmic changes in a spaceflight analog are associated with brain functional reorganization. Hum Brain Mapp. 2021 Sep;42(13):4281-4297. doi: 10.1002/hbm.25546. Epub 2021 Jun 9.

  PMID: 34105833 BACKGROUND

• Laurie SS, Vizzeri G, Taibbi G, Ferguson CR, Hu X, Lee SMC, Ploutz-Snyder R, Smith SM, Zwart SR, Stenger MB. Effects of short-term mild hypercapnia during head-down tilt on intracranial pressure and ocular structures in healthy human subjects. Physiol Rep. 2017 Jun;5(11):e13302. doi: 10.14814/phy2.13302.

  PMID: 28611153 BACKGROUND

MeSH Terms

Conditions

Papilledema

Condition Hierarchy (Ancestors)

Optic Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases

Study Officials

• Sara R Zwart, PhD

  UTMB

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Zwart, PhD

CONTACT

2814833753; sara.zwart-1@nasa.gov

Eden Fields

CONTACT

2814837864; eden.e.fields@nasa.gov

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Manager for Nutritional Biochemistry

Study Record Dates

• First Submitted: April 29, 2022
• First Posted: May 9, 2022
• Study Start: August 1, 2022
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): September 30, 2032
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)