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Optic Disc EdemaPhase 1NCT05366933

B-Complex: A Nutraceutical SANS Countermeasure

A Phase 1 study testing Vitamin B-Complex Supplement in people with Optic Disc Edema and Endothelial Dysfunction, run by National Aeronautics and Space Administration (NASA) at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 20 to 100 yearsHealthy volunteers can take part
Conditions the study is for
Optic Disc Edema, Endothelial Dysfunction
What is being tested?
Vitamin B-Complex Supplement
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteUnited States
Study dates
1 Aug 2022to 30 Sep 2032
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 100 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Subjects taking B-vitamin supplements

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sara Zwart, PhD contact

2814833753

sara.zwart-1@nasa.gov

Eden Fields contact

2814837864

eden.e.fields@nasa.gov

United States1 site, 1 recruiting

  • Johnson Space Center

    Houston, Texas, 77058

    Eden Fields

    Recruiting

Other trials in United States

About this study

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.

Read the detailed description

Fasting (8-h) blood samples (7.5 mL SST and 5 mL EDTA tubes, 12.5 mL total per session) will be collected approximately 180 days and 45 days before flight, on approximate flight day 90, and 30 days before landing, Return to Earth +0-2 days and 30 days after landing.

Blood samples will be analyzed for vitamin status and one-carbon biochemistry, as previously described. One blood sample (collected before flight) will be analyzed for approximately 511 SNPs matching the profile of testing from our ongoing research related to optic disc edema. Serum samples will be analyzed for biochemistry measures evaluating endothelial function, vitamin status, and oxidative damage.

Nutritional status assessment data, including inflight dietary intake and body mass data, completed for routine medical requirements will be requested for data sharing. Inflight medical exercise log data as well as available standard measures data will also be requested for data sharing. Medication use/Med Logs will also be requested for data sharing.

Vascular function VENDYS-II (Endothelix, Inc) will be used to assess reactive hyperaemia through changes in fingertip temperature. The test consists of an automated blood pressure measurement followed by cuff occlusion of the right arm for 2 to 5 min. During this time, the fingertip temperature in the right hand decreases because of the lack of circulation in the fingertip. After the cuff is released, blood flow resumes, causing a temperature rebound in the fingertip in a manner that is proportional to vascular reactivity.

Advanced Glycation End (AGE) Products Skin autofluorescence (SAF) will be analyzed non-invasively using an AGE reader (Diagnoptics Technologies, Groningen, the Netherlands). The AGE reader illuminates a skin surface of approximately 4 cm2, guarded against surrounding light, with an excitation light source with wavelength between 300 and 429 nm. This method is based on the fluorescent properties of certain AGEs accumulated in dermal tissue.

OCT and OCT-A Optical coherence tomography (OCT) and OCT-angiography (OCT-A) scans will be acquired using the Spectralis OCT2 (Heidelberg Engineering) before, during, and after flight. The scan pattern includes 24 B-scans centered in a radial pattern over the optic nerve head, as well as a 3.5 mm circle scan surrounding the optic nerve head for assessment of retinal nerve fiber layer thickness and choroid thickness. For OCT-A, five consecutive volume scans will be obtained in these regions, each containing 216 A-scans. These images will be registered, and the consecutive B-scans will be used to calculate the decorrelation among the images to provide split-spectrum amplitude decorrelation angiography (SSADA) images. This decorrelation between consecutive B-scan images will be used to highlight locations where there is blood flow. The density of the perfused peripapillary vessels within the various layers of the retina will be calculated to create a flow density map.

Being tested
Vitamin B-Complex Supplement
Medical subject headings
Papilledema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vitamin B-Complex SupplementDrug

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

Study groups in NCT05366933
Study groupRoleWhat they receive
Supplemented with B-ComplexExperimentalSubjects will take a vitamin B-complex supplement before, during, and after a 6-12 month spaceflight on the International Space Station
Receives: Drug: Vitamin B-Complex Supplement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Optic Disc Edema

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

    Measured: 6 months

Secondary outcomes (26)

  1. Endothelial function

    Assess reactive hyperemia through changes in fingertip temperature

    Measured: 6 months

  2. Advanced Glycation End Products (AGE)

    Skin autofluorescence (SAF) will be analyzed non-invasively using an AGE reader

    Measured: 6 months

  3. Serum folate status

    Vitamin status assessed from a fasting blood sample

    Measured: 6 months

  4. Red Blood Cell folate status

    Vitamin status assessed from a fasting blood sample

    Measured: 6 months

  5. Vitamin B6 status

    Vitamin status assessed from a fasting blood sample

    Measured: 6 months

  6. Vitamin B12 status

    Vitamin status assessed from a fasting blood sample

    Measured: 6 months

  7. Glucose

    Serum glucose from a fasting blood sample

    Measured: 6 months

  8. Nitric oxide

    Serum nitric oxide from a fasting blood sample

    Measured: 6 months

  9. tetrahydrobiopterin

    Serum biochemistry from a fasting blood sample

    Measured: 6 months

  10. Dihydrobiopterin

    Serum biochemistry from a fasting blood sample

    Measured: 6 months

  11. Oxidized glutathione

    Serum biochemistry from a fasting blood sample

    Measured: 6 months

  12. Total antioxidant capacity

    Serum biochemistry from a fasting blood sample

    Measured: 6 months

  13. Advanced glycation end products

    Serum biochemistry from a fasting blood sample

    Measured: 6 months

  14. Albumin

    Serum biochemistry from a fasting blood sample

    Measured: 6 months

  15. Glycated albumin

    Serum biochemistry from a fasting blood sample

    Measured: 6 months

  16. 3-nitrotyrosine

    Serum biochemistry from a fasting blood sample

    Measured: 6 months

  17. Formate

    Serum biochemistry from a fasting blood sample

    Measured: 6 months

  18. MMP-2

    Serum biochemistry from a fasting blood sample

    Measured: 6 months

  19. MMP-9

    Serum biochemistry from a fasting blood sample

    Measured: 6 months

  20. TIMP-1

    Serum biochemistry from a fasting blood sample

    Measured: 6 months

  21. TIMP-2

    Serum biochemistry from a fasting blood sample

    Measured: 6 months

  22. Heparan sulfate

    Serum biochemistry from a fasting blood sample

    Measured: 6 months

  23. Syndecan-1

    Serum biochemistry from a fasting blood sample

    Measured: 6 months

  24. Glypican

    Serum biochemistry from a fasting blood sample

    Measured: 6 months

  25. Hyaluronan

    Serum biochemistry from a fasting blood sample

    Measured: 6 months

  26. Total lipid peroxides

    Serum biochemistry from a fasting blood sample

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2022
  2. Study start1 Aug 2022
  3. Primary completion1 Jul 2027 (estimated)
  4. Study completion30 Sep 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05366933
Sponsor's protocol ID
NASA IRB STUDY00000448
Status last verified
May 2025
First submitted
29 Apr 2022
Last updated
22 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 31415055

  • 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.

    PubMed 28546443

  • 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.

    PubMed 30169456

  • 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.

    PubMed 34105833

  • 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.

    PubMed 28611153

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Vitamin B-Complex Supplement in people with Optic Disc Edema and Endothelial Dysfunction, run by National Aeronautics and Space Administration (NASA) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sara Zwart, PhD (2814833753, sara.zwart-1@nasa.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Optic Disc Edema (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05366933, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2025; AzTrials last refreshed its copy on 28 Oct 2026.

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