Vitamin B-Complex for Optic Disc Swelling

Overseen By Sara Zwart, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: National Aeronautics and Space Administration (NASA)

Must not be taking: B-vitamin supplements

Disqualifiers: Non-astronauts, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

16 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a daily vitamin B-complex supplement can reduce optic disc swelling (eye pressure changes) in astronauts. The goal is to determine if these vitamins can improve eye health during and after long space missions by supporting essential body processes. Astronauts traveling to the International Space Station for 6 to 12 months and not currently taking B-vitamin supplements might be suitable candidates. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this potential new treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking all current medications, but you cannot participate if you are taking B-vitamin supplements.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that vitamin B-complex supplements are generally safe for most people. Studies have found that the body doesn't store extra B vitamins, so daily intake is usually okay. Specifically, vitamin B5, part of this group, is unlikely to cause harm even with long-term use. In short, vitamin B-complex supplements are well-tolerated and carry a low risk of serious side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard of care for optic disc swelling, which often involves medications like corticosteroids or surgery, the Vitamin B-Complex supplement provides a unique approach by potentially addressing the condition through nutritional support. Researchers are excited about this treatment because it could offer a non-invasive option that might help protect and support the optic nerve during the stress of spaceflight. Additionally, the use of a vitamin supplement is appealing due to its potential for fewer side effects compared to traditional medical interventions.

What evidence suggests that this Vitamin B-Complex Supplement is effective for optic disc swelling?

Research has shown that a lack of certain B vitamins, especially B1 and B12, links to swelling of the optic disc, a part of the eye. One study found that 41.5% of people with this eye swelling had these vitamin deficiencies. Evidence also suggests that B vitamins can influence genetic factors related to this eye condition. This trial will explore whether taking a B-complex vitamin could enhance eye health by supporting vital body functions, such as maintaining healthy blood vessels and strengthening collagen. Although specific data on astronauts is limited, these findings imply that B vitamins might aid vision problems during space missions. Participants in this trial will take a vitamin B-complex supplement before, during, and after a 6-12 month spaceflight on the International Space Station. ^{1 6 7 8 9}

Who Is on the Research Team?

Sara R Zwart, PhD

Principal Investigator

UTMB

Are You a Good Fit for This Trial?

This trial is for astronauts scheduled for 6-12 month missions on the International Space Station. It's not open to those already taking B-vitamin supplements.

Inclusion Criteria

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

Exclusion Criteria

I am taking B-vitamin supplements.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-flight Assessment

Fasting blood samples collected and analyzed for vitamin status and one-carbon biochemistry approximately 180 days and 45 days before flight

6 months

2 visits (in-person)

In-flight Treatment

Participants take a vitamin B-complex supplement during a 6-12 month spaceflight on the International Space Station

6-12 months

Continuous monitoring

Post-flight Assessment

Blood samples collected and analyzed for vitamin status and one-carbon biochemistry, and OCT scans performed to measure retinal thickness

1 month

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Vitamin B-Complex Supplement

Trial Overview The study tests if a daily supplement of bioactive B vitamins can prevent optic disc swelling in astronauts by optimizing certain metabolic pathways and improving vascular and ocular health.

How Is the Trial Designed?

Group I: Supplemented with B-Complex Experimental Treatment 1 Intervention

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

Vitamin B-Complex Supplement is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Vitamin B-Complex Supplement for:

• General health and wellness
• Prevention of vitamin deficiencies

Approved in European Union as Vitamin B-Complex Supplement for:

• General health and wellness
• Prevention of vitamin deficiencies

Approved in Canada as Vitamin B-Complex Supplement for:

• General health and wellness
• Prevention of vitamin deficiencies

Who Is Running the Clinical Trial?

National Aeronautics and Space Administration (NASA)

Lead Sponsor

Trials

32

Recruited

1,900+

Mayo Clinic

Collaborator

Trials

3,427

Recruited

3,221,000+

Texas A&M University

Collaborator

Trials

156

Recruited

28,900+

Published Research Related to This Trial

A study involving 973 school children found a significant link between vitamin B-complex deficiency signs and defective vision, suggesting that these deficiencies may contribute to visual problems.

Supplementation with vitamin B-complex vitamins improved visual acuity in children with defects and helped prevent the development of visual issues, indicating a potential 'cause and effect' relationship.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vitamin B-complex deficiency and visual acuity. Damodaran, M., Rameshwar Sarma, KV., Tiar, A., et al.[2019]

Vitamin deficiencies can lead to serious eye health issues, and in some cases, eye problems may be the first signs of a deficiency, highlighting the importance of early detection and treatment.

This review covers the ocular effects of several key vitamins (A, B1, B2, B9, B12, C, D, E, and K), emphasizing the need for ophthalmologists to recognize these symptoms to prevent severe complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association Between Vitamin Deficiencies and Ophthalmological Conditions. Pereira, A., Adekunle, RD., Zaman, M., et al.[2023]

Non-arteritic anterior ischemic optic neuropathy (NA-AION) was found to be the most common cause of optic disc swelling, accounting for 34.7% of cases in a study of 49 patients.

Optic neuritis (ON) was also prevalent, affecting 30.6% of patients, and was associated with more ocular pain and a better expected visual prognosis compared to NA-AION, highlighting the importance of differentiating between these conditions for effective management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of the causes of optic disc swelling. Jung, JJ., Baek, SH., Kim, US.[2021]

In a study of 25 patients with optic neuritis, intravenous vitamin C treatment significantly increased low blood levels of vitamin C, which were found to be below normal levels, along with other vitamins and zinc.

While all treatment groups, including those receiving vitamin C, showed improved vision, there was no significant difference in visual acuity improvement among the groups, suggesting that intravenous vitamin C could be a viable treatment option for optic neuritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Optic neuritis and vitamin C]. Ichibe, Y., Ishikawa, S.[2015]

A 56-year-old woman developed severe optic disc swelling and visual changes after starting anastrozole therapy for breast and gynecological cancers, indicating a potential adverse effect of the medication.

Upon discontinuation of anastrozole, the patient experienced near-complete resolution of the optic swelling and improvement in vision within a month, suggesting that the visual disturbances were likely related to the drug.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bilateral Optic Disc Swelling Following Anastrozole Therapy. Coppes, OJ., Lukas, RV., Fleming, GF., et al.[2019]

A 19-year-old man with type 1 diabetes was found to have asymptomatic bilateral optic disc swelling due to significant vitamin B12 deficiency, detected through routine screening for retinopathy.

After receiving vitamin B12 replacement therapy, both his visual function and the appearance of the optic discs returned to normal, highlighting the importance of monitoring vitamin levels in diabetic patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vitamin B12 deficiency optic neuropathy detected by asymptomatic screening. Chu, C., Scanlon, P.[2021]

In a study of 66 patients over 7 years at the University of Benin Teaching Hospital, the most common causes of optic disc swelling were identified as papillitis, brain tumors, and tilted disc, highlighting the need for careful evaluation of these conditions.

The study found that papilledema, optic neuritis, and pseudopapilledema were the leading etiological processes, indicating that a range of serious and benign conditions can cause optic disc swelling, necessitating thorough clinical assessment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Etiology of Optic Disc Swelling in a Tertiary Care Center in Nigeria. Osaguona, VB., Kayoma, DH.[2022]

In a study of 36,580 participants over 13 years, high-dose B-vitamin supplements were linked to a 27% increased risk of developing age-related cataracts, particularly in younger individuals under 60 years old.

The risk of cataract associated with B-vitamin use varied by age, with the highest hazard ratio of 1.88 for those under 60, suggesting that younger individuals may be more susceptible to the adverse effects of high-dose B vitamins.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-dose B-vitamin supplements and risk for age-related cataract: a population-based prospective study of men and women. Selin, JZ., Lindblad, BE., Bottai, M., et al.[2022]

Chronic excessive intake of vitamin A can lead to papilledema, as demonstrated in three cases, with two patients experiencing blurred vision and systemic complaints that resolved within a week after stopping vitamin A.

Fluorescein angiography showed optic disk changes in these patients similar to those seen in other causes of papilledema, highlighting the importance of assessing vitamin A intake in patients presenting with this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optic disk findings in hypervitaminosis A. Marcus, DF., Turgeon, P., Aaberg, TM., et al.[2004]

A 44-year-old woman experienced progressive visual loss due to bilateral retrobulbar optic neuropathy, which was linked to severe folate deficiency, despite normal vitamin B12 levels.

Correction of her folate deficiency through oral supplementation resulted in improvement in her visual acuity, demonstrating the importance of recognizing nutritional deficiencies in cases of optic neuropathy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Folic acid deficiency optic neuropathy: a case report. de Silva, P., Jayamanne, G., Bolton, R.[2021]

This study analyzed data from multiple sources and found no significant differences in serum levels of vitamins B6, B12, or D between patients with different types of glaucoma (primary open-angle glaucoma, normal tension glaucoma, and exfoliative glaucoma) and healthy controls.

The results suggest that there is no clear association between serum vitamin levels and the risk or presence of glaucoma, indicating that vitamin deficiencies may not play a significant role in this eye condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lack of Association between Serum Vitamin B₆, Vitamin B12, and Vitamin D Levels with Different Types of Glaucoma: A Systematic Review and Meta-Analysis. Li, S., Li, D., Shao, M., et al.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05366933

B-Complex: A Nutraceutical SANS Countermeasure In this project, the investigators propose to test effectiveness of a daily nutraceutical supplement containing bioactive B vitamins to mitigate optic disc ...

2. nasa.gov nasa.gov/podcasts/houston-we-have-a-podcast/lets-b-complex/

Let's B-Complex NASA nutrition scientists discuss how a daily B vitamin supplement might prevent vision changes in astronauts during long-duration space missions.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9331791/

Micronutrient Deficiencies Presenting with Optic Disc Swelling ... We found 65 cases of optic disc swelling associated with deficiencies in vitamins A, B1 and B12; many (41.5%; 27/65) of these cases met current ...

4. ctv.veeva.com ctv.veeva.com/study/b-complex-a-nutraceutical-sans-countermeasure

B-Complex: A Nutraceutical SANS Countermeasure In this project, the investigators propose to test effectiveness of a daily nutraceutical supplement containing bioactive B vitamins to ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6696878/

Association of Genetics and B Vitamin Status With the ... The findings presented here document an association of genetics and B vitamin status with the development of optic disc edema in a ground-based ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8839250/

Biological Properties of Vitamins of the B-Complex, Part 1 Similarly, chronic toxicity of vitamin B5 is very low; hence, this vitamin is generally considered safe. No symptoms of chronic toxicity nor pathological ...

7. healthline.com healthline.com/health/food-nutrition/vitamin-b-complex

Do I Need Vitamin B Complex and Are Supplements Safe? Vitamin B complex appears to be safe for most people to take every day as the body does not store any excess. That said, it's important to follow the ...

8. mdpi.com mdpi.com/2072-6643/14/15/3068

Micronutrient Deficiencies Presenting with Optic Disc ... We found 65 cases of optic disc swelling associated with deficiencies in vitamins A, B1 and B12; many (41.5%; 27/65) of these cases met current diagnostic ...

9. webmd.com webmd.com/drugs/2/drug-3387/vitamins-b-complex-oral/details

Vitamin B Complex - Uses, Side Effects, and More Find patient medical information for Vitamin B Complex on WebMD including its uses, side effects and safety, interactions, pictures, ...