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Vitamin Supplement

Vitamin B-Complex for Optic Disc Swelling

Phase 1

Recruiting

Led By Sara R Zwart, PhD

Research Sponsored by National Aeronautics and Space Administration (NASA)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study Summary

This trial will test whether a daily supplement containing B vitamins can help mitigate optic disc edema in astronauts.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While specific side effects are not listed, typical reactions to vitamin B-complex supplements may include nausea, diarrhea, or increased urination. These vary from person to person.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Optic Disc Edema

Secondary outcome measures

3-nitrotyrosine

Advanced Glycation End Products (AGE)

Advanced glycation end products

+23 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Supplemented with B-ComplexExperimental Treatment1 Intervention

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

Do I qualify?Apply below to find out

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Mayo ClinicOTHER

3,210 Previous Clinical Trials

3,767,238 Total Patients Enrolled

9 Trials studying Endothelial Dysfunction

682 Patients Enrolled for Endothelial Dysfunction

Texas A&M UniversityOTHER

140 Previous Clinical Trials

24,090 Total Patients Enrolled

National Aeronautics and Space Administration (NASA)Lead Sponsor

24 Previous Clinical Trials

1,750 Total Patients Enrolled

Media Library

Vitamin B-Complex Supplement (Vitamin Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT05366933 — Phase 1

Endothelial Dysfunction Research Study Groups: Supplemented with B-Complex

Endothelial Dysfunction Clinical Trial 2023: Vitamin B-Complex Supplement Highlights & Side Effects. Trial Name: NCT05366933 — Phase 1

Vitamin B-Complex Supplement (Vitamin Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05366933 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this clinical experiment presently recruiting?

"Clinicaltrials.gov data elucidates that this trial is presently enrolling participants, with its introduction to the public on August 1st 2022 and a recent update made September 26th 2022."

Answered by AI

How many individuals are being monitored in this clinical investigation?

"Affirmative. Per the information available on clinicaltrials.gov, this experiment is still recruiting subjects, having been initially published on August 1st 2022 and most recently revised on September 26th 2022. The research requires 16 people from a single site to participate."

Answered by AI

Has the FDA sanctioned this B-Complex product?

"The safety rating of the Supplemented with B-Complex is a 1 on our team's scale due to its Phase 1 designation. This indicates that there is minimal evidence for both efficacy and safety."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

B-Complex: A Nutraceutical SANS Countermeasure

Sara R. Zwart, PhD 2022. "B-Complex: A Nutraceutical SANS Countermeasure". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05366933.