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Could vitamin B12 help fight septic shock?

NCT ID NCT03783091

Disease control Sponsor: Medical College of Wisconsin Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether giving a single high dose of vitamin B12 (5 grams) to 20 adults with septic shock is feasible and safe. Patients received either vitamin B12 or a placebo (saline) alongside standard care. The main goal was to see if the study procedures could be completed, not to prove the treatment works. Results are not yet known.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
high-dose vitamin B12 (hydroxocobalamin)
What this could lead to
If it works, this could point toward a simple, safe add-on treatment to reduce organ failure in septic shock.
What could go wrong
This is a very small, early-phase feasibility trial with only 20 patients. It is not designed to prove effectiveness, and the results may not apply to all septic shock patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

20 people

The number who actually took part.

Started

Aug 2019

Finished

Feb 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adult patients at least 18 years of age * Admitted to the Medical Intensive Care Unit (MICU) service at Froedtert Hospital * Diagnosis of septic shock, as defined by sepsis-3 criteria Exclusion Criteria: * History of calcium oxaluria

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Conditions

The condition(s) this trial relates to.

toxic shock syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Septic shock

Contacts and locations

Locations

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.