A Trial of Vitamin B12 in Septic Shock

What Was Tested

The trial (phase 2) is built around Cyanocobalamin (Vitamin B12).

It had two arms (groups): Hydroxocobalamin (experimental) and Saline Placebo (placebo comparator).

Single IV infusion administered over a 10-15 minute period.

Single IV saline administered over a 10-15 minute period.

The registry classes the interventions as drug.

More on the Plan

Following informed consent from patient's legally authorized representative, patients will be randomized to hydroxocobalamin or saline.

Who Took Part

Enrollment: 20 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Adult patients at least 18 years of age. Diagnosis of septic shock, as defined by sepsis-3 criteria.

The full record lists 3 inclusion and 1 exclusion criteria; among the exclusions: history of calcium oxaluria.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

The participants were allocated by chance, so the Cyanocobalamin (Vitamin B12) group and the comparison group should start out alike.

The Cyanocobalamin (Vitamin B12) group and the comparison group ran side by side rather than switching.

As a double-blind Cyanocobalamin (Vitamin B12) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2019-08-05 with completion listed for 2023-02-23.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Feasibility of Clinical and Protocol Completion (time frame: 28 days).

It also tracked 4 secondary outcomes, for example Hydrogen Sulfide Concentration, Persistent Organ Dysfunction Syndrome (PODS) and ICU Mortality.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Cyanocobalamin (Vitamin B12) in 20 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Cyanocobalamin (Vitamin B12) compound page, all human trials.