Study on the Improvement of Microcirculation in Patients With Sepsis by Vitamin B6, Vitamin B12 and Vitamin C

What Was Tested

In this not phased trial, researchers set out to test Cyanocobalamin (Vitamin B12).

Sepsis is a kind of disease with high morbidity and mortality in ICU.

At present, there is no specific treatment, and its pathogenesis is mainly excessive oxidative stress.

Anti-inflammatory, antioxidant and immune-regulating drugs may produce better therapeutic effects, while vitamin B6, vitamin B12 and vitamin C have anti-inflammatory, antioxidant and immune-regulating effects.

It had four arms (groups): Experimental group (experimental), Control group 1 (active comparator), Control group 2 (active comparator) and Control group 3 (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 296 planned participants were the target.

It was open to people of any sex aged from 18 years up to 85 years.

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

Examples of who could join: Age ≥18 and \< 85 years old. Admitted to ICU. Diagnosis of patients with SEPSIS 3.0 (diagnostic criteria) 4, SOFA score is 2-13 points.

The full record lists 3 inclusion and 10 exclusion criteria; among the exclusions: patients have absolute contraindications such as vitamin allergy; patients with a history of gout; pregnant women.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Cyanocobalamin (Vitamin B12).

Those kept unaware of assignments: participant and investigator.

It started in 2025-02-10 with completion listed for 2026-02-28.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 9 secondary outcomes, for example The duration of the patient's use of pressor drugs, Number of days on ventilator, ICU stay, 28-day mortality, Capillary refill time and Changes in SOFA score.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Cyanocobalamin (Vitamin B12) in 296 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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