At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 20 enrolled
Drug / intervention
Hydroxocobalamin +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Double Blind Randomized Controlled Trial of High Dose Vitamin B12 in Septic Shock
In Brief
A Phase 2 clinical trial evaluating Hydroxocobalamin and Placebo for Septic Shock. Completed, enrolled 20 participants across 1 site.
Detailed Summary
This study will randomize 20 septic shock patients to receive either a single 5 gram dose of IV vitamin B12 (Cyanokit® Meridian Medical Technologies, Columbia, MD) versus placebo in addition to standard of care to test the feasibility of completing clinical and laboratory protocols.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSeptic Shock
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
First PostedDec 2018
Enrollment StartAug 2019
Primary CompletionFeb 2023
TodayJul 2026
First PostedDec 20, 2018
Enrollment StartAug 5, 2019
Primary CompletionFeb 23, 2023
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 7.5 years ago
Interventions
Hydroxocobalamindrug
Single IV administration of Vitamin B12
Placebodrug
Single IV administration of saline