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Effect of vitamin B12 on delirium

Investigating the Preventive Efficacy of Intramuscular Vitamin B12 Injection on Delirium Incidence in Patients Admitted to Intensive Care Units: A Randomized Controlled Clinical Trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20150221021159N12
Enrollment
30
Registered
2025-06-17
Start date
2025-09-23
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delirium. Delirium due to known physiological condition

Interventions

Intervention 1: Intervention group: In the intervention group, in addition to standard supports, one intravenous vitamin B12 injection ( 1000 micrograms) will be administered daily for 3 days. Interve

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Adult patients (18 years and older) at the time of admission to the Intensive Care Unit (ICU) No history of delirium, mood disorders, or alcohol dependence prior to ICU admission An estimated minimum of 7 days of ICU stay A risk of delirium based on the PREDELIRIC score equal to or greater than 40% at the time of study entry Absence of visual and hearing impairments Absence of liver failure

Exclusion criteria

Exclusion criteria: Patients with GCS= 8 patients with a score of -4 or -5 on The Richmond Agitation-Sedation Scale (RASS) Any condition that makes delirium assessment based on the CAM-ICU index for at least 5 days impossible Inability to collect samples for evaluating vitamin B12 levels at the end of the study

Design outcomes

Primary

MeasureTime frame
Incidence of delirium. Timepoint: Daily evaluation of delirium incidence for 7 days following study recruitment. Method of measurement: Calculate Confusion Assessment Method for the Intensive Care Unit (CAM-ICU).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactShadi Farsaei

Esfahan University of Medical Sciences

Farsaei@pharm.mui.ac.ir+98 31 3792 7071

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026