| CTRI Number |
CTRI/2026/01/101543 [Registered on: 19/01/2026] Trial Registered Prospectively |
| Last Modified On: |
16/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Other (Specify) |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study to see whether vitamin B12 or vitamin D supplements can reduce confusion (delirium) in patients admitted to the intensive care unit.
|
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Scientific Title of Study
|
Comparing the efficacy of vitamin B12 and vitamin D supplementation versus placebo in the prevention of delirium in critically ill patients:A Prospective Randomized Controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chethan V |
| Designation |
Senior Resident, DM Critical Care Medicine |
| Affiliation |
All India Institute of Medical Sciences, Jodhpur |
| Address |
Department of Anaesthesiology and Critical Care Medicine,
All India Institute of Medical Sciences, Jodhpur,
Marudhar Industrial Area Phase II, Basni,
Jodhpur, Rajasthan
Victorian Palace, A2 Block,
Shobhawaton Ki Dhani, Khema Ka Kua,
AIIMS Road, Jodhpur – 342001,
Rajasthan
Jodhpur
RAJASTHAN
342005
India |
| Phone |
09972491570 |
| Fax |
|
| Email |
chethanvamshi20@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pradeep Kumar Bhatia |
| Designation |
Professor and Head of the Department |
| Affiliation |
All India Institute of Medical Sciences, Jodhpur |
| Address |
Department of Anaesthesiology and Critical Care Medicine.
All India Institute of Medical Sciences, Jodhpur,
Marudhar Industrial Area Phase II, Basni,
Jodhpur, Rajasthan
Department of Anaesthesiology and Critical Care Medicine,
All India Institute of Medical Sciences, Jodhpur,
Marudhar Industrial Area Phase II, Basni,
Jodhpur, Rajasthan
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9829159665 |
| Fax |
|
| Email |
pk_bhatia@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Chethan V |
| Designation |
Senior Resident, DM Critical Care Medicine |
| Affiliation |
All India Institute of Medical Sciences, Jodhpur |
| Address |
Department of Anaesthesiology and Critical Care Medicine,
All India Institute of Medical Sciences, Jodhpur,
Marudhar Industrial Area Phase II, Basni,
Jodhpur, Rajasthan
Victorian Palace, A2 Block,
Shobhawaton Ki Dhani, Khema Ka Kua,
AIIMS Road, Jodhpur – 342001,
Rajasthan
Jodhpur
RAJASTHAN
342005
India |
| Phone |
09972491570 |
| Fax |
|
| Email |
chethanvamshi20@gmail.com |
|
|
Source of Monetary or Material Support
|
| This is an investigatorinitiated academic study conducted as part of postgraduate research.
No external monetary or material support has been received. Study interventions are provided from routine hospital resources.
|
|
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Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Jodhpur |
| Address |
Department of Anaesthesiology and Critical Care Medicine,
All India Institute of Medical Sciences, Jodhpur,
Marudhar Industrial Area Phase II, Basni,
Jodhpur, Rajasthan.
|
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Chethan V |
All India Institute of Medical Sciences, Jodhpur |
Department of Anaesthesiology and Critical Care Medicine,
Adult Intensive Care Unit,
3rd Floor,
All India Institute of Medical Sciences, Jodhpur,
Rajasthan
Jodhpur
RAJASTHAN |
09972491570
chethanvamshi20@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R098||Other specified symptoms and signsinvolving the circulatory and respiratory systems, (2) ICD-10 Condition: J22||Unspecified acute lower respiratory infection, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo
|
Participants in this group will receive placebo in the form of normal saline along with standard intensive care unit care as per institutional protocol.
|
| Intervention |
Vitamin B12 and vitamin D supplementation.
|
Participants in this group will receive cobalamin (vitamin B12) 1000 mcg intravenously once daily from day 1 to day 7, along with vitamin D 60000 IU administered as a single oral dose.
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Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged twenty five to seventy five years admitted to the ICU. Patients with a Glasgow Coma Scale score of eight or above and a Richmond Agitation Sedation Scale score minus three or above. Patients are expected to stay in the ICU for at least forty eight hours.
|
|
| ExclusionCriteria |
| Details |
Patients refused to participate in the study. Patients aged below twenty five years or above seventy five years. Patients with a Glasgow Coma Scale score below eight or a Richmond Agitation Sedation Scale score below minus three. Patients with traumatic brain injury. Patients with severe septic shock and multi-organ dysfunction.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Incidence of delirium in patients recieving vitamin b12 and vitamin D during ICU stay.
|
Baseline assessment within 24 hours of ICU admission, followed by daily assessment during ICU stay until ICU discharge.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
TO assess
1.Serum levels of vitamin B12 & vitamin D.
2.Duration of ICU stay.
3.Number of delirium free days during ICU stay.
4.Cognitive function at ICU discharge.
5.Quality of life at hospital discharge.
|
Baseline assessment within 24 hours of ICU admission, followed by daily assessment during ICU stay until ICU discharge.
|
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Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
Delirium is a transient acute neuropsychiatric disorder characterized by altered consciousness impaired attention and cognitive dysfunction and is common among critically ill patients admitted to the intensive care unit. The incidence of delirium in the intensive care unit is high and is associated with increased morbidity mortality and prolonged hospital stay. Several modifiable and non modifiable risk factors contribute to the development of delirium including malnutrition and vitamin deficiencies. This study is a prospective randomized controlled trial designed to evaluate whether supplementation with vitamin B12 and vitamin D reduces the incidence of delirium in critically ill patients. Eligible patients admitted to the intensive care unit will be enrolled after obtaining informed consent from the patient or legally authorized representative. Participants will be randomly allocated into two groups using a computer generated randomization sequence with allocation concealment by sealed opaque envelopes.
Patients in the intervention group will receive vitamin B12 and vitamin D supplementation in addition to standard intensive care treatment. Patients in the control group will receive placebo along with standard intensive care treatment including nutrition and multivitamin supplementation as per intensive care unit protocol. Delirium will be assessed using standardized clinical tools during the intensive care unit stay. The primary outcome of the study is the incidence of delirium during intensive care unit stay. Secondary outcomes include serum levels of vitamin B12 and vitamin D duration of intensive care unit stay number of delirium free days cognitive function at intensive care unit discharge and quality of life at hospital discharge. This study aims to evaluate a simple and potentially cost effective strategy for the prevention of delirium in critically ill patients. |