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CTRI Number  CTRI/2025/06/089254 [Registered on: 20/06/2025] Trial Registered Prospectively
Last Modified On: 12/08/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing high dose versus standard dose vitamin B12 in premature babies- a clinical trial 
Scientific Title of Study   Comparison of high dose vitamin B12 versus standard dose vitamin B12 supplementation in preterm neonates born at 28 to 33 weeks of gestation- a 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  Dr Nishant Banait 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences, Nagpur 
Address  Department of Neonatology, AIIMS Nagpur, MIHAN, Nagpur, Sumthana, Dahegaon, Maharashtra

Nagpur
MAHARASHTRA
441108
India 
Phone  9673998494  
Fax    
Email  nishantbanait@aiimsnagpur.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Mansi Madan 
Designation  Senior Resident (Academic) 
Affiliation  All India Institute of Medical Sciences, Nagpur 
Address  Department of Neonatology, AIIMS Nagpur, MIHAN, Nagpur, Sumthana, Dahegaon, Maharashtra

Nagpur
MAHARASHTRA
441108
India 
Phone  8708247979  
Fax    
Email  madanmansiisme@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Mansi Madan 
Designation  Senior Resident (Academic) 
Affiliation  All India Institute of Medical Sciences, Nagpur 
Address  Department of Neonatology, AIIMS Nagpur, MIHAN, Nagpur, Sumthana, Dahegaon, Maharashtra

Nagpur
MAHARASHTRA
441108
India 
Phone  8708247979  
Fax    
Email  madanmansiisme@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Nagpur, MIHAN, Nagpur, Sumthana, Dahegaon, Maharashtra 441108, India 
 
Primary Sponsor  
Name  Dr Nishant Banait 
Address  Department of Neonatology, AIIMS Nagpur, MIHAN, Nagpur, Sumthana, Dahegaon, Maharashtra 441108 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Dr Mansi Madan  Department of Neonatology, AIIMS Nagpur, MIHAN, Nagpur, Sumthana, Dahegaon, Maharashtra 441108 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mansi Madan  AIIMS Nagpur  IPD NICU 303, Department of Neonatology, AIIMS Nagpur, MIHAN, Nagpur, Sumthana, Dahegaon, Maharashtra 441108
Nagpur
MAHARASHTRA 		 8708247979

madanmansiisme@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Nagpur Institutional Ethics Comiittee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: P073||Preterm [premature] newborn [other],  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  High dose Vitamin B12  Babies will receive high dose injection vitamin B12. Route: Intramuscular injection Dose: 25 mcg Frequency: starting from day 7 of life, repeated every 7 days during hospital stay until discharge. 
Comparator Agent  Standard dose Vitamin B12  Standard of care for anemia of prematurity prevention-(syrup)- including iron, folic acid and vitamin B12. Route: oral Dose: based on 0.12ml/kg-0.24ml/kg of iron, which contains 0.6 mcg/kg-1.2mcg/kg of vitamin B12 daily Frequency: Everyday starting from day 14 of life till discharge 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  28.00 Day(s)
Gender  Both 
Details  Preterm neonates between 28+0-33+6 weeks’ of gestation admitted to the NICU at AIIMS Nagpur.
 
 
ExclusionCriteria 
Details  1. Out-born preterm neonates between 28+0-33+6 weeks’ of gestation admitted after 24 hours of birth to the NICU at AIIMS Nagpur.
2. Parents and guardians unwilling to provide consent for the study.
3. Major congenital malformation.
4. Hemolytic disease.
5. Twin to twin transfusion syndrome.
6. Major hemorrhage (including IVH grade III/IV, major GI bleed, UVC bleed, history of peripartum hemorrhage).
 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in hemoglobin (Hb) levels from baseline to 4 weeks of age.  Baseline Hb will be evaluated with CBC within 24 hours of birth and repeated every 7 days before administration of next dose of intramuscular injection of vitamin B12 till discharge. Change in Hb levels will be assessed. 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in the incidence of anemia.   Baseline Complete blood count will be taken within 24 hours of birth and repeated every 7 days before administration of next dose of intramuscular injection of vitamin B12 till discharge. Anemia will be diagnosed based on available reference charts. 
Change in RBC indices (MCV, RBC count, reticulocyte count).  Baseline Complete blood count will be taken within 24 hours of birth and repeated every 7 days before administration of next dose of intramuscular injection of vitamin B12 till discharge.
Reference values will be compared with charts as mentioned in Annexures 
Change in serum vitamin B12 levels.  Baseline value of serum Vitamin B12 will be taken within 24 hours of life and then repeated every 14 days, before administration of dose of intramuscular injection of vitamin B12 till discharge. 
Incidence of anemia requiring blood transfusion.  Baseline Complete blood count will be taken within 24 hours of birth and repeated every 7 days before administration of next dose of intramuscular injection of vitamin B12 till discharge. Blood transfusion cut- off will be decided as per unit protocol as mentioned in annexure. 
Association between maternal serum B12 and neonatal serum B12 levels.  Maternal serum Vitamin B12 levels will be assessed once at baseline, i.e. within 24 hours of delivery. 
Change in growth parameters on receiving vitamin B12 therapy  Anthropometry recordings of length, weight and head circumference will be done at admission then once every week till discharge. 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   Phase 4 
Date of First Enrollment (India)   01/07/2025 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Anemia is a common condition in preterm neonates, with prevalence ranging from 6-70% based on gestational age. It can lead to complications such as apnea, bradycardia, tachycardia, tachypnea, lethargy, and inadequate weight gain. Vitamin B12 is crucial for erythropoiesis and neonatal health, but supplementation practices vary, and its role in anemia prevention in preterm neonates remains underexplored. By conducting this study, we aim to fill this gap and provide evidence to guide clinical practices for managing anemia in preterm neonates. 

This study aims to evaluate the effect of high dose vitamin B12 supplementation in preterm neonates between 28+0-33+6 weeks’ of gestation admitted in a tertiary care hospital on reducing the incidence and severity of anemia. 

A prospective, randomized controlled trial will be conducted at the Department of Neonatology, AIIMS Nagpur, where eligible neonates will be randomized into intervention and control groups using block randomization. Baseline assessment of CBC and Vitamin B12 will be done within 24 hours of birth. The intervention group will receive high-dose vitamin B12, while the control group will receive standard care with iron, folic acid, and vitamin B12. Babies allocated in the intervention group will receive high dose (25 mcg) vitamin B12 supplementation via intramuscular route starting at day 7 of life, and repeated every 7 days until discharge. Babies allocated in the control group will receive standard of care as per protocol- standard dose of vitamin B12, iron and folic acid starting at day 14 of life and everyday thereafter. Serial CBC assessment will be done every 7 days till discharge and serial vitamin B12 assessment will be done once at baseline, then every 14 days till discharge. Maternal serum vitamin B12 will also be assessed at baseline within 24 hours of delivery.

The primary objective is to evaluate the impact of high-dose vitamin B12 on hemoglobin levels from baseline to 4 weeks of age. Secondary objectives include assessing the reduction in anemia incidence, changes in RBC indices, serum vitamin B12 levels, anemia requiring transfusion, maternal and neonatal vitamin B12 correlation, and changes in growth parameters. 

Babies will be monitored during NICU stay until discharge and followed up till 4 months of chronological age on OPD basis once monthly after discharge.


 
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