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CTRI Number  CTRI/2026/02/104520 [Registered on: 23/02/2026] Trial Registered Prospectively
Last Modified On: 20/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Impact of vitamin b12 intake during pregnancy on baby growth and development 
Scientific Title of Study   Effect of vitamin b12 supplementation during pregnancy on infants vitamin b 12 status anthropometry and neurological status at six months a double blind placebo controlled randomized control trial  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr suresh chandra goyel  
Designation  Pims principal and controller  
Affiliation  Pacific institute of medical sciences  
Address  Pacific institute of medical sciences umarda udaipur

Udaipur
RAJASTHAN
313005
India 
Phone  9414220994  
Fax    
Email  deanpims@pacificmedicalsciences.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Dr suresh chandra goyel  
Designation  Pims principal and controller  
Affiliation  Pacific institute of medical sciences  
Address  Pacific institute of medical sciences umarda udaipur

Udaipur
RAJASTHAN
313005
India 
Phone  9414220994  
Fax    
Email  deanpims@pacificmedicalsciences.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr suresh chandra goyel  
Designation  Pims principal and controller  
Affiliation  Pacific institute of medical sciences  
Address  Pacific institute of medical sciences umarda udaipur

Udaipur
RAJASTHAN
313005
India 
Phone  9414220994  
Fax    
Email  deanpims@pacificmedicalsciences.ac.in  
 
Source of Monetary or Material Support  
None 
 
Primary Sponsor  
Name  Pacific institute of medical sciences  
Address  Pacific institute of medical sciences umarda udaipur rajasthan udaipur 313005 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sayantika chaudhuri   Pacific institute of medical sciences   Department of obstetrics and gynecology room 206 and department of pediatrics outpatient department room 110 and Indoor Ward 302
Udaipur
RAJASTHAN 		 9436971584

sayantika249chaudhuri@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee sai tirupati university udaipur rajasthan india   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O992||Endocrine, nutritional and metabolic diseases complicating pregnancy, childbirth and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Microcrystalline cellulose   A daily dose of 50 mg of micro crystalline tablet from the day of enrollment to 6 weeks postpartum 
Intervention  Vitamin B 12  A daily doses of 50 micrograms of vitamin b12 will be given from enrollment 3-6 weeks post-partum  
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  6.00 Month(s)
Gender  Both 
Details  Pregnant women aged more than equal to 18 years who will present for antenatal care before or at 14 weeks of gestational age as judged by the last menstrual period willing to provide informed consent and comply with study procedures will be eligible for inclusion. 
 
ExclusionCriteria 
Details  Those who anticipated moving out of the area before study completion
Who had twin or multiple pregnancies,
Those who were treated for infertility
Who tested positive for Hepatitis B Hepatitis B surface antigen HIV or Syphilis Venereal Disease Research Laboratory test infections, or
Who was taking daily vitamin supplements in addition to folic acid and iron
Women with a serious preexisting medical condition defined as the need for chronic or daily medication use. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Infant vitamin b12 status at birth and at 6 months of age

assessed by
serum vitamin b12 levels

 		 at birth and at 6 months of age 
 
Secondary Outcome  
Outcome  TimePoints 
Infant anthropometric parameters & neurodevelopmental status  At birth & six months of age 
 
Target Sample Size   Total Sample Size="130"
Sample Size from India="130" 
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)   01/04/2026 
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 Yet Recruiting 
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
Brief Summary   This thesis provide high quality casual evidence on whether maternal B12 supplementation improves infant vitamin b12 biochemical status at birth & six months determine effects on birth outcome and early growth and evaluate early neurodevelopmental using validated assessments at birth and six months . These results will directly inform clinical practice and public health policy on antenatal micronutrient interventions in populations at risk of vitamin b12 deficiency.  
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