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CTRI Number  CTRI/2026/02/104102 [Registered on: 17/02/2026] Trial Registered Prospectively
Last Modified On: 17/02/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Oral intake of 5 mg vitamin B12 during early pregnancy improves vitamin B12 status of mothers and offsprings 
Scientific Title of Study   Biochemical analysis of Breast Milk and children’s cardio-metabolic status to understand the beneficial effect of high oral dose B12 supplement during early pregnancy on the offspring. 
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 Sadanand S Naik  
Designation  Senior Consultant Biochemist  
Affiliation  Pathology Department Deenanath Mangeshkar Hospital and Research Center  
Address  Pathology Department Deenanath Mangeshkar Hospital and Research Center Erandwane Pune Pathology Department MAHARASHTRA India

Pune
MAHARASHTRA
411004
India 
Phone  8805375594  
Fax    
Email  sadu_naik@rediffmail.com   
 
Details of Contact Person
Scientific Query  
Name  Dr Sadanand S Naik  
Designation  Senior Consultant Biochemist  
Affiliation  Pathology Department Deenanath Mangeshkar Hospital and Research Center  
Address  Pathology Department Deenanath Mangeshkar Hospital and Research Center Erandwane Pune Pathology Department MAHARASHTRA India

Pune
MAHARASHTRA
411004
India 
Phone  8805375594  
Fax    
Email  sadu_naik@rediffmail.com   
 
Details of Contact Person
Public Query  
Name  Dr Sadanand S Naik  
Designation  Senior Consultant Biochemist  
Affiliation  Pathology Department Deenanath Mangeshkar Hospital and Research Center  
Address  Pathology Department Deenanath Mangeshkar Hospital and Research Center Erandwane Pune Pathology Department MAHARASHTRA India

Pune
MAHARASHTRA
411004
India 
Phone  8805375594  
Fax    
Email  sadu_naik@rediffmail.com   
 
Source of Monetary or Material Support  
Institute of Molecular Biology and Genetics Cellular Health Intervention Nutrition Aarhus University Universiteesbyen 83 Bldg 18741 8000 Aarhus Denmark and Deenanath Mangeshkar Hospital and Res CEntre Erandawane Pune India 
 
Primary Sponsor  
Name  Aarhus University Denmark 
Address  Institute of Molecular Biology and Genetics Cellular Health Intervention Nutrition Aarhus University Universiteesbyen 83 Bldg 18741 8000 Aarhus Denmark 
Type of Sponsor  Research institution and hospital 
 
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 Sadanand S Naik  Clinical Biochemistry department   Clinical Biochemistry Department First Floor Deenanath Mangeshkar Hospital and Res Centre Erandwane Pune 411 004 India Pune MAHARASHTRA
Pune
MAHARASHTRA 		 8805375594

sadu_naik@rediffmail.com  
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee for Biomedical and Health Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Pregnant Vegetarian women with with vitamin B12 deficiency (Pl. B12 less than 148 pmol/L)  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Cyano cobalamin  We supplemented B12 deficient pregnant women with high oral dose (5 mg/d) of CN-B12/CN B12/placebo at early stage for 2 weeks and then continued with 1.6 ug daily till delivery and 4 months postpartum, total duration 14+274 days 
Intervention  Milk cobalamin   We supplemented B12 deficient pregnant women with high oral dose (5 mg/d) of HO-B12/CN B12/placebo at early stage for 2 weeks and then continued with 2 x200 mL of milk daily till delivery and 4 months postpartum.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  34.00 Year(s)
Gender  Female 
Details  Confirmed pregnant women with plasma B12 less than 200 pg/ml 
 
ExclusionCriteria 
Details  Non vegetarians, cancer and the participants consuming vitamin B12 pills and the drugs known to influence vitamin B12 absorption
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Beneficial effect of Vitamin B12 supplementation on breast milk and off-springs   Early pregnancy to 4 months postpartum  
 
Secondary Outcome  
Outcome  TimePoints 
Normal birth weight children and healthy cardiometabolic status  Early pregnancy to 4 months postpartum  
 
Target Sample Size   Total Sample Size="76"
Sample Size from India="76" 
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)   04/03/2026 
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="3"
Months="0"
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
Brief Summary   We aim to measure breast milk compositions (Carbohydrate, fat, lipid, protein, B2, B6, B12) at delivery and 4 months and children’s cardio-metabolic status in offspring at birth (cord blood) and 4 months postpartum (lipid, insulin, adiponectin, leptin, glucose) in this prospective sample study.  
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