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CTRI Number  CTRI/2022/01/039091 [Registered on: 03/01/2022] Trial Registered Prospectively
Last Modified On: 19/11/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Other 
Public Title of Study   Vitamin D supplements during pregnancy 
Scientific Title of Study   Oral Vitamin D supplementation as a safe, affordable treatment for profound vitamin D deficiency in pregnancy 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pratibha Dwarkanath 
Designation  Associate Professor 
Affiliation  St John’s Research Institute 
Address  Division of Nutrition,St John’s Research Institute, Opp BDA Complex, Koramangala, Bangalore – 560034, India

Bangalore
KARNATAKA
560034
India 
Phone  9880714118  
Fax    
Email  pratibha@sjri.res.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Pratibha Dwarkanath 
Designation  Associate Professor 
Affiliation  St John’s Research Institute 
Address  Division of Nutrition,St John’s Research Institute, Opp BDA Complex, Koramangala, Bangalore – 560034, India

Bangalore
KARNATAKA
560034
India 
Phone  9880714118  
Fax    
Email  pratibha@sjri.res.in  
 
Details of Contact Person
Public Query  
Name  Dr Pratibha Dwarkanath 
Designation  Associate Professor 
Affiliation  St John’s Research Institute 
Address  Division of Nutrition,St John’s Research Institute, Opp BDA Complex, Koramangala, Bangalore – 560034, India

Bangalore
KARNATAKA
560034
India 
Phone  9880714118  
Fax    
Email  pratibha@sjri.res.in  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  Medical Research Council  
Address  Medical Research Institute, United Kingdom Research and Innovation 
Type of Sponsor  Government funding agency 
 
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 Pratibha Dwarkanath  St. John’s Research Institute & Medical College Hospital  Department of Obstetrics and Gynecology,St. John’s Medical College Hospital, St. John’s National Academy of Health Sciences, Sarjapur Road, Bangalore - 560034, India
Bangalore
KARNATAKA 		 8022065000

pratibha@sjri.res.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
St. Johns Medical College Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Apparent healthy pregnant women, (18-40 years of age), within 13 weeks of gestation Vitamin D deficiency 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Active Comparator: Daily 500 IU Vitamin D3 tablets (Standard dose)  Pregnant woman in this arm will be provided and counselled to take two tablets each containing 250 IU vitamin D3 and 00mg of elemental calcium to make it to 500 IU vitamin D3 and 1000mg elemental calcium per day which is part of their regular antenatal care. 
Intervention  Experimental: Daily 2000 IU Vitamin D3  In this arm, pregnant women with vitamin D deficiency will be counselled to take two tablets daily (each containing 1000 IU vitamin D3 and 500mg of elemental calcium) to make it to 2000 IU vitamin D3 and 1000mg elemental calcium 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Apparent healthy pregnant woman (18-40 years), before 13 weeks of gestation, willing to give informed consent, oblige to protocol regime, consume assigned supplement, and give blood samples. 
 
ExclusionCriteria 
Details  Pregnant women with twins or multiple pregnancies, chronic morbidities, on medication or undergoing treatment, or consuming multi-vitamins, have infections such as HIV, VDRL, HBsAg, assisted pregnancy, or anticipate discontinuing or moving out of the study site. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pharmacy-controlled Randomization 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To perform an open label study of 2000IU vitamin D3/d supplementation

from second trimester of pregnancy until delivery to determine whether

this supplemental dose results in vitamin D repletion after intervention 		 Assessment of Total Vitamin D, PTH levels in maternal venous blood during pregnancy (14, 24 and 34 weeks of gestation).

from second trimester of pregnancy until delivery to determine whether

this supplemental dose results in vitamin D repletion after intervention 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the innate immunity in the newborn of the mothers

supplemented with 2000IU vitamin D3 during pregnancy

· To archive maternal blood and cord blood for future studies on

the impact of maternal genotype (VDR, VDBP) on efficacy of

repletion.

· To build a cross-disciplinary consortium of healthcare

professionals, scientists, clinicians, and policy

makers/regulatory authorities along with international experts

and host a workshop in Bangalore, India with a definitive

scholarly peer-reviewed output of wider benefit nationally and

internationally, to inform the future direction of vitamin D

studies across India. 		 Cord blood collection during delivery Maternal venous blood during pregnancy (14, 24 and 34 weeks of gestation) and cord blood at delivery Workshop to be hosted in May/June 2022 and proceedings to be published in July/August 2022. 
 
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   Phase 2 
Date of First Enrollment (India)   04/01/2022 
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="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Global evidence that vitamin D sufficiency from early pregnancy, potentially pre-conception, till term

is safe and beneficially impacts maternal and neonatal outcomes are increasingly compelling.

However, concerns exist across India related to safety and efficacy in pregnancy of >400-500 IU/d

vitamin D during pregnancy. Our study aims to address these concerns directly through a pilot

intervention study of supplementing 2000IU vitamin D3/d during pregnancy, though building a cross-

India consortium and discussion with international experts to capacity build, train, debate and

subsequently plan a large-scale multi-center study in India with potential to address a range of

clinical and mechanistic outcomes. Correcting the profound levels of deficiency in pregnancy in

LMIC such as India reflects an affordable and safe intervention with a potentially major public health

impact in improving maternal and infant outcomes.

 
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