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CTRI Number  CTRI/2010/091/000499 [Registered on: 19/05/2010]
Last Modified On:
Post Graduate Thesis   
Type of Trial   
Type of Study    
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study of the effect of vitamin D supplementation in pregnant women, on the growth and biochemical features of the newborn baby and infant. 
Scientific Title of Study   Vitamin D and calcium nutrition: deficiency and evaluation of supplementation. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vijayalakshmi Bhatia 
Designation   
Affiliation   
Address  Dept of endocrinology
SGPGIMS, Raebareli Road
Lucknow
UTTAR PRADESH
226014
India 
Phone  +91-522-2494380  
Fax  +91-522-2668017  
Email  vbhatia@sgpgi.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Vijayalakshmi Bhatia 
Designation   
Affiliation   
Address  Dept of endocrinology
SGPGIMS, Raebareli Road
Lucknow
UTTAR PRADESH
226014
India 
Phone  +91-522-2494380  
Fax  +91-522-2668017  
Email  vbhatia@sgpgi.ac.in  
 
Details of Contact Person
Public Query  
Name  Vijayalakshmi Bhatia 
Designation   
Affiliation   
Address  Dept of endocrinology
SGPGIMS, Raebareli Road
Lucknow
UTTAR PRADESH
226014
India 
Phone  +91-522-2494380  
Fax  +91-522-2668017  
Email  vbhatia@sgpgi.ac.in  
 
Source of Monetary or Material Support  
Indian Council for Medical Research 
 
Primary Sponsor  
Name  Department of endocrinology, SGPGIMS, Lucknow 
Address   
Type of Sponsor   
 
Details of Secondary Sponsor  
Name  Address 
Department of obstetrics and gynecology, Queen Mary's Hospital, Chatrapati Sahuji Maharaj Medical University, Lucknow.   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vijayalakshmi Bhatia  Dept of endocrinology  Sanjay Gandhi Postgraduate Institute of Medical Sciences,-226014
Lucknow
UTTAR PRADESH 		 +91-522-2668004
+91-522-2668017
vbhatia@sgpgi.ac.in 
Dr Vinita Das  Dept of Obstetrics and Gynecology  Queen Mary's Hospital,Chhatrapati Sahuji Maharaj Medical University-226003
Lucknow
UTTAR PRADESH 		 +91-522-2257742
+91-522-2257742
das_lko@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee of SGPGIMS, Lucknow  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Vitamin D deficiency,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Oral calcium  1 gm elemental calcium by mouth daily, as caclium carbonate without vitamin D. 
Intervention  Oral vitamin D3  Group 1 receives one sachet of 60,000 units of D3 by mouth, in mid trimester; group 2 receives 2 sachets in mid trimester and 2 sachets in 7th month of pregnancy. Both groups receive 1 gm elemental calcium as calcium carbonate, daily orally. 
 
Inclusion Criteria  
Age From   
Age To   
Gender   
Details  All pregnant women who attend antenatal clinic of one unit of Queen Mary Hospital, Chhatrapati Sahuji Maharaj Medical University, Lucknow, are recruited as subjects and randomised to receive one of the 2 intervention regimes. Consecutive women who attend antenatal clinic too near term to be included in the study to serve as controls.  
 
ExclusionCriteria 
Details  Patients already on calcium or on vitamin D supplementation, on anticonvulsants, on antitubercular treatment or having any medical condition affecting calcium and vitamin D metabolism (e.g. renal or liver disease).  
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Neonatal serum calcium   At 4 to 6 day of life 
 
Secondary Outcome  
Outcome  TimePoints 
Baby weight, length, head circumference, anterior fontanelle diameter  Birth 
Baby weight, length, head circumference, anterior fontanelle diameter  3 month of age 
Baby weight, length, head circumference, anterior fontanelle diameter  Six month of age 
Baby weight, length, head circumference, anterior fontanelle diameter  Nine month of age 
Cord blood 25 OHD3   Birth  
Cord blood alkaline phosphatase  Birth 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="" 
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 3 
Date of First Enrollment (India)   Date Missing 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  27/02/2006 
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)   Completed 
Recruitment Status of Trial (India)   
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   This is a pilot randomised study to see the efficacy of 2 dose regimens of oral vitamin D3 in pregnant women with regard to the following outcomes, in comparison with women who receive standard therapy of calcium alone: primary outcome: to maintain newborn serum calcium in better range, in other words, in preventing neonatal hypocalcemia; secondary aims: in maintaining better cord blood 25 OHD and alkaline phosphatase, ie, in preventing vitamin D deficiency in the baby, and the harmful effect of its deficiency on baby's bone health. Another secondary outcome: to maintain improved anthropometry of the baby at birth and at ages upto 1 year. 
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