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CTRI Number  CTRI/2016/01/006578 [Registered on: 29/01/2016] Trial Registered Retrospectively
Last Modified On: 29/01/2016
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Vitamin B12 during pregnancy 
Scientific Title of Study   Vitamin B12: Its bioavailability and effect in a balanced protein supplement on sulfur amino acid and methyl transfer kinetics in Indian 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 Anura V Kurpad 
Designation  Professor  
Affiliation  St Johns National Academy of Health Sciences 
Address  Department of Physiology, Division of Nutrition, St John’s National Academy of Health Sciences, St. Johns Medical College, Sarjapur Road Bangalore

Bangalore
KARNATAKA
560034
India 
Phone  080-25532037  
Fax  080-25532037  
Email  a.kurpad@sjri.res.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anura V Kurpad 
Designation  Professor  
Affiliation  St Johns National Academy of Health Sciences 
Address  St John’s National Academy of Health Sciences Sarjapur Road Bangalore
St. Johns medical college Bangalore
Bangalore
KARNATAKA
560034
India 
Phone  080-25532037  
Fax  080-25532037  
Email  a.kurpad@sjri.res.in  
 
Details of Contact Person
Public Query
 
Name  Dr Anura V Kurpad 
Designation  Professor  
Affiliation  St Johns National Academy of Health Sciences 
Address  Department of Physiology, Division of Nutrition, St John’s National Academy of Health Sciences,St. Johns Medical College, Sarjapur Road Bangalore

Bangalore
KARNATAKA
560034
India 
Phone  080-25532037  
Fax  080-25532037  
Email  a.kurpad@sjri.res.in  
 
Source of Monetary or Material Support  
Department of Biotechnology, New Delhi, India 
 
Primary Sponsor  
Name  Government of India Ministry of Science Technology Department of Biotechnology 
Address  Block 2 6-8th floors CGO complex Lodi Road New Delhi-110003 
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 Anura V Kurpad  Department of Obsterics and gynecology, St Johns Medical College Hospital  St. Johns Research Institute, Division of Nutrition, St John’s National Academy of Health Sciences, Sarjapur Road.
Bangalore
KARNATAKA 
080-25532037
080-25532037
a.kurpad@sjri.res.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Review Board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Pregnant women 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Milk protein with Cyanocobalamin  Group1 vitamin B12 (10ug/day) with Milk protein (500ml/day)will be supplemented from the end of 1st trimester (approx. 13 weeks)until delivery.  
Comparator Agent  Milk protein with placebo  Group2 will be receiving milk protein (500ml/day) with a placebo tablet from the end of 1st trimester (approx. 13 weeks)until delivery. 
Comparator Agent  Placebo (control)  Group3 will be receiving placebo tablet from the end of 1st trimester (approx. 13 weeks) until delivery. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  Pregnant women
Exclusion criteria include:
1) Women with multiple pregnancies
2) Pregnant women with pre-existing medical conditions such as diabetes, hypertension, metabolic disorders, epilepsy etc
3) Pregnant women on medications
4) Pregnant women anticipating to move out of the study site before completion of the study
5) Assisted pregnancy 
 
ExclusionCriteria 
Details  Excluded will be those mothers who anticipate moving out of the area before study completion, those with twin or multiple pregnancies, those who tested positive for hepatitis B (HBsAg), HIV or syphilis (VDRL) infections or those who are taking daily vitamin supplements in addition to folate and iron. Women with a serious pre-existing medical condition will be excluded, and these will be defined as conditions that require chronic or daily medical therapy. Examples include connective tissue diseases, hypertension not related to pregnancy, inflammatory bowel disease, active tuberculosis, symptomatic heart disease, and insulin-dependent diabetes 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Gestational weight gain   during pregnancy 
 
Secondary Outcome  
Outcome  TimePoints 
Methyl transfer kinetic at 3rd trimester and birth weight at Bangalore site.
Birth weight at Pune site.
 

during delivery 
 
Target Sample Size   Total Sample Size="180"
Sample Size from India="180" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   04/07/2011 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="3"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

The incidence of poor fetal growth (both low birth weight (LBW) and intrauterine growth retardation (IUGR)) is quite high in developing countries and in India. A number of surveys have confirmed a high rate of LBW, IUGR and other poor maternal and infant outcomes in India. World Health Organization (WHO) has also estimated a high incidence of ~ 28.3% LBW in South Central Asia. Since the majority of LBW infants in India and most developing countries are a result of IUGR, studies that explore the etiology of IUGR and interventions aimed at preventing fetal growth retardation are urgently needed. The cause of LBW is multi-factorial, and number of nutrient has critical roles in contributing to an optimal birth outcome. Along with various maternal parameters such as pre-pregnancy weight, gestational weight gain, morbidity during pregnancy and various pregnancy risk factors, nutrition plays an important role in determining birth outcomes.

In recent past studies have shown birth size to be strongly associated with antenatal consumption of green leafy vegetables and fruits. Similarly dairy and meat protein are also known to be related to birth weight, specifically milk intake during pregnancy. Results from our laboratory have shown that vitamin maternal B12 is also a strong determinant of IUGR. Since vitamin B12 is necessary for methyl group production, hence methylation reactions, it plays an important role in facilitating the reactions by incorporating and transferring the methyl groups through the methionine transmethylation pathway. The mechanism by which vitamin B12 deficiency may operate is thought to be through epigenetic phenomena relating to the lower methylation of key regions of the genome which can be examined in placental specimens. There is a need for studies that look for mechanisms relating to these observations above through rational but scalable intervention strategies. Some policy makers have prematurely called for the initiation of micronutrient supplementation in the absence of data that evaluate the (mechanistic) relationship between these potential micronutrient deficiencies and adverse pregnancy outcome. It is important to investigate the mechanisms involved in relationships of micronutrients and adverse birth outcomes as evidences from retrospective studies have shown an increased risk for chronic metabolic and cardiovascular disease in adulthood with an inverse relationship to birth weight. To take these findings forward into practice, carefully controlled intervention trials are needed, and there are no satisfactory data in the literature. Therefore we plan to study the effect of protein intake and protein with vitamin B12 intake during pregnancy and epigenetic mechanisms of vitamin B12 involved during pregnancy.

 
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