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CTRI Number  CTRI/2018/03/012570 [Registered on: 15/03/2018] Trial Registered Retrospectively
Last Modified On: 13/03/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Milk supplement]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of maternal nutritional on low birth weight 
Scientific Title of Study   The effect of a balanced energy protein milk supplement on arginine and methionine kinetics and birth weight outcomes in low BMI pregnant women 
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  Prof & Head Division of Nutrition Department of physiology 
Affiliation  St Johns Research Institute & Medical College 
Address  St Johns National Academy of Health Sciences Sarjapura Road

Bangalore
KARNATAKA
560034
India 
Phone  910849466349  
Fax    
Email  a.kurpad@sjri.res.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Pratibha Dwarkanath 
Designation  Assistant Prof Division of Nutrition 
Affiliation  St Johns Research Institute 
Address  St Johns National Academy of Health Sciences Sarjapura Road

Bangalore
KARNATAKA
560034
India 
Phone  910849466326  
Fax    
Email  pratibha@sjri.res.in  
 
Details of Contact Person
Public Query
 
Name  Dr Pratibha Dwarkanath 
Designation  Assistant Prof Division of Nutrition 
Affiliation  St Johns Research Institute 
Address  St Johns National Academy of Health Sciences Sarjapura Road

Bangalore
KARNATAKA
560034
India 
Phone  910849466326  
Fax    
Email  pratibha@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-11000 
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 
Prof Anura V Kurpad  Department of Obsterics and gynecology, St Johns Medical College Hospital  Division of Nutrition, R No 414, St. Johns Research Institute,St John’s National Academy of Health Sciences, Sarjapur Road
Bangalore
KARNATAKA 
910849466349

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 
Comparator Agent  Control group  Group 2 consume habitual diet with Counseling from the end of 1st trimester (approx. 13 weeks)until delivery 
Intervention  Milk supplement  Group 1 to receive Milk supplement (500ml/day)and counseling from the end of 1st trimester (approx. 13 weeks)until delivery 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Apparent healthy pregnant women, 18-40 years old, recruited early in 1st trimester pregnancy
 
 
ExclusionCriteria 
Details  Subjects > 13 weeks of gestation at recruitment, Subject with twin or multiple pregnancies, Pregnant women with chronic morbidity or on long term medications or positivity for hepatitis B (HBsAg), HIV or syphilis (VDRL) infections, Subjects anticipating moving out of study site for delivery, Pregnant women not willing to participate in the infusion protocol
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Measurement and comparison of methionine and arginine kinetics in the 1st and 3rd trimester of pregnancy among the 2 groups of pregnant women  during pregnancy 
 
Secondary Outcome  
Outcome  TimePoints 
gestational weight gain
birth weight 
during pregnancy
at birth 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   07/04/2014 
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="4"
Months="2"
Days="23" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   The manuscript will be entitled as, Characterization of methionine and arginine kinetics among low BMI pregnant women supplemented with balanced energy and protein milk supplement. However as the analysis is ongoing, there are no publications yet. 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Low birth weight may be linked to inadequate protein and vitamin B12 in the 2nd and 3rd trimesters of pregnancy.  There are epidemiological associations that have been noted for these deficiencies during pregnancy, but they have not been tested.  It is also thought that supplementing methionine and vitamin B12 would be beneficial to methionine kinetics and in consequence, favourably changing the epigenome of babies, with a view to preventing later chronic disease in adulthood.  Earlier studies have shown that methionine and arginine kinetics are low in Indian pregnant women.  This is particularly relevant with the thrust being given to the adequate and appropriate feeding of pregnant women in India.  To test the hypothesis that supplementation of protein and vitamin b12 during pregnancy could improve biochemical fluxes, placental epigenetics and birth outcomes, an intervention trial with a daily supplement of 500 ml of skimmed milk during pregnancy was performed in low BMI pregnant Indian women. Methionine and arginine kinetics were measured at the end of 1st trimester and in 3rd trimester, as well as birth outcomes and placental characteristics. The study findings will help in filling gaps in our knowledge about the relationship between nutritional status of pregnant women and maternal and child health outcomes. The novelty of this study is the use of stable isotope tracers that measures fluxes of amino acids, since we have earlier shown that arginine and methionine are deficient during pregnancy. 

 
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