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
|
|
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
|
|
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. |