Effect of maternal nutritional on low birth weight

Active, not recruiting

Conditions: Pregnant women

Registration Number: CTRI/2018/03/012570

Lead Sponsor: Government of India Ministry of Science Technology Department of Biotechnology

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Closed to Recruitment of Participants

Sex: Female

Target Recruitment: 60

Inclusion Criteria

Apparent healthy pregnant women, 18-40 years old, recruited early in 1st trimester pregnancy.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
gestational weight gain	birth weight

Trial Locations

Locations (1): Department of Obsterics and gynecology, St Johns Medical College Hospital
🇮🇳
Bangalore, KARNATAKA, India
Department of Obsterics and gynecology, St Johns Medical College Hospital
🇮🇳Bangalore, KARNATAKA, India
Prof Anura V Kurpad
Principal investigator
910849466349
a.kurpad@sjri.res.in