Vitamin B12 during pregnancy

Completed

Conditions: Pregnant women

Registration Number: CTRI/2016/01/006578

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

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 180

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gestational weight gain	during pregnancy

Secondary Outcome Measures

Name	Time	Method
Methyl transfer kinetic at 3rd trimester and birth weight at Bangalore site.	Birth weight at Pune site.

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
Dr Anura V Kurpad
Principal investigator
080-25532037
a.kurpad@sjri.res.in