Abstract
BackgroundEvidence from high income countries shows mothers who are supplemented with folic acid in their periconceptional period and early pregnancy have significantly reduced adverse outcomes like birth defects. However, in India there is a paucity of data on association of birth defects and folic acid supplementation. We identified a few important questions to be answered using separate scientific methods and then planned to triangulate the information.ObjectiveIn this paper, we describe the protocol of our study that aims to determine the association of folic acid and pregnancy outcomes like neural tube defects (NTDs) and orofacial clefts (OFCs). We decided to fill the gaps in knowledge from India to determine public health consequences of folic acid deficiency and factors influencing dietary and periconceptional consumption of folic acid.MethodsThe proposed study will be carried out in five stages and will examine the questions related to folic acid deficiency across selected locations in South and North India. The study will be carried out over a period of 4 years through the hierarchical evidence-based approach. At first a systematic review was conducted to pool the current birth prevalence of NTDs and orofacial clefts OFCs in India. To investigate the population prevalence, we plan to use the key informant method to determine prevalence of NTDs and OFCs. To determine the normal serum estimates of folic acid, iron, and vitamin B12 among Indian women (15-35 years), we will conduct a population-based, cross-sectional study. We will further strengthen the evidence of association between OFCs and folic acid by conducting a hospital-based, case-control study across three locations of India. Lastly, using qualitative methods we will understand community and health workers perspective on factors that decide the intake of folic acid supplements.ResultsThis study will provide evidence on the community prevalence of birth defects and prevalence folic acid and vitamin B12 deficiency in the community. The case-control study will help understand the association of folic acid deficiency with OFCs.ConclusionsThe results from this study are intended to strengthen the evidence base in childhood disability for planning and policy initiatives.
Highlights
BackgroundFolic acid is a micronutrient with a vital role during human reproduction and in a variety of physiological processes [1,2]
We will further strengthen the evidence of association between orofacial clefts (OFCs) and folic acid by conducting a hospital-based, case-control study across three locations of India
The case-control study will help understand the association of folic acid deficiency with OFCs
Summary
BackgroundFolic acid is a micronutrient with a vital role during human reproduction and in a variety of physiological processes [1,2]. Evidence from some countries shows that mothers who are supplemented with folic acid in their periconceptional period and early pregnancy have significantly reduced adverse outcomes compared with mothers who are not supplemented [6]. In India, the current under-5 child mortality is estimated to be 48 per 1000 live births, a little over the set target [8] This decline is attributed to a fall in the number of deaths from infectious diseases and malnutrition; while the mortality attributed to birth defects remains constant [9]. Evidence from high income countries shows mothers who are supplemented with folic acid in their periconceptional period and early pregnancy have significantly reduced adverse outcomes like birth defects. We identified a few important questions to be answered using separate scientific methods and planned to triangulate the information
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