Murthy Gudlavalleti Venkata S, Kolli Sunanda Reddy, Neogi Sutapa B, Singh Samiksha, Allagh Komal Preet, John Neena, N Srinivas, Ramani Sudha, Shamanna B R, Doyle Pat, Kinra Sanjay, Ness Andy, Pallepogula Dinesh Raj, Pant Hira B, Babbar Smiksha, Reddy Raghunath, Singh Rachna
Indian Institute of Public Health, Hyderabad, India.
JMIR Res Protoc. 2016 Jun 23;5(2):e129. doi: 10.2196/resprot.5722.
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. 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.
In 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.
The 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.
This 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.
The results from this study are intended to strengthen the evidence base in childhood disability for planning and policy initiatives.
高收入国家的证据表明，在围孕期和孕早期补充叶酸的母亲出现出生缺陷等不良后果的几率显著降低。然而，在印度，关于出生缺陷与叶酸补充之间关联的数据却很匮乏。我们确定了一些重要问题，打算运用不同的科学方法予以解答，然后对信息进行整合分析。
在本文中，我们描述了一项研究方案，旨在确定叶酸与神经管缺陷（NTDs）和口面部裂隙（OFCs）等妊娠结局之间的关联。我们决定填补印度在这方面的知识空白，以确定叶酸缺乏对公共卫生的影响以及影响叶酸膳食摄入和围孕期摄入的因素。
拟开展的这项研究将分五个阶段进行，在印度南部和北部的选定地点研究与叶酸缺乏相关的问题。该研究将通过基于证据的分层方法，在4年时间内完成。首先进行了一项系统综述，汇总印度目前神经管缺陷和口面部裂隙的出生患病率。为调查人群患病率，我们计划采用关键信息提供者法来确定神经管缺陷和口面部裂隙的患病率。为确定印度15至35岁女性叶酸、铁和维生素B12的正常血清水平，我们将开展一项基于人群的横断面研究。我们还将在印度三个地点开展一项基于医院的病例对照研究，以进一步强化口面部裂隙与叶酸之间关联的证据。最后，我们将采用定性方法，了解社区和卫生工作者对决定叶酸补充剂摄入因素的看法。
本研究将提供关于社区出生缺陷患病率以及社区叶酸和维生素B12缺乏患病率的证据。病例对照研究将有助于了解叶酸缺乏与口面部裂隙之间的关联。
本研究结果旨在加强儿童残疾领域规划和政策举措的证据基础。
