Background: Orofacial clefts (OFC) are linked with several genetic and environmental factors. The aim of this study was to explore the association of potential risk factors with OFCs in India. Methods: This was a hospital-based, matched case-control (1:4 ratio; matching done for parity) study conducted in Hyderabad, Bengaluru, and Delhi-National Capital Region. Cases (nonsyndromic clefts) were recruited from treatment centers, while controls (live births) were recruited from maternity centers. p value 5 0.001), and delayed first conception (AOR, 2.55, 95% CI, 1.25-5.21, p 5 0.01) were found to be strongly associated with higher risk of OFCs. Supplementation with folic acid during first 3 months of pregnancy was not found to be protective against OFCs (AOR, 1.24; 95% CI, 0.59-2.58; p value 5 0.56). Conclusion: Our study confirmed the importance of family history as a risk factor for OFC. Our study did not show an association with folic acid supplementation but was underpowered to detect small effects. Our finding of higher risk among vegetarians requires replication.
Background: Low folate and vitamin B12 levels have negative effect on pregnancy outcomes but there is paucity of data on their levels among Indian women. Ferritin and haemoglobin are associated with maternal mortality and low birth-weight. Our aim was to estimate the prevalence of deficiency of serum folate and vitamin B12, and low levels of serum ferritin and blood haemoglobin among women of childbearing age from a rural population of South India. Methods: We conducted a community-based cross-sectional study among 15-35 year women in a rural district. We used multistage stratified random sampling. Trained staff interviewed women to collect socio-demographic information and draw blood samples. We analysed samples for serum folate, vitamin B12, ferritin and blood haemoglobin levels and computed means and medians. We computed the proportion of deficiency based on cut-offs recommended by WHO. We examined the association of levels with age, parity and current pregnancy or breastfeeding by multi-variable regression using Stata 13.0. Results: We recruited 979 women. One-fifth (185, 19%) were pregnant and one-fifth (196, 20%)were breastfeeding. Median serum folate levels were 2.5 ng/ml (IQR, 1.2-4.8), median vitamin B12 levels were 228.0 pg/ml (IQR, 121 -390), median ferritin levels were 13.0 μg/l (IQR, 6.0 -20.0) and median blood haemoglobin levels were 12.1 mg/dl (IQR, 10.7 -13.6). Low levels of serum folate, vitamin B12, ferritin and haemoglobin were found in 57% (95% CI, 54-60%), 44% (95% CI, 41-48%), 46% (95% CI, 43-49%) and 28% (95% CI, 25-31%) respectively. Women with folic acid deficiency had two times higher prevalence of having vitamin B12 deficiency. In adjusted regression analysis folate levels were lower in older and breastfeeding women, but not associated with parity and were higher among pregnant women. Similar associations were not found with Vitamin B12 deficiency. Ferritin levels were higher in older women; but not associated with parity, pregnancy or breastfeeding. Haemoglobin levels were lower in pregnant and breastfeeding women. Conclusion: Our findings suggest that folic acid, vitamin B12 and iron deficiency are important public health problems in India. We observed that half of the women of childbearing age were deficient in these nutrients. Folic acid and vitamin B12 deficiencies co-exist and should be supplemented together.
Background Uncorrected refractive errors can be corrected by spectacles which improve visual functioning, academic performance and quality of life. However, spectacle wear can be low due to teasing/bullying, parental disapproval and no perceived benefit. Hypothesis: higher proportion of children with uncorrected refractive errors in the schools allocated to the intervention will wear their spectacles 3–4 months after they are dispensed. Methods A superiority, cluster-randomised controlled trial was undertaken in 50 government schools in Hyderabad, India using a superiority margin of 20%. Schools were the unit of randomization. Schools were randomized to intervention or a standard school programme. The same clinical procedures were followed in both arms and free spectacles were delivered to schools. Children 11–15 years with a presenting Snellen visual acuity of <6/9.5 in one or both eyes whose binocular acuity improved by ≥2 lines were recruited. In the intervention arm, classroom health education was delivered before vision screening using printed images which mimic the visual blur of uncorrected refractive error (PeekSim). Children requiring spectacles selected one image to give their parents who were also sent automated voice messages in the local language through Peek. The primary outcome was spectacle wear at 3–4 months, assessed by masked field workers at unannounced school visits. www.controlled-trials.com ISRCTN78134921 Registered on 29 June 2016 Findings 701 children were prescribed spectacles (intervention arm: 376, control arm: 325). 535/701 (80%) were assessed at 3–4 months: intervention arm: 291/352 (82.7%); standard arm: 244/314 (77.7%). Spectacle wear was 156/291 (53.6%) in the intervention arm and 129/244 (52.9%) in the standard arm, a difference of 0.7% (95% confidence interval (CI), -0.08, 0.09). amongst the 291 (78%) parents contacted, only 13.9% had received the child delivered PeekSim image, 70.3% received the voice messages and 97.2% understood them. Interpretation Spectacle wear was similar in both arms of the trial, one explanation being that health education for parents was not fully received. Health education messages to create behaviour change need to be targeted at the recipient and influencers in an appropriate, acceptable and accessible medium. Funding USAID (Childhood Blindness Programme), Seeing is Believing Innovation Fund and the Vision Impact Institute.
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.
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