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202                       Gupta et al. | Journal of Clinical and Translational Research 2024; 10(3): 201-208
        sources that significantly contribute to lead exposure: gasoline   was approximately 30 km from the All India Institute of Medical
        additives; food can solder; lead-based paints; ceramic glazes;   Sciences (AIIMS), Mangalagiri. The study was conducted in 2022
        drinking water systems; and cosmetic  and folk remedies  [2].   among adult males and females from 20 to 60 years of age. The
        Other  significant  exposures  include  inadequately  controlled   study participants were divided accordingly into three groups:
        industrial emissions from lead smelters and battery recycling   (i)  Group 1: Direct occupationally exposed individuals, such
        plants, contaminating both the environment and people in the   as workers in  lead  battery  manufacturing,  construction
        vicinity [2]. The highest level of environmental contamination   workers, demolition workers, gas station attendants, lead
        is found to be associated with uncontrolled recycling operations,   smelters, smolderers, and painters.
        with the most highly exposed adults being those who work with   (ii)  Group 2: Indirect air pollution-exposed individuals, such as
        lead [3].                                                 traffic police, police, truck drivers, bus drivers, auto drivers,
          In India and most developing countries, the main source of   and petrol bunk workers.
        lead pollution was previously automobile exhaust. With the use   (iii) Group 3: Indirect non-occupationally exposed individuals,
        of unleaded petrol, lead pollution due to automobile exhaust   such as indoor officer workers, teachers, primary health-
        has drastically dropped [4]. Approximately 143,000 people die   care workers, and housewives.
        annually from lead poisoning, accounting for 0.6% of the global
        disease burden [5], and Southeast Asia accounts for over half of   Individuals were eligible for participation in Groups 1 and
        the global burden of lead-related illness. Greater blood lead levels   2 after working in the same occupation for at least 6 months
        (BLL) are linked to increased all-cause mortality in both men and   or in Group 3 after residing in the area or working in the same
        women with cardiovascular diseases. Although the World Health   occupation for the past 6 months. Individuals with symptoms
        Organization (WHO) has set a standard BLL of 5  µg/dL for   suggestive  of critical  illness,  diabetes  mellitus,  hypertension,
        adults [1], the Environmental Health Committee of the Council   recently underwent surgery, and those who denied consent were
        of State and Territorial Epidemiologists (CSTE) indicated that a   excluded from the study.
        blood lead reference value (BLRV) >3.5 µg/dL is considered high.   The  sample  size was calculated using the  sample  formula
        BLRV is used to identify patients with the highest BLL in the   required per group:
        population but is not indicative of a toxicity threshold [6]. Adult   [Z   +  Z   ] 2
        lead toxicity is typically considered at mean BLL ≥10 µg/dL, but   n  (σ =  1 2  σ +  2 2 ) ×  1 @/2−  1−  β  (I)
        there is evidence linking long-term risks to chronic lead exposure     (M − M ) 2
                                                                                  1
                                                                                      2
        below 10 µg/dL [7]. Other studies indicate a correlation between
        higher BLLs and increased cardiovascular mortality in adults [8].   Where σ denotes the standard deviation (SD) of the outcome
                                                                        1
        Lead is a strong inhibitor of δ-aminolevulinic acid dehydratase,   variable in Group 1 σ denotes the SD of the outcome variable
                                                                                 2
                                                                               ,
        affecting the spleen and hematopoietic system [9].     in Group 2, Z 1-@/2  and Z  denote the probability of two types
                                                                                   1-β
          According  to  evidence  on  the  long-term  effects  of  low-  of errors at 1.96 and 1.282, respectively, and M M denotes
                                                                                                          2
                                                                                                       1 -
        level lead exposures and the prevalence of lower levels in the   the mean difference between groups The means of continuous
                                                                                            .
        population, the United States (US) Department of Health and   variables were compared using a t-test. We utilized the findings
        Human Services advises reducing BLLs among all individuals   from two previous studies as Groups 1 and 2 to determine the
        to <10 µg/dL [7,10,11]. It is widely recognized that the lead   sample size. Group 1 included workers handling raw material
        exposure standard set by the US  Occupational  Health and   in a battery factory in Nellore, Andhra Pradesh, with a mean
        Safety Administration is outdated and does not provide adequate   ±  2SD BLL (µg/dL)  of  26.2 ±  2.142 in  2016 – 2017  [3].
        protection against lead poisoning [10,12]. This standard permits   Group  2 included  non-occupationally  lead-exposed  healthy
        workers to  continue  working in  lead-exposed  environments   school teachers from various public and government sectors,
        with BLLs of up to 40 µg/dL.                           representing various nodal areas of Jodhpur with a mean ± 2SD
          Developed countries, such as the US, United Kingdom, and   BLL (µg/dL) of 6.89 ± 9.5 [13]. Utilizing a 95% confidence
        Germany, have implemented  aggressive measures to address   interval (CI) and 90% power, we calculated the required sample
        lead poisoning while developing countries present slower and   size to detect a 3.0 µg/dL difference in BLLs in any two groups
        more sporadic actions. Within the past decade, there have been   to be 60. Hence, the total sample studied was 180, excluding
        numerous reports of lead poisoning in humans, particularly from   nonresponse and attrition.
        developing countries faced with environmental and occupational   After ascertaining the eligibility of the participant, detailed
        lead exposure [4]. The present study was conducted to estimate   information about the study was provided through the Participant
        and compare BLLs in the adult population  with and without   Information Sheet and consent document. Both these documents
        occupational lead exposure.                            were in Telugu, and any difficult words were explained with the
                                                               assistance of a local interpreter. Data collection was conducted
        2. Methods                                             once written consent was accorded. The project was approved

        2.1. Study design                                      by the ethical committee of the AIIMS Institute (AIIMS/MG/
                                                               IEC/2022-2023/135).
          A baseline survey of the prospective cohort study was   Investigators were trained in data collection, blood collection,
        conducted in the Guntur district, Andhra Pradesh, India, which   and transportation. A pilot survey was conducted and corrective

                                              DOI: https://doi.org/10.36922/jctr.23.00130
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