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临床试验/NCT07305181
NCT07305181已完成不适用

Screening and Identifying Abnormal Haemoglobin Fractions in a Metropolitan Area in Chattogram

Bangladesh Bioscience Research Group1 个研究点 分布在 1 个国家目标入组 8,400 人开始时间: 2021年1月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
8,400
试验地点
1
主要终点
Prevalence of abnormal haemoglobin fractions in Chattogram

研究概览

简要总结

Hemoglobinopathies are inherited disorders that affect haemoglobin and pose a considerable global health challenge. This research addresses the knowledge gap regarding the prevalence of a typical haemoglobin fraction within urban populations by testing the HbA1c test in capillary electrophoresis. Participants will be recruited with careful ethical considerations and informed consent will be obtained. The screening will utilize laboratory techniques to detect abnormal haemoglobin fractions through testing. Statistical methods will be used for data analysis to assess prevalence rates and pinpoint specific haemoglobin variants while considering demographic factors. The project's milestones include planning the study, collecting data (from January 2021 to June 2025), conducting analyses, preparing reports and sharing the findings.

详细描述

This study is designed as a cross-sectional observational study aimed at detecting and identifying abnormal haemoglobin variants associated with genetic blood disorders, particularly Alpha-thalassemia, Beta-thalassemia, and Sickle Cell Disease, within an urban population. Hemoglobinopathies are among the most prevalent inherited disorders worldwide, yet there remains limited data on their frequency and distribution in metropolitan areas such as Chattogram, Bangladesh, where genetic diversity, lifestyle factors and high population density may influence disease patterns. The rationale behind this study is to provide much-needed baseline epidemiological information that will facilitate early detection, effective prevention strategies and improved clinical management of these conditions.

The primary objective is to identify abnormal haemoglobin types. In contrast, secondary objectives include determining the prevalence of variants, analyzing demographic and lifestyle associations such as age, sex, socioeconomic background and ethnicity and raising community awareness about the importance of genetic carrier screening. The study population will include individuals aged 1 month to seventy years who have been city residents for at least five years and who provide informed consent. Exclusions will apply to individuals requiring emergency care, those already under treatment for known hemoglobinopathies and those unwilling to participate.

The methodology involves stratified random sampling to ensure the study population is representative. Demographic and clinical data such as family history, anaemia, jaundice and history of transfusions will be collected using a structured questionnaire. Venous blood samples (3 mL in EDTA) will be collected from participants and subjected to laboratory investigations. Initial screening will include Complete Blood Count (CBC) and red cell indices such as MCV, MCH and RDW. At the same time, confirmatory testing will be performed using haemoglobin electrophoresis and high-performance liquid chromatography (HPLC) and Capillary Electrophoresis (CE) to quantify and characterize abnormal haemoglobin variants. All results will be entered into a secure, coded database with strict quality control procedures. Statistical analysis will be conducted using SPSS to determine prevalence, distribution and associations between demographic or lifestyle factors.

The expected outcomes include reliable prevalence data of hemoglobinopathies in the selected population, the proportion of carriers versus affected individuals, and correlations with demographic determinants. These findings will guide future diagnostic strategies, inform genetic counselling programs and strengthen targeted public health interventions. Ethical approval will be obtained from the Institutional Review Board and informed consent will be secured from all participants or guardians in the case of minors. Confidentiality will be maintained throughout and individuals with abnormal results will be referred for clinical management and counselling.

Overall, this study will significantly enhance diagnostic awareness, shape health policy and contribute to prevention strategies through community-level interventions. Despite inherent limitations such as its cross-sectional design, potential recall bias in family history reporting and limited access to advanced molecular testing, the study is expected to provide critical insights into the burden of hemoglobinopathies in an urban Bangladeshi population.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
1 Month 至 70 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Residents of the selected metropolitan area.
  • All ages (1 Month - 70 Years) and both sexes.
  • Willing to provide informed consent.

排除标准

  • Refusal to provide informed consent.
  • Inaccurate data.

结局指标

主要结局

Prevalence of abnormal haemoglobin fractions in Chattogram

时间窗: Day 01, at enrolment

The proportion of participants identified with abnormal haemoglobin fractions.

次要结局

  • Different spectrum of haemoglobin variants(Day 01, on enrolment)

研究者

发起方
Bangladesh Bioscience Research Group
申办方类型
Network
责任方
Principal Investigator
主要研究者

Pair Ahmed Jiko, MS; MPH

Lab-Incharge (Biochemist)

Bangladesh Medical Research Council (BMRC)

研究点 (1)

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