Prevalence of Hemoglobinopathies Associated With Significant Hb Variants in the Chattogram Region of Bangladesh

NCT07207551 | Completed DMC

• 2 other identifiers: BBMH/2024/RP-2412BBMH/January/2024/024
• Study Type: observational
• Target: 760
• Locations: 1 country
• Sites: 1

Brief Summary

Hemoglobinopathies represent a collection of genetic conditions that influence the structure or synthesis of haemoglobin, the protein found in red blood cells that facilitates oxygen transport from the lungs throughout the body. This research proposal presents a study evaluating the prevalence of hemoglobinopathies and their significant haemoglobin variants within a specific population. The research will employ a cross-sectional study design, recruiting participants through community outreach efforts and healthcare facilities while obtaining informed consent. Data will be collected with the utmost precision and rigor, using advanced screening techniques such as high-performance liquid chromatography (HPLC), capillary electrophoresis, and molecular analysis. The gathered data will be processed to assess haematological parameters, including RBC, Iron Ferritin, TIBC, electrophoresis profiles (HbA, HbA2, HbE, HbF), MCV, MCHC, and PCV among individuals with hemoglobinopathies (HbE disease/trait, Beta thalassemia disease/trait, heterozygous HPFH, HbE-beta thal). They will examine variations relative to demographic factors. The expected results will have substantial clinical and public health consequences by enhancing genetic counselling, informing clinical decision-making, and strengthening public health initiatives.

Conditions

Hemoglobinopathies

Keywords

Hb Variants; HbE Trait; Beta Thalassemia; Iron Profile; Peripheral Blood Film (PBF)

Outcome Measures

Primary Outcomes (1)

• Detection of Hemoglobin Variants by Hb-Electrophoresis

  Performed to detect hemoglobin variants (e.g., HbA, HbE, HbS, HbC, HbD, HbF). The outcome will report the number and percentage of participants with each variant.

  Day 1, at enrollment

Secondary Outcomes (1)

• Correlation of Hematological Parameters with Demographic Factors

  Day 1, upon enrollment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Population will consist of individuals from the selected community and healthcare facilities who meet the inclusion criteria. Participants of all ages and both sexes will be included, provided they give informed consent and have not received a blood transfusion within the last three months. The population is expected to represent a cross-section of healthy individuals and those with suspected or confirmed hemoglobinopathies, allowing for assessment of hemoglobin variants and related biochemical parameters.

You may qualify if:

• Residents of the Chattogram metropolitan area.
• All ages and both sexes with informed consent.
• Willing to provide venous blood samples.
• No blood transfusion in the past 3 months.

You may not qualify if:

• Refusal or withdrawal of consent.
• Blood transfusion within the last 3 months.
• Pregnant women.
• Inadequate or hemolyzed blood samples.

Sponsors & Collaborators

• Bangladesh Bioscience Research Group: lead

Study Sites (1)

University of Science and Technology Chittagong (USTC)

Khulshi, Chattogram, 4203, Bangladesh

Location

MeSH Terms

Conditions

Hemoglobinopathies; beta-Thalassemia

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Thalassemia; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia

Study Officials

• PAIR AHMED JIKO, Lab-Incharge (Biochemist)

  Institute Of Applied Health Sciences Hospital-USTC (Ex-BBMH)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lab-Incharge (Biochemist)

Study Record Dates

• First Submitted: September 14, 2025
• First Posted: October 6, 2025
• Study Start: June 1, 2023
• Primary Completion: June 17, 2025
• Study Completion: September 4, 2025
• Last Updated: October 6, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)