HbE TraitHb VariantsNCT07305181
Prevalence of Abnormal Haemoglobin Variants in Metropolitan Chattogram, Bangladesh
An observational study of HbE Trait and Hemoglobinopathies, run by Bangladesh Bioscience Research Group at 1 site in Bangladesh.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 month to 70 years
- Conditions the study is for
- HbE Trait, Hemoglobinopathies
- How many people
- 8,400 participants
- Where
- 1 siteBangladesh
- Study dates
- 1 Jan 2021to 30 Sep 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population will comprise individuals residing within the metropolitan area who meet the predefined inclusion criteria. Eligible participants, irrespective of age or sex, will be considered for enrollment, ensuring representation across demographic groups. Participation will be strictly voluntary, and only those who provide informed consent (or assent with parental/guardian consent in the case of minors) will be included in the study. This approach is intended to capture a diverse and representative sample of the target community, thereby enhancing the generalizability and validity of the study findings.
Who may be able to join
- Residents of the selected metropolitan area.
- All ages (1 Month - 70 Years) and both sexes.
- Willing to provide informed consent.
Who cannot join
- Refusal to provide informed consent.
- Inaccurate data.
Trial locations and contacts
1 site in 1 country.
Bangladesh1 site
University of Science and Technology Chittagong (USTC)
Khulshi, Chattogram, 4203
About this study
Official title: Screening and Identifying Abnormal Haemoglobin Fractions in a Metropolitan Area in Chattogram
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.
Read the detailed description
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.
- Conditions
- HbE Trait, Hemoglobinopathies
- Keywords
- HbE Disease, Thalassemia, Sickle cell disease
- Medical subject headings
- Hemoglobinopathies, Thalassemia, Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| No Intervention (Diagnostic Test Only) | Biochemical Test and detect hemoglobin variants (HPLC, CE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of abnormal haemoglobin fractions in Chattogram
The proportion of participants identified with abnormal haemoglobin fractions.
Measured: Day 01, at enrolment
Secondary outcomes (1)
Different spectrum of haemoglobin variants
The identification and frequency distribution of specific haemoglobin variants (e.g., HbE, HbS) within the study population.
Measured: Day 01, on enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start1 Jan 2021
- Primary completion30 Jun 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HbE TraitStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 8,400 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Bangladesh Bioscience Research Group
- Sponsor type
- Research network
- Collaborators
- Chattogram International Dental College, Chittagong Medical College and Hospital, Bangladesh Medical University
- Responsible party
- Principal investigator, Pair Ahmed Jiko, MS; MPH, Bangladesh Medical Research Council (BMRC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07305181
- Sponsor's protocol ID
- BBMH/2021/RP-2330
- Acronym
- Hb Variants
- Status last verified
- Oct 2025
- First submitted
- 12 Dec 2025
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data (IPD) will not be shared with other researchers to protect patient confidentiality and comply with institutional and ethical guidelines. Only aggregated, de-identified data may be shared upon reasonable request and with appropriate ethical approvals.
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening and Identifying Abnormal Haemoglobin Fractions in a Metropolitan Area in Chattogram
- ClinicalTrials.gov ID
- NCT07305181
- Acronym / sponsor ID
- Hb Variants / BBMH/2021/RP-2330
- Conditions
- HbE Trait, Hemoglobinopathies
- Keywords
- HbE Disease, Thalassemia, Sickle cell disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8,400 participants (actual)
- Lead sponsor
- Bangladesh Bioscience Research GroupResearch network
- Collaborators
- Chattogram International Dental College, Chittagong Medical College and Hospital, Bangladesh Medical University
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 26 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No Intervention (Diagnostic Test Only) | – | –Biochemical Test and detect hemoglobin variants (HPLC, CE) |
Who may qualify
- Ages
- 1 month to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will comprise individuals residing within the metropolitan area who meet the predefined inclusion criteria. Eligible participants, irrespective of age or sex, will be considered for enrollment, ensuring representation across demographic groups. Participation will be strictly voluntary, and only those who provide informed consent (or assent with parental/guardian consent in the case of minors) will be included in the study. This approach is intended to capture a diverse and representative sample of the target community, thereby enhancing the generalizability and validity of the study findings.
Key inclusion criteria (3 listed)
- Residents of the selected metropolitan area.
- All ages (1 Month - 70 Years) and both sexes.
- Willing to provide informed consent.
Key exclusion criteria (2 listed)
- Refusal to provide informed consent.
- Inaccurate data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of abnormal haemoglobin fractions in Chattogram
Time frame: Day 01, at enrolment
The proportion of participants identified with abnormal haemoglobin fractions.
1 secondary outcome
Different spectrum of haemoglobin variants
Time frame: Day 01, on enrolment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Individual participant dataSharing planned: No. Individual Participant Data (IPD) will not be shared with other researchers to protect patient confidentiality and comply with institutional and ethical guidelines. Only aggregated, de-identified data may be shared upon reasonable request and with appropriate ethical approvals.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HbE Trait and Hemoglobinopathies, run by Bangladesh Bioscience Research Group at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of abnormal haemoglobin fractions in Chattogram (time frame: Day 01, at enrolment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.