NCT07305181

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8,400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 12, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 26, 2025

Completed
Last Updated

December 26, 2025

Status Verified

October 1, 2025

Enrollment Period

4.5 years

First QC Date

December 12, 2025

Last Update Submit

December 12, 2025

Conditions

Keywords

HbE DiseaseThalassemiaSickle cell disease

Outcome Measures

Primary Outcomes (1)

  • Prevalence of abnormal haemoglobin fractions in Chattogram

    The proportion of participants identified with abnormal haemoglobin fractions.

    Day 01, at enrolment

Secondary Outcomes (1)

  • Different spectrum of haemoglobin variants

    Day 01, on enrolment

Study Arms (1)

No Intervention (Diagnostic Test Only)

Biochemical Test and detect hemoglobin variants (HPLC, CE)

Eligibility Criteria

Age1 Month - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

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

You may not qualify if:

  • Refusal to provide informed consent.
  • Inaccurate data.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Science and Technology Chittagong (USTC)

Khulshi, Chattogram, 4203, Bangladesh

Location

MeSH Terms

Conditions

HemoglobinopathiesThalassemiaAnemia, Sickle Cell

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesAnemia, Hemolytic, CongenitalAnemia, HemolyticAnemia

Study Design

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

Study Record Dates

First Submitted

December 12, 2025

First Posted

December 26, 2025

Study Start

January 1, 2021

Primary Completion

June 30, 2025

Study Completion

September 30, 2025

Last Updated

December 26, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

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.

Locations