NCT03121027

Brief Summary

Despite significant advances in the field of medicine and healthcare, anemia continues to be a major public health problem worldwide. The situation is particularly acute in developing countries where females belonging to the reproductive age category are especially vulnerable to the malady. Given the multifactorial nature of this disease, correcting anemia often requires the adoption of an integrated approach. Therefore, it is imperative that the role played by the "causes of the causes" (i.e., the sociodemographic determinants of risk), along with other contributing factors, must be identified, and addressed in order to effectively combat this disease. In general, it is terrible to sort out the psychosocial factors from the demographics, environmental and poverty-related causes. Therefore, the objective of this study is to use a nationwide representative survey to explore the magnitude of household economic inequalities contribute towards the prevalence of anemia among ever-married women in Bangladesh. The study also aims to examine the inference of other explanatory variables that frequently had supposed decomposing on the burden of anemia. Thus, this study answers the questions: (a) what are the strengths and likelihoods of having mild, moderate or severe anemia among the ever married women of different SES?; (b) do other factors viz., demographics, diabetes, maternity, and BMI affects the strength and form of the association between SES and anemia?; (c) which explanatory variable is more prone to pose anemia among the women? As the burden of anemia is one of the key policy issues facing Bangladesh, the findings generated by this study are expected to contribute towards further policy making by virtue of identifying associated risk factors. This is expected to be instrumental for program purposes designed to prevent anemia among Bangladeshi women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5,920

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2011

Shorter than P25 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

May 11, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 8, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2012

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

April 11, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 19, 2017

Completed
Last Updated

April 19, 2017

Status Verified

April 1, 2017

Enrollment Period

2 months

First QC Date

April 11, 2017

Last Update Submit

April 14, 2017

Conditions

Keywords

AnemiaEver married womenEconomic inequalityDiabetesMaternityBMI

Outcome Measures

Primary Outcomes (1)

  • Anemia

    Hemoglobin concentration will be used as the parameter for diagnosing anemia. For the purpose of this study, "anemia" will be defined as per WHO, 2011 guidelines for the diagnosis of anemia. Briefly, in the case of pregnant women, a hemoglobin concentration of less than 70 g/L will be used to define severe anemia, between 70-99.99 g/L will be used for defining moderate anemia while 100-109.99 g/L will be consider to correspond to mild anemia (n=372). In non-pregnant women, a hemoglobin concentration of less than 80 g/L will be used to define severe anemia, 80-109.99 g/L for moderate anemia, and 110-119.99 g/L to correspond to mild anemia. In accordance with the recommendation of the Center for Disease Prevention of United States, and in agreement with the World Health Organization, the blood assay report for anemia will be adjusted for altitude and smoking during the categorization into "severe" "moderate" or "mild" anemia.

    Baseline

Eligibility Criteria

Age15 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Ever married Women in Bangladesh

You may qualify if:

  • Ever-married women: Those who get married, divorced and the widow is also included.

You may not qualify if:

  • Not married women: Those who never married.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Data analysis

Sylhet, 3114, Bangladesh

Location

MeSH Terms

Conditions

AnemiaDiabetes Mellitus

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • GM R. Islam, PhD

    Shahjalal University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 11, 2017

First Posted

April 19, 2017

Study Start

May 11, 2011

Primary Completion

July 8, 2011

Study Completion

January 18, 2012

Last Updated

April 19, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Available IPD Datasets

Individual Participant Data Set Access

Locations