AnemiaNCT03121027
Burden of Anemia Among Ever-married Women in Bangladesh: Does Household Economic Inequality Matter?
An observational study of Anemia, run by Shahjalal University of Science and Technology at 1 site in Bangladesh.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anemia
- How many people
- 5,920 participants
- Where
- 1 siteBangladesh
- Study dates
- 11 May 2011to 18 Jan 2012
- 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 15 to 49 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Ever married Women in Bangladesh
Who may be able to join
- Ever-married women: Those who get married, divorced and the widow is also included.
Who cannot join
- Not married women: Those who never married.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Burden of Anemia Among Ever-married Women in Bangladesh
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.
Read the detailed description
This study was carried out with the approval of ICF International ( Address: 11785 Beltsville Drive Suite 300 Calverton, MD 20705 USA). The data from the 2011 Bangladesh Demographic and Health Survey (BDHS), conducted under the authority of the National Institute of Population Research and Training (NIPORT) of the Ministry of Health and Family Welfare of Bangladesh will be used for this study. Mitra and Associates, a Bangladeshi research firm located in Dhaka implemented the survey and ICF International of Calverton, Maryland, USA, arranged the technical support to the mission as the part of its international Demographic and Health Surveys database (MEASURE DHS). Procedures and questionnaires for standard DHS surveys have been reviewed and approved by the ICF International Institutional Review Board (IRB). (See more at: http://www.dhsprogram.com/What-We-Do/Protecting-the-Privacy-of-DHS-Survey-Respondents.cfm#sthash.qc30dbXO.dpuf) The data collection processes for the BDHS was executed as per the approval of the ORC Macro-institutional review board. The survey protocol was reviewed and approved by the National Ethics Review Committee of the Bangladesh Ministry of Health and Family Welfare. As per BDHS guidelines, informed consent was obtained from all respondents before starting the interview along with an oral clarification offered by the interviewers themselves. Respondents were well informed with regards to the intended use of the gathered data (assessment of health needs and planning health services), the voluntary nature of the study, potential risks of participation in the study, the confidentiality of answers/results of the individual interview and biomarker assay, and that the examination was free of cost. Prior to the blood collection and examination, participants were also well informed about the purpose of the study.
A stratified, multistage cluster sampling strategy was followed in order to construct a national representative household-based sample. To generate this, 600 primary sampling units (207 from urban areas and 393 from rural areas) were raised from the sampling frame created for the 2011 Bangladeshi census. From each primary sampling unit, households were nominated randomly and 17,964 households were selected for interview. Face-to-face interviews were effectively completed among 17,141 selected households. Finally, in these households a total of 18,222 ever married women age 12-49 were identified and 17,842 were interviewed successfully. A total of 5920 ever-married women aged between 15-49 years who resided in one-third of the randomly selected households were selected as subjects for the biomarker assay for anemia study.
- Conditions
- Anemia
- Keywords
- Anemia, Ever married women, Economic inequality, Diabetes, Maternity, BMI
- Medical subject headings
- Anemia, Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2017
- Study start11 May 2011
- Primary completion8 Jul 2011
- Study completion18 Jan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 5,920 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahjalal University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, G.M. Rabiul Islam, Shahjalal University of Science and Technology
- Investigators
- GM R. Islam, PhD, Principal investigator, Shahjalal University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03121027
- Sponsor's protocol ID
- AW-FET
- Status last verified
- Apr 2017
- First submitted
- 11 Apr 2017
- Last updated
- 19 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Burden of Anemia Among Ever-married Women in Bangladesh
- ClinicalTrials.gov ID
- NCT03121027
- Acronym / sponsor ID
- AW-FET
- Conditions
- Anemia
- Keywords
- Anemia, Ever married women, Economic inequality, Diabetes, Maternity, BMI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,920 participants (actual)
- Lead sponsor
- Shahjalal University of Science and TechnologyUniversity, hospital or other
- Study start
- 11 May 2011 (actual)
- Primary completion
- 8 Jul 2011 (actual)
- Study completion
- 18 Jan 2012 (actual)
- First posted
- 19 Apr 2017 (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.
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.
Detailed description
This study was carried out with the approval of ICF International ( Address: 11785 Beltsville Drive Suite 300 Calverton, MD 20705 USA). The data from the 2011 Bangladesh Demographic and Health Survey (BDHS), conducted under the authority of the National Institute of Population Research and Training (NIPORT) of the Ministry of Health and Family Welfare of Bangladesh will be used for this study. Mitra and Associates, a Bangladeshi research firm located in Dhaka implemented the survey and ICF International of Calverton, Maryland, USA, arranged the technical support to the mission as the part of its international Demographic and Health Surveys database (MEASURE DHS). Procedures and questionnaires for standard DHS surveys have been reviewed and approved by the ICF International Institutional Review Board (IRB). (See more at: http://www.dhsprogram.com/What-We-Do/Protecting-the-Privacy-of-DHS-Survey-Respondents.cfm#sthash.qc30dbXO.dpuf) The data collection processes for the BDHS was executed as per the approval of the ORC Macro-institutional review board. The survey protocol was reviewed and approved by the National Ethics Review Committee of the Bangladesh Ministry of Health and Family Welfare. As per BDHS guidelines, informed consent was obtained from all respondents before starting the interview along with an oral clarification offered by the interviewers themselves. Respondents were well informed with regards to the intended use of the gathered data (assessment of health needs and planning health services), the voluntary nature of the study, potential risks of participation in the study, the confidentiality of answers/results of the individual interview and biomarker assay, and that the examination was free of cost. Prior to the blood collection and examination, participants were also well informed about the purpose of the study.
A stratified, multistage cluster sampling strategy was followed in order to construct a national representative household-based sample. To generate this, 600 primary sampling units (207 from urban areas and 393 from rural areas) were raised from the sampling frame created for the 2011 Bangladeshi census. From each primary sampling unit, households were nominated randomly and 17,964 households were selected for interview. Face-to-face interviews were effectively completed among 17,141 selected households. Finally, in these households a total of 18,222 ever married women age 12-49 were identified and 17,842 were interviewed successfully. A total of 5920 ever-married women aged between 15-49 years who resided in one-third of the randomly selected households were selected as subjects for the biomarker assay for anemia study.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Ever married Women in Bangladesh
Key inclusion criteria (1 listed)
- Ever-married women: Those who get married, divorced and the widow is also included.
Key exclusion criteria (1 listed)
- Not married women: Those who never married.
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
Anemia
Time frame: Baseline
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.
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 19 Apr 2017.
- Individual participant dataSharing planned: No
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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.
GM R. Islam, PhD principal investigator
Shahjalal University of Science and Technology
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 Anemia, run by Shahjalal University of Science and Technology 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 1 inclusion and 1 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 19 Apr 2017. 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?
Anemia (time frame: Baseline). 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 19 Apr 2017.