AnemiaNCT03126253
The Burden of Childhood Anemia in Bangladesh: Does Socioeconomic Status Matter?
An observational study of Anemia, run by Shahjalal University of Science and Technology at 1 site in Bangladesh.
Trial summary
Childhood anemia is a global public health problem that is associated with life-threatening consequences such as growth retardation, impaired motor and cognitive development, and increased morbidity and mortality. Read more about this study
- Who is it for?
- Ages 6 to 59 months
- Conditions the study is for
- Anemia
- What is being tested?
- Anemia
- How many people
- 2,320 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 6 to 59 months
- All sexes
- Child
Study population: children 6-59 month of age in Bangladesh
Who may be able to join
- Infant: Less than or equal to 12 months old
- Toddler: between 13-36 months
- Preschool children: between 37-59 month
Who cannot join
- Child 0-5 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Burden of Childhood Anemia in Bangladesh:
Childhood anemia is a global public health problem that is associated with life-threatening consequences such as growth retardation, impaired motor and cognitive development, and increased morbidity and mortality. Anemia can be caused by a variety of factors such as nutritional deficiencies (i.e., iron, folic acid, vitamin B12, and vitamin A), infections (i.e., helminth), and blood disorders (i.e., hemoglobinopathies). The World Health Organization (WHO) estimates that approximately 50% of anemia cases can be attributed to iron deficiency. This is an estimated global average that varies widely depending upon the location in question. The World Bank estimates for 2011 claim that approximately 55.60% of all Bangladeshi children under five years of age are suffering from anemia. The relationship between socioeconomic status (SES) inequality and anemia among the children has never been conclusively and it is unclear if the children of the age group of 6-59 months have uniformly high levels of anemia during all the stages of development, e.g., during the infant, toddler, and preschool stages. In addition, there is a dearth of evidence from Bangladesh, where the meaning of sociodemographic characteristics may be different from that in other countries. Therefore, this study attempts to fill the above-mentioned lacuna by investigating and evaluating the association of SES inequality, among other explanatory variables, on the development of childhood anemia during different stages of child development and to answer the questions: (a) Is SES a factor impeding childhood anemia along with other explanatory variables? (b) In which stage of child development, the chance of disparaging with childhood anemia is highest? (c) Is there evidence of between child development stages differences in the strength and form of association disparities between having childhood anemia and SES? (c) What are the predictive margins for SES-associated anemia in the case of infants, toddlers, and preschool children? The results of this analysis will be reported for elucidating the potential effects of SES and the stages of child development that are usually neglected in the conventional scientific literature. Moreover, as anemia is one of the current key health issues in Bangladesh, it is also expected that the findings of this study would contribute significantly toward shaping the health policy strategy of the country.
Read the detailed description
The data collected by the 2011 Bangladesh Demographic Health Survey (BDHS), conducted by the National Institute for Population Research and Training (Ministry of Health and Family Welfare, Bangladesh), will be used for the purpose of this study. in the BDHS 2011, A nationally representative household-based sample was created through a stratified, multistage cluster sampling strategy in which 600 primary sampling units were constructed (207 in urban areas and 393 in rural areas). The primary sampling units were derived from a sampling frame created for the 2001 Bangladeshi census from seven divisions of Bangladesh. Households were selected randomly from each primary sampling unit. The data pertaining to the socioeconomic and sociodemographic factors were collected using a structured open-ended interview. The questionnaire used for this purpose was modeled on the MEASURE DHS questionnaires. Prior to the use, these questionnaires were adapted for the use in Bangladesh through a series of meetings with a Technical Working Group (TWG) that comprised of representatives from the National Institute of Population Research and Training (NIPORT,) Mitra and Associates, the International Centre for Diarrheal Diseases and Control in Bangladesh (ICDDR, B), USAID/Bangladesh, and MEASURE DH. The questionnaires were drafted in English and then translated into Bangla which is the national language of Bangladesh. The translations were reviewed by the experts as well as by the volunteers and a pilot study was conducted to validate the same. Of the total of 17,964 selected households, face-to-face interviews were successfully completed for 17,141 corresponding to a household response rate of 98%. The subjects for the examination of anemia were 2320 children aged 6-59 months, were raised from every third household of the BDHS sample. After excluding subjects with missing data, a total of 2068 individuals were selected for this analysis.
- Conditions
- Anemia
- Being tested
- Anemia
- Keywords
- childhood anemia, socioeconomic status
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnemiaDiagnostic test
Hemoglobin level will be used as the parameter for diagnosing anemia. The HemoCue system was used to estimate the concentration of hemoglobin in capillary blood. WHO guidelines for the diagnosis of anemia that were adopted by the Demographic Health Surveys will be used in this study. Briefly, a hemoglobin concentration of less than 70 g/L will be consider to define severe anemia, 70-99 g/L for moderate anemia, and 100-109 g/L will be presumed to correspond to mild anemia. The above-mentioned classification of anemia as "severe" "moderate" and "mild" categories is based on blood hemoglobin cutoffs (will be adjusted for altitude and smoking) recommended by the Center for Disease Prevention of United States; this classification has also been adopted by the World Health Organization.
What is being measured
The primary outcome is the main question the study is designed to answer.
Anemia
Blood hemoglobin level will be used as the parameter for diagnosing 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 posted24 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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 2,320 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 MI Islam, PhD, Principal investigator, Shahjalal University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03126253
- Sponsor's protocol ID
- FET-CA
- Status last verified
- Apr 2017
- First submitted
- 19 Apr 2017
- Last updated
- 24 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Islam GMR. Association of Socioeconomic Status With Childhood Anemia Among Infant, Toddler, and Preschool Children in Bangladesh. Value Health Reg Issues. 2020 May;21:141-148. doi: 10.1016/j.vhri.2019.09.008. Epub 2019 Dec 5.
PubMed 31812112
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Burden of Childhood Anemia in Bangladesh:
- ClinicalTrials.gov ID
- NCT03126253
- Acronym / sponsor ID
- FET-CA
- Conditions
- Anemia
- Keywords
- childhood anemia, socioeconomic status
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,320 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
- 24 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.
Childhood anemia is a global public health problem that is associated with life-threatening consequences such as growth retardation, impaired motor and cognitive development, and increased morbidity and mortality. Anemia can be caused by a variety of factors such as nutritional deficiencies (i.e., iron, folic acid, vitamin B12, and vitamin A), infections (i.e., helminth), and blood disorders (i.e., hemoglobinopathies). The World Health Organization (WHO) estimates that approximately 50% of anemia cases can be attributed to iron deficiency. This is an estimated global average that varies widely depending upon the location in question. The World Bank estimates for 2011 claim that approximately 55.60% of all Bangladeshi children under five years of age are suffering from anemia. The relationship between socioeconomic status (SES) inequality and anemia among the children has never been conclusively and it is unclear if the children of the age group of 6-59 months have uniformly high levels of anemia during all the stages of development, e.g., during the infant, toddler, and preschool stages. In addition, there is a dearth of evidence from Bangladesh, where the meaning of sociodemographic characteristics may be different from that in other countries. Therefore, this study attempts to fill the above-mentioned lacuna by investigating and evaluating the association of SES inequality, among other explanatory variables, on the development of childhood anemia during different stages of child development and to answer the questions: (a) Is SES a factor impeding childhood anemia along with other explanatory variables? (b) In which stage of child development, the chance of disparaging with childhood anemia is highest? (c) Is there evidence of between child development stages differences in the strength and form of association disparities between having childhood anemia and SES? (c) What are the predictive margins for SES-associated anemia in the case of infants, toddlers, and preschool children? The results of this analysis will be reported for elucidating the potential effects of SES and the stages of child development that are usually neglected in the conventional scientific literature. Moreover, as anemia is one of the current key health issues in Bangladesh, it is also expected that the findings of this study would contribute significantly toward shaping the health policy strategy of the country.
Detailed description
The data collected by the 2011 Bangladesh Demographic Health Survey (BDHS), conducted by the National Institute for Population Research and Training (Ministry of Health and Family Welfare, Bangladesh), will be used for the purpose of this study. in the BDHS 2011, A nationally representative household-based sample was created through a stratified, multistage cluster sampling strategy in which 600 primary sampling units were constructed (207 in urban areas and 393 in rural areas). The primary sampling units were derived from a sampling frame created for the 2001 Bangladeshi census from seven divisions of Bangladesh. Households were selected randomly from each primary sampling unit. The data pertaining to the socioeconomic and sociodemographic factors were collected using a structured open-ended interview. The questionnaire used for this purpose was modeled on the MEASURE DHS questionnaires. Prior to the use, these questionnaires were adapted for the use in Bangladesh through a series of meetings with a Technical Working Group (TWG) that comprised of representatives from the National Institute of Population Research and Training (NIPORT,) Mitra and Associates, the International Centre for Diarrheal Diseases and Control in Bangladesh (ICDDR, B), USAID/Bangladesh, and MEASURE DH. The questionnaires were drafted in English and then translated into Bangla which is the national language of Bangladesh. The translations were reviewed by the experts as well as by the volunteers and a pilot study was conducted to validate the same. Of the total of 17,964 selected households, face-to-face interviews were successfully completed for 17,141 corresponding to a household response rate of 98%. The subjects for the examination of anemia were 2320 children aged 6-59 months, were raised from every third household of the BDHS sample. After excluding subjects with missing data, a total of 2068 individuals were selected for this analysis.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Age groups
- Child
- Study population
- children 6-59 month of age in Bangladesh
Key inclusion criteria (3 listed)
- Infant: Less than or equal to 12 months old
- Toddler: between 13-36 months
- Preschool children: between 37-59 month
Key exclusion criteria (1 listed)
- Child 0-5 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AnemiaHemoglobin level will be used as the parameter for diagnosing anemia. The HemoCue system was used to estimate the concentration of hemoglobin in capillary blood. WHO guidelines for the diagnosis of anemia that were adopted by the Demographic Health Surveys will be used in this study. Briefly, a hemoglobin concentration of less than 70 g/L will be consider to define severe anemia, 70-99 g/L for moderate anemia, and 100-109 g/L will be presumed to correspond to mild anemia. The above-mentioned classification of anemia as "severe" "moderate" and "mild" categories is based on blood hemoglobin cutoffs (will be adjusted for altitude and smoking) recommended by the Center for Disease Prevention of United States; this classification has also been adopted by the World Health Organization. | Diagnostic test | – |
Primary outcome
Anemia
Time frame: Baseline
Blood hemoglobin level will be used as the parameter for diagnosing 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 24 Apr 2017.
- Derived from this study: PubMed 31812112Islam GMR. Association of Socioeconomic Status With Childhood Anemia Among Infant, Toddler, and Preschool Children in Bangladesh. Value Health Reg Issues. 2020 May;21:141-148. doi: 10.1016/j.vhri.2019.09.008. Epub 2019 Dec 5.
- Report of the surveyLink provided by the sponsor.
- 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 MI 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 3 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 24 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?
On the ClinicalTrials.gov record for NCT03126253, which also lists 1 linked publication.
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 24 Apr 2017.