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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03126253
Other study ID # FET-CA
Secondary ID
Status Completed
Phase N/A
First received April 19, 2017
Last updated April 21, 2017
Start date May 11, 2011
Est. completion date January 18, 2012

Study information

Verified date April 2017
Source Shahjalal University of Science and Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 2320
Est. completion date January 18, 2012
Est. primary completion date July 8, 2011
Accepts healthy volunteers
Gender All
Age group 6 Months to 59 Months
Eligibility Inclusion Criteria:

- Infant: Less than or equal to 12 months old

- Toddler: between 13-36 months

- Preschool children: between 37-59 month

Exclusion Criteria:

- Child 0-5 months

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Anemia
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.

Locations

Country Name City State
Bangladesh Data analysis Sylhet

Sponsors (1)

Lead Sponsor Collaborator
Shahjalal University of Science and Technology

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type Measure Description Time frame Safety issue
Primary Anemia Blood hemoglobin level will be used as the parameter for diagnosing anemia. Baseline
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