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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05626647
Other study ID # IRB-21-505
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 1, 2021
Est. completion date September 4, 2022

Study information

Verified date November 2022
Source Oklahoma State University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study aims to determine the etiology of anemia among preschool children in selected regions of Ethiopia. The study is a longitudinal observational study to assess the determinant factors of anemia in two different seasons. The main questions it aims to answer are: 1. What is the prevalence and etiology of anemia in the two different (Post and Pre-harvest) seasons? 2. What is the strength of the interaction between anemia and each of the determinant factors being considered? The participant's dietary intake and anthropometric measurement have been assessed, and biological samples (Blood and Stool) were collected to determine the prevalence of anemia and the factors contributing to it.


Description:

Background: Although the country made a significant change in the burden of malnutrition in all its forms in the past two decades, the issue remains unacceptably high across all regions of Ethiopia. The national prevalence of anemia among children 6-59 months was very high 57% and one of the public health concerns in 2016. Although the country is known as a data-rich country, in some specific indicators, there is a lack of data and evidence to alleviate the nutritional gaps through an informed decision-making process. In this particular case, there is a lack of evidence relating to child anemia in Ethiopia, especially since there is no comprehensive information about the determinant factors of anemia. Objective: The objective of the current survey is to determine the etiology of anemia and its public health implications among under-five children in selected ecological zones of Ethiopia at different seasons. Method: This survey will be a community-based, longitudinal panel study and will be conducted in two different (post-harvest and pre-harvest) seasons in the 2014 Ethiopian calendar year. A nationally representative sample was calculated and allocated to three purposely selected regions (Amhara, Southern Nation, Nationalities, and Peoples' Region (SNNPR), and Somali) in consideration of three different ecological zones (lowlands, midlands, and highlands). The study population will be children aged 6 - 59 months with caregivers/mothers with a sample size of 1212 under-five children from 1212 households. The indicators collected for the survey are dietary intake, anthropometric measurement, and biological samples (Blood and Stool). Expected benefit: The findings of this survey will provide information on the etiology of anemia that will inform short-term policy decisions, especially for case-specific nutrition-sensitive interventions, and that will contribute to long-term policy decisions for comprehensive nutrition intervention programs.


Recruitment information / eligibility

Status Completed
Enrollment 590
Est. completion date September 4, 2022
Est. primary completion date March 4, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Months to 59 Months
Eligibility Inclusion Criteria: - Children 6-53 months during the baseline survey and who have stayed more than 6 months in the selected household of the Amhara or SNNPR or Somali regions of Ethiopia and have no plan to move from the study area during the study period Exclusion Criteria: - Children older than the youngest child between 6-53 months of age (If more than one eligible child is in the Household) during the baseline survey. - Children with severe illness - Guests - If participants lose their willingness to participate in this study

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Ethiopia Ethiopian Public Health Institute Addis Ababa

Sponsors (3)

Lead Sponsor Collaborator
Oklahoma State University Addis Ababa University, Ethiopian Public Health Institute

Country where clinical trial is conducted

Ethiopia, 

References & Publications (1)

Anemia prevalence among preschool children in 2016 is 57%. EDHS, "Ethiopian Demography and Health Survey 2016, Central Statistical Agency (CSA).," Addis Ababa, Ethiopia, 2016.

Outcome

Type Measure Description Time frame Safety issue
Primary Prevalence of anemia among preschool children in selected regions of Ethiopia in the two different (Post and Pre harvest) seasons? Blood hemoglobin level below 11mg/dL From November 2021 to September 2022
Secondary Factors contributing to anemia anemia among preschool children in selected regions of Ethiopia in the two different (Post and Pre harvest) seasons? Micronutrient deficiency, presence of infectious disease, and genetic problems contributing to low hemoglobin concentration. From November 2021 to September 2022
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