Causes of Anemia Among Women of Reproductive Age

Sponsor
Ethiopian Public Health Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT05669209
Collaborator
Oklahoma State University (Other), Addis Ababa University (Other)
881
1
1.5
570.5

Study Details

Study Description

Brief Summary

The goal of this observational study is to assess the causes of anemia in women of reproductive age. The main questions it aims to answer are:

  • What are the causes of anemia among women of reproductive age?

  • What is the contribution of iron deficiency to overall anemia?

  • What is the prevalence of hemoglobinopathies among women of reproductive age with anemia?

Participants will be asked to respond to the interview questions, and provide blood, urine, and stool samples.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    One-third of the global population is affected by anemia making it one of the major public health problems at the global level. Women of reproductive age are at risk for anemia. The prevalence of anemia reported in 2016 Ethiopian Demographic and Health Survey (EDHS) is a moderate public health problem at the national level, but it is a severe public health problem in the Somali regional state among women of reproductive age (WRA). The purpose of this study is to assess the etiology and determinant factors of anemia among women of reproductive age. A cross-sectional design will be employed for the current study. In the current study, the investigators will assess the causes and contributing factors for anemia and their relationship with anemia. Women of reproductive age 18-49 years old residing in the Kebribeyah district are the target population for this study. The sample size determined for the current study is 881. The Somali region was selected for the current study due to its highest prevalence of anemia (60.6%%) among women of reproductive age according to the EDHS 2016. Kerbribeyah district was selected from the Somali regional state. Simple random sampling was employed to select three kebeles (villages) from the available kebeles with no other nutrition interventions in the Kebribeyah district. Two enumerations areas (EAs) from each of the three kebeles will be selected by simple random sampling. The sample size determined will be allocated to three kebeles and two EAs within the Kebeles on probability proportional to size (PPS). The study participants will be selected by systematic random sampling from a list of participants in a sampling frame obtained by house-to-house listing. After obtaining written informed consent, the data will be collected from the selected participant in their homes. All study participants who take part in the current study will be interviewed. They will also provide blood, urine, and stool samples. The prevalence of anemia and iron status biomarkers are the primary outcomes for the current study. The participants will be tested for anemia by measuring hemoglobin concentration. In addition, a complete blood count (CBC) test will be done for all study participants. The current study will fill the evidence gap by identifying major causes and contributors to overall anemia among women of reproductive age in the Kebribeyah district. The researchers anticipate that determining the causes of anemia will be a crucial first step in tackling the high prevalence of anemia among women of reproductive age in the Somali regional state and beyond.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    881 participants
    Observational Model:
    Ecologic or Community
    Time Perspective:
    Cross-Sectional
    Official Title:
    Etiology and Contributing Factors of Anemia Among Women of Reproductive Age at Kebribeyah District in the Somali Regional State, Ethiopia
    Actual Study Start Date :
    Dec 16, 2022
    Anticipated Primary Completion Date :
    Feb 1, 2023
    Anticipated Study Completion Date :
    Feb 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Anemia prevalence [Single blood sample collected for the cross-sectional baseline study throughout a month on average.]

      Anemia is diagnosed when the hemoglobin concentration test result is less than 12g/dl.

    2. Iron deficiency anemia [Single blood sample collected for the cross-sectional baseline study throughout a month on average]

      Iron deficiency anemia is diagnosed when serum ferritin concentration is less than 15μg/L and hemoglobin concentration is less than 12g/dl.

    Secondary Outcome Measures

    1. Socioeconomic Status (SES) [From the cross-sectional baseline study conducted throughout a month on average]

      Socioeconomic status will be assessed by using principal component analysis (PCA) from socio-demographic information collected.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 49 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • age range 18-49 years

    • Permanent resident in the selected kebele (have lived for at least six months) in the kebele (village).

    Exclusion Criteria:
    • Women below or above the age range 18-49 years

    • All pregnant women

    • Women who are severely ill and incapacitated.

    • Non-permanent resident women in the kebele (village)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ethiopian Public Health Institute Addis Ababa Ethiopia 1242

    Sponsors and Collaborators

    • Ethiopian Public Health Institute
    • Oklahoma State University
    • Addis Ababa University

    Investigators

    • Study Director: Masresha Tessema, PhD, Ethiopian Public Health Institute (EPHI)

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Desalegn Kuche, Researcher for nutrition, Ethiopian Public Health Institute
    ClinicalTrials.gov Identifier:
    NCT05669209
    Other Study ID Numbers:
    • EPHI_IRB_410_2021_1
    First Posted:
    Dec 30, 2022
    Last Update Posted:
    Dec 30, 2022
    Last Verified:
    Dec 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Desalegn Kuche, Researcher for nutrition, Ethiopian Public Health Institute
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 30, 2022