Anemia Etiology Evaluation in Ethiopia (AnemEE)

July 27, 2020 updated by: Wafaie Fawzi, Harvard School of Public Health (HSPH)

Evaluation of Dietary Iron Intake, Anemia, and Iron Status Among Men, Women, and Children in Ethiopia

The AnemEE study is a population-based anemia etiology survey in six regions of Ethiopia. The primary aim of the study is to evaluate the relative contribution of risk factors for anemia among children, women of reproductive age, and adult men. The study data are intended to inform evidence-based decision-making on anemia control interventions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The AnemEE study is a population-based cross-sectional survey of children (6-59 months), adult women of reproductive age (15-49 years) and adult males (15-49 years) in six regions of Ethiopia (Afar, Amhara, Tigray, Oromia, Southern Nations, Nationalities and Peoples' Region and Addis Ababa). The study will enroll approximately 5,100 participants and will be conducted in two survey rounds; one survey round in the Belg season and one survey round in the Meher season. All participants will have hemoglobin assessed and will have standardized questionnaires administered to assess sociodemographic, diet, morbidity, and other health/nutrition factors. All participants will also have assessments of anthropometric measures, malaria, and soil transmitted helminth infection. A subset of participants will also have serum ferritin, CRP, AGP, vitamin B12, and folate concentrations assessed. The study data will be used to determine the relative contributions of risk factors for anemia.

Study Type

Observational

Enrollment (Actual)

5114

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Addis Ababa, Ethiopia
        • Addis Continental Institute of Public Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 48 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Children (6-59 months); Women of reproductive age (15-49 years); Adult men (15-49 years)

Description

Inclusion Criteria:

  1. Women of reproductive age

    • Female living in a selected household that has a woman 15-49 years of age
    • Aged 15-49 years
  2. Adult Men

    • Male living in a selected household that has a woman 15-49 years of age
    • Aged 15-49 years
  3. Children

    • Male or female child living in a selected household that has a woman 15-49 years of age
    • Aged 6-59 months

Exclusion Criteria:

  • Does not provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Children (6-59 months)
Diet, iron, vitamin B12, folate, inflammation, soil transmitted helminth infection, malaria, other morbidities and other health/nutrition/sociodemographic factors
Women of Reproductive Age (15-49 years)
Diet, iron, vitamin B12, folate, inflammation, soil transmitted helminth infection, malaria, other morbidities and other health/nutrition/sociodemographic factors
Adult Men (15-49 years)
Diet, iron, vitamin B12, folate, inflammation, soil transmitted helminth infection, malaria, other morbidities and other health/nutrition/sociodemographic factors

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anemia
Time Frame: One day
Hemoglobin concentration by sex and age (<11 g/dL for children; Hb <12 g/dL for non-pregnant adult women, <13 g/dL for adult men). Hemoglobin concentrations will be adjusted for altitude and smoking status.
One day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Wafaie W Fawzi, MBBS, DrPH, Harvard School of Public Health (HSPH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 27, 2019

Primary Completion (Actual)

August 15, 2019

Study Completion (Actual)

August 15, 2019

Study Registration Dates

First Submitted

June 21, 2019

First Submitted That Met QC Criteria

June 27, 2019

First Posted (Actual)

June 28, 2019

Study Record Updates

Last Update Posted (Actual)

July 28, 2020

Last Update Submitted That Met QC Criteria

July 27, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPP1179606

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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