- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04002466
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
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
-
-
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Addis Ababa, Ethiopia
- Addis Continental Institute of Public Health
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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:
Women of reproductive age
- Female living in a selected household that has a woman 15-49 years of age
- Aged 15-49 years
Adult Men
- Male living in a selected household that has a woman 15-49 years of age
- Aged 15-49 years
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)
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Diet, iron, vitamin B12, folate, inflammation, soil transmitted helminth infection, malaria, other morbidities and other health/nutrition/sociodemographic factors
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Women of Reproductive Age (15-49 years)
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Diet, iron, vitamin B12, folate, inflammation, soil transmitted helminth infection, malaria, other morbidities and other health/nutrition/sociodemographic factors
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Adult Men (15-49 years)
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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
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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.
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One day
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
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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