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Trial record 1 of 1 for:    NCT04002466
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Anemia Etiology Evaluation in Ethiopia (AnemEE)

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ClinicalTrials.gov Identifier: NCT04002466
Recruitment Status : Completed
First Posted : June 28, 2019
Last Update Posted : July 28, 2020
Sponsor:
Collaborator:
Addis Continental Institute of Public Health
Information provided by (Responsible Party):
Wafaie Fawzi, Harvard School of Public Health

Brief Summary:
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.

Condition or disease Intervention/treatment
Anemia Other: Risk factors for anemia

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.

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Study Type : Observational
Actual Enrollment : 5114 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Evaluation of Dietary Iron Intake, Anemia, and Iron Status Among Men, Women, and Children in Ethiopia
Actual Study Start Date : January 27, 2019
Actual Primary Completion Date : August 15, 2019
Actual Study Completion Date : August 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia

Group/Cohort Intervention/treatment
Children (6-59 months) Other: Risk factors for anemia
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) Other: Risk factors for anemia
Diet, iron, vitamin B12, folate, inflammation, soil transmitted helminth infection, malaria, other morbidities and other health/nutrition/sociodemographic factors

Adult Men (15-49 years) Other: Risk factors for anemia
Diet, iron, vitamin B12, folate, inflammation, soil transmitted helminth infection, malaria, other morbidities and other health/nutrition/sociodemographic factors




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   6 Months to 48 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Children (6-59 months); Women of reproductive age (15-49 years); Adult men (15-49 years)
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04002466


Locations
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Ethiopia
Addis Continental Institute of Public Health
Addis Ababa, Ethiopia
Sponsors and Collaborators
Harvard School of Public Health
Addis Continental Institute of Public Health
Investigators
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Principal Investigator: Wafaie W Fawzi, MBBS, DrPH Harvard School of Public Health
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Wafaie Fawzi, Professor of Nutrition, Epidemiology, and Global Health, Harvard School of Public Health
ClinicalTrials.gov Identifier: NCT04002466    
Other Study ID Numbers: OPP1179606
First Posted: June 28, 2019    Key Record Dates
Last Update Posted: July 28, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anemia
Hematologic Diseases