Anemia Etiology Evaluation in Ethiopia

Anemia Clinical Trial

— AnemEE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04002466
• Other study ID #: OPP1179606
• Status: Completed
• Start date: January 27, 2019
• Est. completion date: August 15, 2019

Study information

• Verified date: July 2020
• Source: Harvard School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5114
• Est. completion date: August 15, 2019
• Est. primary completion date: August 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 48 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia

Intervention

Other:
• Risk factors for anemia
Diet, iron, vitamin B12, folate, inflammation, soil transmitted helminth infection, malaria, other morbidities and other health/nutrition/sociodemographic factors

Locations

Country	Name	City	State
Ethiopia	Addis Continental Institute of Public Health	Addis Ababa

Sponsors (2)

Lead Sponsor	Collaborator
Harvard School of Public Health	Addis Continental Institute of Public Health

Country where clinical trial is conducted

Ethiopia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anemia	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