Clinical trial NCT04002466: Anemia Etiology Evaluation in Ethiopia
Official title: Evaluation of Dietary Iron Intake, Anemia, and Iron Status Among Men, Women, and Children in Ethiopia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anemia
Lead sponsor: Harvard School of Public Health (HSPH)
Sponsor class: OTHER
Collaborators: name: Addis Continental Institute of Public Health
First posted: 2019-06-28
Enrollment: 5114
Sex: ALL
Minimum age (years): 6
Maximum age (years): 48
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Children (6-59 months); Women of reproductive age (15-49 years); Adult men (15-49 years)

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.

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.

Eligibility 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

Primary outcomes:
measure: Anemia
timeFrame: One day
Secondary outcomes:
Other outcomes:
Locations:
city: Addis Ababa
country: Ethiopia
facility: Addis Continental Institute of Public Health
Study officials:
affiliation: Harvard School of Public Health (HSPH)
name: Wafaie W Fawzi, MBBS, DrPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tadesse AW, Hemler EC, Andersen C, Passarelli S, Worku A, Sudfeld CR, Berhane Y, Fawzi WW. Anemia prevalence and etiology among women, men, and children in Ethiopia: a study protocol for a national population-based survey. BMC Public Health. 2019 Oct 24;19(1):1369. doi: 10.1186/s12889-019-7647-7.