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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

Tracking Information
First Submitted Date June 21, 2019
First Posted Date June 28, 2019
Last Update Posted Date July 28, 2020
Actual Study Start Date January 27, 2019
Actual Primary Completion Date August 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 27, 2019)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Anemia Etiology Evaluation in Ethiopia
Official Title Evaluation of Dietary Iron Intake, Anemia, and Iron Status Among Men, Women, and Children in Ethiopia
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.
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Children (6-59 months); Women of reproductive age (15-49 years); Adult men (15-49 years)
Condition 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
Study Groups/Cohorts
  • Children (6-59 months)
    Intervention: Other: Risk factors for anemia
  • Women of Reproductive Age (15-49 years)
    Intervention: Other: Risk factors for anemia
  • Adult Men (15-49 years)
    Intervention: Other: Risk factors for anemia
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 27, 2020)
5114
Original Estimated Enrollment
 (submitted: June 27, 2019)
5100
Actual Study Completion Date August 15, 2019
Actual Primary Completion Date August 15, 2019   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 6 Months to 48 Years   (Child, Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Ethiopia
Removed Location Countries  
 
Administrative Information
NCT Number NCT04002466
Other Study ID Numbers OPP1179606
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Wafaie Fawzi, Harvard School of Public Health
Study Sponsor Harvard School of Public Health
Collaborators Addis Continental Institute of Public Health
Investigators
Principal Investigator: Wafaie W Fawzi, MBBS, DrPH Harvard School of Public Health
PRS Account Harvard School of Public Health
Verification Date July 2020