AnemiaAnemEENCT04002466
Anemia Etiology Evaluation in Ethiopia
An observational study of Anemia, run by Harvard School of Public Health (HSPH) at 1 site in Ethiopia.
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. Read more about this study
- Who is it for?
- Ages 6 months to 48 yearsHealthy volunteers can take part
- Conditions the study is for
- Anemia
- What is being tested?
- Risk factors for anemia
- How many people
- 5,114 participants
- Where
- 1 siteEthiopia
- Study dates
- 27 Jan 2019to 15 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 48 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Children (6-59 months); Women of reproductive age (15-49 years); Adult men (15-49 years)
Who may be able to join
- 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
Show all 9Show fewer
- Children
- Male or female child living in a selected household that has a woman 15-49 years of age
- Aged 6-59 months
Who cannot join
- Does not provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Anemia
- Being tested
- Risk factors for anemia
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk factors for anemiaOther
Diet, iron, vitamin B12, folate, inflammation, soil transmitted helminth infection, malaria, other morbidities and other health/nutrition/sociodemographic factors
| Study group | Role | What they receive |
|---|---|---|
| Children (6-59 months) | Not described Receives: Other: Risk factors for anemia | |
| Women of Reproductive Age (15-49 years) | Not described Receives: Other: Risk factors for anemia | |
| Adult Men (15-49 years) | Not described Receives: Other: Risk factors for anemia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2019
- Study start27 Jan 2019
- Primary completion15 Aug 2019
- Study completion15 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 5,114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Collaborators
- Addis Continental Institute of Public Health
- Responsible party
- Principal investigator, Wafaie Fawzi, Harvard School of Public Health (HSPH)
- Investigators
- Wafaie W Fawzi, MBBS, DrPH, Principal investigator, Harvard School of Public Health (HSPH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04002466
- Sponsor's protocol ID
- OPP1179606
- Acronym
- AnemEE
- Status last verified
- Jul 2020
- First submitted
- 21 Jun 2019
- Last updated
- 28 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 31651278
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Dietary Iron Intake, Anemia, and Iron Status Among Men, Women, and Children in Ethiopia
- ClinicalTrials.gov ID
- NCT04002466
- Acronym / sponsor ID
- AnemEE / OPP1179606
- Conditions
- Anemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,114 participants (actual)
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Collaborators
- Addis Continental Institute of Public Health
- Study start
- 27 Jan 2019 (actual)
- Primary completion
- 15 Aug 2019 (actual)
- Study completion
- 15 Aug 2019 (actual)
- First posted
- 28 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Children (6-59 months) | – | Other: Risk factors for anemia |
| Women of Reproductive Age (15-49 years) | – | Other: Risk factors for anemia |
| Adult Men (15-49 years) | – | Other: Risk factors for anemia |
Who may qualify
- Ages
- 6 months to 48 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Children (6-59 months); Women of reproductive age (15-49 years); Adult men (15-49 years)
Key inclusion criteria (9 listed)
- Women of reproductive age
- Adult Men
- Children
Key exclusion criteria (1 listed)
- Does not provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Risk factors for anemiaDiet, iron, vitamin B12, folate, inflammation, soil transmitted helminth infection, malaria, other morbidities and other health/nutrition/sociodemographic factors | Other | Adult Men (15-49 years), Children (6-59 months), Women of Reproductive Age (15-49 years) |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2020.
- Derived from this study: PubMed 31651278Tadesse 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wafaie W Fawzi, MBBS, DrPH principal investigator
Harvard School of Public Health (HSPH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anemia, run by Harvard School of Public Health (HSPH) at 1 site in Ethiopia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anemia (time frame: One day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04002466, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2020.