AnemiaNCT05626647
Etiology of Anemia Among Preschool Children in Ethiopia
An observational study of Anemia, run by Oklahoma State University at 1 site in Ethiopia.
Trial summary
This study aims to determine the etiology of anemia among preschool children in selected regions of Ethiopia. The study is a longitudinal observational study to assess the determinant factors of anemia in two different seasons. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 6 to 59 monthsHealthy volunteers can take part
- Conditions the study is for
- Anemia
- How many people
- 590 participants
- Where
- 1 siteEthiopia
- Study dates
- 1 Nov 2021to 4 Sep 2022
- 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 to 59 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children at the age of 6 to 59 months in each randomly selected eligible household of the Amhara or SNNPR or Somali regions of Ethiopia were the study population for this study but, during the baseline survey, we found children 6 to 53 months to retain the same child at the endline survey below five years old.
Who may be able to join
- Children 6-53 months during the baseline survey and who have stayed more than 6 months in the selected household of the Amhara or SNNPR or Somali regions of Ethiopia and have no plan to move from the study area during the study period
Who cannot join
- Children older than the youngest child between 6-53 months of age (If more than one eligible child is in the Household) during the baseline survey.
- Children with severe illness
- Guests
- If participants lose their willingness to participate in this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Etiology of Anemia Among Preschool Children and Its Public Health Implication in Selected Regions of Ethiopia: A Community-Based Longitudinal Study
This study aims to determine the etiology of anemia among preschool children in selected regions of Ethiopia. The study is a longitudinal observational study to assess the determinant factors of anemia in two different seasons.
The main questions it aims to answer are:
- What is the prevalence and etiology of anemia in the two different (Post and Pre-harvest) seasons?
- What is the strength of the interaction between anemia and each of the determinant factors being considered?
The participant's dietary intake and anthropometric measurement have been assessed, and biological samples (Blood and Stool) were collected to determine the prevalence of anemia and the factors contributing to it.
Read the detailed description
Background: Although the country made a significant change in the burden of malnutrition in all its forms in the past two decades, the issue remains unacceptably high across all regions of Ethiopia. The national prevalence of anemia among children 6-59 months was very high 57% and one of the public health concerns in 2016. Although the country is known as a data-rich country, in some specific indicators, there is a lack of data and evidence to alleviate the nutritional gaps through an informed decision-making process. In this particular case, there is a lack of evidence relating to child anemia in Ethiopia, especially since there is no comprehensive information about the determinant factors of anemia.
Objective: The objective of the current survey is to determine the etiology of anemia and its public health implications among under-five children in selected ecological zones of Ethiopia at different seasons.
Method: This survey will be a community-based, longitudinal panel study and will be conducted in two different (post-harvest and pre-harvest) seasons in the 2014 Ethiopian calendar year. A nationally representative sample was calculated and allocated to three purposely selected regions (Amhara, Southern Nation, Nationalities, and Peoples' Region (SNNPR), and Somali) in consideration of three different ecological zones (lowlands, midlands, and highlands). The study population will be children aged 6 - 59 months with caregivers/mothers with a sample size of 1212 under-five children from 1212 households. The indicators collected for the survey are dietary intake, anthropometric measurement, and biological samples (Blood and Stool).
Expected benefit: The findings of this survey will provide information on the etiology of anemia that will inform short-term policy decisions, especially for case-specific nutrition-sensitive interventions, and that will contribute to long-term policy decisions for comprehensive nutrition intervention programs.
- Conditions
- Anemia
- Keywords
- Etiology, Anemia, Preschool
- Medical subject headings
- Anemia
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of anemia among preschool children in selected regions of Ethiopia in the two different (Post and Pre harvest) seasons?
Blood hemoglobin level below 11mg/dL
Measured: From November 2021 to September 2022
Secondary outcomes (1)
Factors contributing to anemia anemia among preschool children in selected regions of Ethiopia in the two different (Post and Pre harvest) seasons?
Micronutrient deficiency, presence of infectious disease, and genetic problems contributing to low hemoglobin concentration.
Measured: From November 2021 to September 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2022
- Study start1 Nov 2021
- Primary completion4 Mar 2022
- Study completion4 Sep 2022
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
- Ecologic or community
- Time perspective
- Other
- Enrolment
- 590 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oklahoma State University
- Sponsor type
- University, hospital or other
- Collaborators
- Ethiopian Public Health Institute, Addis Ababa University
- Responsible party
- Principal investigator, Solomon Hailu, Oklahoma State University
- Investigators
- Barbara J Stocker, Prof, Study chair, Oklahoma State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05626647
- Sponsor's protocol ID
- IRB-21-505
- Status last verified
- Nov 2022
- First submitted
- 15 Nov 2022
- Last updated
- 29 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual Participant Data (IPD) can be shared upon request and signing of an agreement between the Ethiopian Public Health Institute and the interested party.
Publications
Anemia prevalence among preschool children in 2016 is 57%. EDHS, "Ethiopian Demography and Health Survey 2016, Central Statistical Agency (CSA).," Addis Ababa, Ethiopia, 2016.
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etiology of Anemia Among Preschool Children and Its Public Health Implication in Selected Regions of Ethiopia: A Community-Based Longitudinal Study
- ClinicalTrials.gov ID
- NCT05626647
- Acronym / sponsor ID
- IRB-21-505
- Conditions
- Anemia
- Keywords
- Etiology, Anemia, Preschool
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 590 participants (actual)
- Lead sponsor
- Oklahoma State UniversityUniversity, hospital or other
- Collaborators
- Ethiopian Public Health Institute, Addis Ababa University
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 4 Mar 2022 (actual)
- Study completion
- 4 Sep 2022 (actual)
- First posted
- 25 Nov 2022 (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.
This study aims to determine the etiology of anemia among preschool children in selected regions of Ethiopia. The study is a longitudinal observational study to assess the determinant factors of anemia in two different seasons.
The main questions it aims to answer are:
- What is the prevalence and etiology of anemia in the two different (Post and Pre-harvest) seasons?
- What is the strength of the interaction between anemia and each of the determinant factors being considered?
The participant's dietary intake and anthropometric measurement have been assessed, and biological samples (Blood and Stool) were collected to determine the prevalence of anemia and the factors contributing to it.
Detailed description
Background: Although the country made a significant change in the burden of malnutrition in all its forms in the past two decades, the issue remains unacceptably high across all regions of Ethiopia. The national prevalence of anemia among children 6-59 months was very high 57% and one of the public health concerns in 2016. Although the country is known as a data-rich country, in some specific indicators, there is a lack of data and evidence to alleviate the nutritional gaps through an informed decision-making process. In this particular case, there is a lack of evidence relating to child anemia in Ethiopia, especially since there is no comprehensive information about the determinant factors of anemia.
Objective: The objective of the current survey is to determine the etiology of anemia and its public health implications among under-five children in selected ecological zones of Ethiopia at different seasons.
Method: This survey will be a community-based, longitudinal panel study and will be conducted in two different (post-harvest and pre-harvest) seasons in the 2014 Ethiopian calendar year. A nationally representative sample was calculated and allocated to three purposely selected regions (Amhara, Southern Nation, Nationalities, and Peoples' Region (SNNPR), and Somali) in consideration of three different ecological zones (lowlands, midlands, and highlands). The study population will be children aged 6 - 59 months with caregivers/mothers with a sample size of 1212 under-five children from 1212 households. The indicators collected for the survey are dietary intake, anthropometric measurement, and biological samples (Blood and Stool).
Expected benefit: The findings of this survey will provide information on the etiology of anemia that will inform short-term policy decisions, especially for case-specific nutrition-sensitive interventions, and that will contribute to long-term policy decisions for comprehensive nutrition intervention programs.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Other
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children at the age of 6 to 59 months in each randomly selected eligible household of the Amhara or SNNPR or Somali regions of Ethiopia were the study population for this study but, during the baseline survey, we found children 6 to 53 months to retain the same child at the endline survey below five years old.
Key inclusion criteria (1 listed)
- Children 6-53 months during the baseline survey and who have stayed more than 6 months in the selected household of the Amhara or SNNPR or Somali regions of Ethiopia and have no plan to move from the study area during the study period
Key exclusion criteria (4 listed)
- Children older than the youngest child between 6-53 months of age (If more than one eligible child is in the Household) during the baseline survey.
- Children with severe illness
- Guests
- If participants lose their willingness to participate in this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of anemia among preschool children in selected regions of Ethiopia in the two different (Post and Pre harvest) seasons?
Time frame: From November 2021 to September 2022
Blood hemoglobin level below 11mg/dL
1 secondary outcome
Factors contributing to anemia anemia among preschool children in selected regions of Ethiopia in the two different (Post and Pre harvest) seasons?
Time frame: From November 2021 to September 2022
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 29 Nov 2022.
- Results publicationAnemia prevalence among preschool children in 2016 is 57%. EDHS, "Ethiopian Demography and Health Survey 2016, Central Statistical Agency (CSA).," Addis Ababa, Ethiopia, 2016.
- Individual participant dataSharing planned: Undecided. Individual Participant Data (IPD) can be shared upon request and signing of an agreement between the Ethiopian Public Health Institute and the interested party.
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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.
Barbara J Stocker, Prof study chair
Oklahoma State University
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 Oklahoma State University 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 1 inclusion and 4 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 29 Nov 2022. 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?
Prevalence of anemia among preschool children in selected regions of Ethiopia in the two different (Post and Pre harvest) seasons? (time frame: From November 2021 to September 2022). 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 NCT05626647, 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 29 Nov 2022; AzTrials last refreshed its copy on 8 Nov 2026.