NCT05626647

Brief 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. 1.What is the prevalence and etiology of anemia in the two different (Post and Pre-harvest) seasons?
  2. 2.What is the strength of the interaction between anemia and each of the determinant factors being considered?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
590

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 4, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 4, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 25, 2022

Completed
Last Updated

November 29, 2022

Status Verified

November 1, 2022

Enrollment Period

4 months

First QC Date

November 15, 2022

Last Update Submit

November 23, 2022

Conditions

Keywords

EtiologyAnemiaPreschool

Outcome Measures

Primary Outcomes (1)

  • 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

    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?

    From November 2021 to September 2022

Eligibility Criteria

Age6 Months - 59 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ethiopian Public Health Institute

Addis Ababa, Ethiopia

Location

Related Publications (1)

  • Anemia prevalence among preschool children in 2016 is 57%. EDHS, "Ethiopian Demography and Health Survey 2016, Central Statistical Agency (CSA).," Addis Ababa, Ethiopia, 2016.

    RESULT

Biospecimen

Retention: SAMPLES WITH DNA

The hemoglobinopathies test will be performed to assess the genetic alteration of the individual hemoglobin synthesis status.

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Barbara J Stocker, Prof

    Oklahoma State University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 15, 2022

First Posted

November 25, 2022

Study Start

November 1, 2021

Primary Completion

March 4, 2022

Study Completion

September 4, 2022

Last Updated

November 29, 2022

Record last verified: 2022-11

Locations