NCT05669209

Brief Summary

The goal of this observational study is to assess the causes of anemia in women of reproductive age. The main questions it aims to answer are:

  • What are the causes of anemia among women of reproductive age?
  • What is the contribution of iron deficiency to overall anemia?
  • What is the prevalence of hemoglobinopathies among women of reproductive age with anemia? Participants will be asked to respond to the interview questions, and provide blood, urine, and stool samples.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
881

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 4, 2022

Completed
12 days until next milestone

Study Start

First participant enrolled

December 16, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 30, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 3, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 3, 2023

Completed
Last Updated

September 7, 2023

Status Verified

September 1, 2023

Enrollment Period

2 months

First QC Date

December 4, 2022

Last Update Submit

September 5, 2023

Conditions

Keywords

EtiologyAnemiaHemoglobinWomen of reproductive age

Outcome Measures

Primary Outcomes (2)

  • Anemia prevalence

    Anemia is diagnosed when the hemoglobin concentration test result is less than 12g/dl.

    Single blood sample collected for the cross-sectional baseline study throughout a month on average.

  • Iron deficiency anemia

    Iron deficiency anemia is diagnosed when serum ferritin concentration is less than 15μg/L and hemoglobin concentration is less than 12g/dl.

    Single blood sample collected for the cross-sectional baseline study throughout a month on average

Secondary Outcomes (1)

  • Socioeconomic Status (SES)

    From the cross-sectional baseline study conducted throughout a month on average

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe participants are expected to have the same gender identity as their biological sex.
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Women of reproductive age who are living in Kebribeyah district are the target population for this study. All non-pregnant women in the age range of 18-49 years living in three selected kebeles within the Kebribeyah district will be the study population. Our sample will be selected by systematic random sampling from a list of eligible women in the sampling frame. When there are two eligible women in the same household, one woman will be selected randomly.

You may qualify if:

  • age range 18-49 years
  • Permanent resident in the selected kebele (have lived for at least six months) in the kebele (village).

You may not qualify if:

  • Women below or above the age range 18-49 years
  • All pregnant women
  • Women who are severely ill and incapacitated.
  • Non-permanent resident women in the kebele (village)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ethiopian Public Health Institute

Addis Ababa, 1242, Ethiopia

Location

Related Publications (11)

  • Cintron-Garcia J, Guddati AK. Effect of immigration on mortality trends in sickle cell patients. Am J Blood Res. 2020 Oct 15;10(5):172-178. eCollection 2020.

    PMID: 33224561BACKGROUND
  • Daru J, Colman K, Stanworth SJ, De La Salle B, Wood EM, Pasricha SR. Serum ferritin as an indicator of iron status: what do we need to know? Am J Clin Nutr. 2017 Dec;106(Suppl 6):1634S-1639S. doi: 10.3945/ajcn.117.155960. Epub 2017 Oct 25.

    PMID: 29070560BACKGROUND
  • Gebreegziabher T, Stoecker BJ. Iron deficiency was not the major cause of anemia in rural women of reproductive age in Sidama zone, southern Ethiopia: A cross-sectional study. PLoS One. 2017 Sep 12;12(9):e0184742. doi: 10.1371/journal.pone.0184742. eCollection 2017.

    PMID: 28898272BACKGROUND
  • Kassebaum NJ, Jasrasaria R, Naghavi M, Wulf SK, Johns N, Lozano R, Regan M, Weatherall D, Chou DP, Eisele TP, Flaxman SR, Pullan RL, Brooker SJ, Murray CJ. A systematic analysis of global anemia burden from 1990 to 2010. Blood. 2014 Jan 30;123(5):615-24. doi: 10.1182/blood-2013-06-508325. Epub 2013 Dec 2.

    PMID: 24297872BACKGROUND
  • Kibret KT, Chojenta C, D'Arcy E, Loxton D. Spatial distribution and determinant factors of anaemia among women of reproductive age in Ethiopia: a multilevel and spatial analysis. BMJ Open. 2019 Apr 4;9(4):e027276. doi: 10.1136/bmjopen-2018-027276.

    PMID: 30948614BACKGROUND
  • Khambalia AZ, Aimone AM, Zlotkin SH. Burden of anemia among indigenous populations. Nutr Rev. 2011 Dec;69(12):693-719. doi: 10.1111/j.1753-4887.2011.00437.x.

    PMID: 22133195BACKGROUND
  • Kohne E. Hemoglobinopathies: clinical manifestations, diagnosis, and treatment. Dtsch Arztebl Int. 2011 Aug;108(31-32):532-40. doi: 10.3238/arztebl.2011.0532. Epub 2011 Aug 8.

    PMID: 21886666BACKGROUND
  • Liyew AM, Teshale AB. Individual and community level factors associated with anemia among lactating mothers in Ethiopia using data from Ethiopian demographic and health survey, 2016; a multilevel analysis. BMC Public Health. 2020 May 24;20(1):775. doi: 10.1186/s12889-020-08934-9.

    PMID: 32448212BACKGROUND
  • Lopez A, Cacoub P, Macdougall IC, Peyrin-Biroulet L. Iron deficiency anaemia. Lancet. 2016 Feb 27;387(10021):907-16. doi: 10.1016/S0140-6736(15)60865-0. Epub 2015 Aug 24.

    PMID: 26314490BACKGROUND
  • Petry N, Olofin I, Hurrell RF, Boy E, Wirth JP, Moursi M, Donahue Angel M, Rohner F. The Proportion of Anemia Associated with Iron Deficiency in Low, Medium, and High Human Development Index Countries: A Systematic Analysis of National Surveys. Nutrients. 2016 Nov 2;8(11):693. doi: 10.3390/nu8110693.

    PMID: 27827838BACKGROUND
  • Teshale AB, Tesema GA, Worku MG, Yeshaw Y, Tessema ZT. Anemia and its associated factors among women of reproductive age in eastern Africa: A multilevel mixed-effects generalized linear model. PLoS One. 2020 Sep 11;15(9):e0238957. doi: 10.1371/journal.pone.0238957. eCollection 2020.

    PMID: 32915880BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

We will collect blood, urine, and stool samples from all study participants. We will analyze for genetic causes of anemia (hemoglobinopathies) from the blood samples collected.

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Masresha Tessema, PhD

    Ethiopian Public Health Institute (EPHI)

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher for nutrition

Study Record Dates

First Submitted

December 4, 2022

First Posted

December 30, 2022

Study Start

December 16, 2022

Primary Completion

February 3, 2023

Study Completion

February 3, 2023

Last Updated

September 7, 2023

Record last verified: 2023-09

Locations