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AnemiaNCT05669209

Causes of Anemia Among Women of Reproductive Age

An observational study of Anemia, run by Ethiopian Public Health Institute at 1 site in Ethiopia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 49 years, women only
Conditions the study is for
Anemia
How many people
881 participants
Where
1 siteEthiopia
Study dates
16 Dec 2022to 3 Feb 2023
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 18 to 49 years
  • Women only
  • No healthy volunteers
  • Adult

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.

Who may be able to join

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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Ethiopia1 site

  • Ethiopian Public Health Institute

    Addis Ababa, 1242

Other trials in Ethiopia

About this study

Official title: Etiology and Contributing Factors of Anemia Among Women of Reproductive Age at Kebribeyah District in the Somali Regional State, Ethiopia

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.

Read the detailed description

One-third of the global population is affected by anemia making it one of the major public health problems at the global level. Women of reproductive age are at risk for anemia. The prevalence of anemia reported in 2016 Ethiopian Demographic and Health Survey (EDHS) is a moderate public health problem at the national level, but it is a severe public health problem in the Somali regional state among women of reproductive age (WRA). The purpose of this study is to assess the etiology and determinant factors of anemia among women of reproductive age. A cross-sectional design will be employed for the current study. In the current study, the investigators will assess the causes and contributing factors for anemia and their relationship with anemia. Women of reproductive age 18-49 years old residing in the Kebribeyah district are the target population for this study. The sample size determined for the current study is 881. The Somali region was selected for the current study due to its highest prevalence of anemia (60.6%%) among women of reproductive age according to the EDHS 2016. Kerbribeyah district was selected from the Somali regional state. Simple random sampling was employed to select three kebeles (villages) from the available kebeles with no other nutrition interventions in the Kebribeyah district. Two enumerations areas (EAs) from each of the three kebeles will be selected by simple random sampling. The sample size determined will be allocated to three kebeles and two EAs within the Kebeles on probability proportional to size (PPS). The study participants will be selected by systematic random sampling from a list of participants in a sampling frame obtained by house-to-house listing. After obtaining written informed consent, the data will be collected from the selected participant in their homes. All study participants who take part in the current study will be interviewed. They will also provide blood, urine, and stool samples. The prevalence of anemia and iron status biomarkers are the primary outcomes for the current study. The participants will be tested for anemia by measuring hemoglobin concentration. In addition, a complete blood count (CBC) test will be done for all study participants. The current study will fill the evidence gap by identifying major causes and contributors to overall anemia among women of reproductive age in the Kebribeyah district. The researchers anticipate that determining the causes of anemia will be a crucial first step in tackling the high prevalence of anemia among women of reproductive age in the Somali regional state and beyond.

Conditions
Anemia
Keywords
Etiology, Anemia, Hemoglobin, Women of reproductive age
Medical subject headings
Anemia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Anemia prevalence

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

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

  2. 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.

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

Secondary outcomes (1)

  1. Socioeconomic Status (SES)

    Socioeconomic status will be assessed by using principal component analysis (PCA) from socio-demographic information collected.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Dec 2022
  2. Study start16 Dec 2022
  3. Primary completion3 Feb 2023
  4. Study completion3 Feb 2023

Resources

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
Cross-sectional
Enrolment
881 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05669209
Sponsor's protocol ID
EPHI_IRB_410_2021_1
Status last verified
Sep 2023
First submitted
4 Dec 2022
Last updated
7 Sep 2023
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 agreement between Ethiopian Public Health Institute and the interested party.

Publications

  • 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.

    PubMed 33224561

  • 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.

    PubMed 29070560

  • 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.

    PubMed 28898272

  • 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.

    PubMed 24297872

  • 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.

    PubMed 30948614

  • 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.

    PubMed 22133195

  • 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.

    PubMed 21886666

  • 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.

    PubMed 32448212

  • 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.

    PubMed 26314490

  • 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.

    PubMed 27827838

  • 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.

    PubMed 32915880

Questions about this trial

What is this clinical trial studying?

An observational study of Anemia, run by Ethiopian Public Health Institute 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 2 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 7 Sep 2023. 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 prevalence (time frame: Single blood sample collected for the cross-sectional baseline study throughout a month on average.). The study lists 2 primary outcomes in all. 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 NCT05669209, which also lists 11 linked publications.

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 7 Sep 2023; AzTrials last refreshed its copy on 8 Nov 2026.

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