Maternal Anemia in Pregnancy, Before BirthPhase 3NCT06536153
Maternal Under-nutrition and Effect of Amaranth Grain Flat-bread on Anemia
A Phase 3 study testing Amaranth grain flat bread in people with Maternal Anemia in Pregnancy, Before Birth and Maternal; Malnutrition, Affecting Fetus, run by Hawassa University.
Trial summary
Introduction: In Ethiopia, maternal malnutrition is a severe public health issue. Underweight and anaemia are the two most common nutritional problems in pregnant women, and they often coexist. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maternal Anemia in Pregnancy, Before Birth, Maternal; Malnutrition, Affecting Fetus
- What is being tested?
- Amaranth grain flat bread
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 306 participants
- Where
- No sites listed yet
- Study dates
- 10 Aug 2024to 10 Jan 2025
- Phase
- Phase 3
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women less than 3 months of gestational age and residing in the district for at least 6 months.
Who cannot join
- Women who have a severe illness during the data collection period
- Women who have a psychiatric disorder
- Women who have plan to change residence during the implementation of an intervention
- Women who have chronic diseases like tuberculosis, HIV/AIDS, and cancer
- women who received blood transfusion in the last 6 months
- Women who have had malaria at least 3 times in the last 3 months
- Women with severe anemia (<7 g/dl) detected during the survey
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Maternal Under-nutrition and Effect of Amaranth Grain Flat-bread on Anemia in Northern Zone of Sidama Region, Ethiopia.
Introduction: In Ethiopia, maternal malnutrition is a severe public health issue. Underweight and anaemia are the two most common nutritional problems in pregnant women, and they often coexist.
Methods: A community-based cross-sectional study will be undertaken on a sample of 528 pregnant women in their first trimester to investigate the prevalence of anemia and associated risk factors, as well as the prevalence of co-existing anemia and undernutrition. Following that, a six-month parallel-group community-based randomized controlled trial will be conducted among 306 anemic women to assess the effect of locally prepared amaranth grain flatbread on hemoglobin concentration and anemia prevalence when compared to maize bread, which is commonly consumed among pregnant women.
Read the detailed description
Introduction: In Ethiopia, maternal malnutrition is a major public health concern. Underweight and anaemia are the two most common nutritional disorders in pregnant women, and they frequently co-exist. A prevalent kind of nutritional anaemia is iron-deficiency anaemia (IDA). These issues are primarily caused by a lack of important micro and macronutrients in the diet, as pregnant women eat primarily cereal-based foods. As a result, the burden of under-nutrition in Ethiopia necessitates a more in-depth investigation of underused crops that are high in nutrients and have the potential to minimize food and nutrition insecurity. Although the amaranth plant grows widely in Ethiopia and can boost food intake, its nutritional potential has yet to be acknowledged by community consumers and health professionals.
Methods: A community-based cross-sectional study will be conducted on a sample of 528 pregnant women in their first trimester to examine the prevalence of anemia and identify its risk factors and determine the prevalence of co-existing anemia and under-nutrition among pregnant women. From pregnant women who will be diagnosed for anemia, C-reactive protein (CRP) and serum ferritin will be analyzed to determine IDA. Following this, a parallel-group community-based randomized controlled trial will be conducted for six months among 306 anemic women to evaluate the effect of locally prepared amaranth grain flat-bread on hemoglobin concentration and anemia prevalence compared to the frequently consumed maize bread among pregnant women. A multi-stage sampling method will be utilized to select eligible pregnant women. The households with pregnant women will be identified by conducting the house-to-house census.For categorical variables, summary measures will be presented as absolute frequencies and percentages, but for numerical variables, the mean with standard deviation (SD) will be utilized as a descriptive measure after the distribution is checked for normality. A multi-level mixed-effect logistic/linear regression model will be used to account for between and with cluster effects. We will be used intention-to-treat analyses approach.
- Being tested
- Amaranth grain flat bread
- Keywords
- Pregnant women, Undernutrition, Anemia, Amaranth grain, Sidama region, Ethiopia
- Medical subject headings
- Malnutrition, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amaranth grain flat breadCombination product
The recipe will be produced according to the recommended dietary allowance (RDA); based on RDA, 200 g of flat-bread (30% chickpea and 70% amaranth grain) comprised 30 mg of iron, which can satisfy 50% of RDA supposing 15-20% iron absorption (54). A prior study concluded that the acceptability was satisfactory in the community (55). Also, a study from the Hawassa University Department of Food Sciences reported that amaranth-grain flat-bread was safe for consumption for 48 hours after preparation and improved the nutritional values (56). To lower the phytate levels in the amaranth grain, home-level processing will be used. For 24 hours, amaranth grain will be soaked in water with 5 milliliters of lemon juice per 100 milliliters of water, and it will germinate for 72 hours. It will be sun-dried, roasted, and ground using a nearby electrical mill before fermented bread is made
| Study group | Role | What they receive |
|---|---|---|
| Amaranth arm | Experimental | The pregnant women in the experimental group will be referred as the "amaranth arm". Pregnant women in the intervention arm (N = 153) will receive 200 g of flat-bread on a daily basis, comprising 30% chickpea and 70% amaranth grain in mass, for six months. Receives: Combination Product: Amaranth grain flat bread |
| Maize arm | Active comparator | The pregnant women in the control group will be referred as the "maize arm". Pregnant women in the control arm (N = 153) will receive 200 g of bread on a daily basis, comprising 100% maize, for six months. Receives: Combination Product: Amaranth grain flat bread |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of anemia
In pregnancy, anemia is defined as Hemoglobin <11 g/dl and is classified into three categories based on WHO criteria: mild (10.0-10.9 g/dl), moderate (7.0-9.9 g/dl), and severe (7.0 g/dl)
Measured: Up to six months
Prevalence of under-nutrition
In this study, the MUAC measurements of pregnant mothers who fall below a cutoff point of 23 cm will be classified as undernourished, while those who measure 23 cm or more will be classified as normal.
Measured: Up to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start10 Aug 2024 (estimated)
- Primary completion10 Jan 2025 (estimated)
- Study completion10 Jan 2025 (estimated)
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 Maternal Anemia in Pregnancy, Before BirthStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Both bi-variable and multivariable analyses using multilevel mixed effects modified Poisson models with random effects will be carried out if the outcome variable prevalence is greater than 20%. If the prevalence is less than 20%, a multilevel mixed effects binary logistic regression model will be utilized to adjust for between- and within-cluster variation for adjusted analysis.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 306 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hawassa University
- Sponsor type
- University, hospital or other
- Collaborators
- Nestlé Foundation
- Responsible party
- Principal investigator, Amanuel Yoseph Samago, Hawassa University
- Investigators
- Amanuel Yo Samago, Masters, Principal investigator, Hawassa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06536153
- Sponsor's protocol ID
- IRB/027/16
- Status last verified
- Jul 2024
- First submitted
- 26 Jul 2024
- Last updated
- 2 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: SPSS data set will be shared during publication
Publications
Mussie L, Belayneh M, Guillen-Grima F, Yoseph A. Adherence, safety, bioavailability, and acceptability of amaranth grain flatbread during pregnancy: evidence from a cluster randomized trial in Sidama region, Ethiopia. BMC Nutr. 2026 Apr 7;12(1):92. doi: 10.1186/s40795-026-01315-2.
PubMed 41947250
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Under-nutrition and Effect of Amaranth Grain Flat-bread on Anemia in Northern Zone of Sidama Region, Ethiopia.
- ClinicalTrials.gov ID
- NCT06536153
- Acronym / sponsor ID
- IRB/027/16
- Keywords
- Pregnant women, Undernutrition, Anemia, Amaranth grain, Sidama region, Ethiopia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 306 participants (estimated)
- Lead sponsor
- Hawassa UniversityUniversity, hospital or other
- Collaborators
- Nestlé Foundation
- Study start
- 10 Aug 2024 (estimated)
- Primary completion
- 10 Jan 2025 (estimated)
- Study completion
- 10 Jan 2025 (estimated)
- First posted
- 2 Aug 2024 (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.
Introduction: In Ethiopia, maternal malnutrition is a severe public health issue. Underweight and anaemia are the two most common nutritional problems in pregnant women, and they often coexist.
Methods: A community-based cross-sectional study will be undertaken on a sample of 528 pregnant women in their first trimester to investigate the prevalence of anemia and associated risk factors, as well as the prevalence of co-existing anemia and undernutrition. Following that, a six-month parallel-group community-based randomized controlled trial will be conducted among 306 anemic women to assess the effect of locally prepared amaranth grain flatbread on hemoglobin concentration and anemia prevalence when compared to maize bread, which is commonly consumed among pregnant women.
Detailed description
Introduction: In Ethiopia, maternal malnutrition is a major public health concern. Underweight and anaemia are the two most common nutritional disorders in pregnant women, and they frequently co-exist. A prevalent kind of nutritional anaemia is iron-deficiency anaemia (IDA). These issues are primarily caused by a lack of important micro and macronutrients in the diet, as pregnant women eat primarily cereal-based foods. As a result, the burden of under-nutrition in Ethiopia necessitates a more in-depth investigation of underused crops that are high in nutrients and have the potential to minimize food and nutrition insecurity. Although the amaranth plant grows widely in Ethiopia and can boost food intake, its nutritional potential has yet to be acknowledged by community consumers and health professionals.
Methods: A community-based cross-sectional study will be conducted on a sample of 528 pregnant women in their first trimester to examine the prevalence of anemia and identify its risk factors and determine the prevalence of co-existing anemia and under-nutrition among pregnant women. From pregnant women who will be diagnosed for anemia, C-reactive protein (CRP) and serum ferritin will be analyzed to determine IDA. Following this, a parallel-group community-based randomized controlled trial will be conducted for six months among 306 anemic women to evaluate the effect of locally prepared amaranth grain flat-bread on hemoglobin concentration and anemia prevalence compared to the frequently consumed maize bread among pregnant women. A multi-stage sampling method will be utilized to select eligible pregnant women. The households with pregnant women will be identified by conducting the house-to-house census.For categorical variables, summary measures will be presented as absolute frequencies and percentages, but for numerical variables, the mean with standard deviation (SD) will be utilized as a descriptive measure after the distribution is checked for normality. A multi-level mixed-effect logistic/linear regression model will be used to account for between and with cluster effects. We will be used intention-to-treat analyses approach.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Both bi-variable and multivariable analyses using multilevel mixed effects modified Poisson models with random effects will be carried out if the outcome variable prevalence is greater than 20%. If the prevalence is less than 20%, a multilevel mixed effects binary logistic regression model will be utilized to adjust for between- and within-cluster variation for adjusted analysis.
| Arm | Type | Receives |
|---|---|---|
| Amaranth arm | Experimental | Combination Product: Amaranth grain flat breadThe pregnant women in the experimental group will be referred as the "amaranth arm". Pregnant women in the intervention arm (N = 153) will receive 200 g of flat-bread on a daily basis, comprising 30% chickpea and 70% amaranth grain in mass, for six months. |
| Maize arm | Active comparator | Combination Product: Amaranth grain flat breadThe pregnant women in the control group will be referred as the "maize arm". Pregnant women in the control arm (N = 153) will receive 200 g of bread on a daily basis, comprising 100% maize, for six months. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Pregnant women less than 3 months of gestational age and residing in the district for at least 6 months.
Key exclusion criteria (7 listed)
- Women who have a severe illness during the data collection period
- Women who have a psychiatric disorder
- Women who have plan to change residence during the implementation of an intervention
- Women who have chronic diseases like tuberculosis, HIV/AIDS, and cancer
- women who received blood transfusion in the last 6 months
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 |
|---|---|---|
| Amaranth grain flat breadThe recipe will be produced according to the recommended dietary allowance (RDA); based on RDA, 200 g of flat-bread (30% chickpea and 70% amaranth grain) comprised 30 mg of iron, which can satisfy 50% of RDA supposing 15-20% iron absorption (54). A prior study concluded that the acceptability was satisfactory in the community (55). Also, a study from the Hawassa University Department of Food Sciences reported that amaranth-grain flat-bread was safe for consumption for 48 hours after preparation and improved the nutritional values (56). To lower the phytate levels in the amaranth grain, home-level processing will be used. For 24 hours, amaranth grain will be soaked in water with 5 milliliters of lemon juice per 100 milliliters of water, and it will germinate for 72 hours. It will be sun-dried, roasted, and ground using a nearby electrical mill before fermented bread is made | Combination product | Amaranth arm, Maize arm |
Primary outcome
Prevalence of anemia
Time frame: Up to six months
In pregnancy, anemia is defined as Hemoglobin <11 g/dl and is classified into three categories based on WHO criteria: mild (10.0-10.9 g/dl), moderate (7.0-9.9 g/dl), and severe (7.0 g/dl)
Prevalence of under-nutrition
Time frame: Up to six months
In this study, the MUAC measurements of pregnant mothers who fall below a cutoff point of 23 cm will be classified as undernourished, while those who measure 23 cm or more will be classified as normal.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2024.
- Derived from this study: PubMed 41947250Mussie L, Belayneh M, Guillen-Grima F, Yoseph A. Adherence, safety, bioavailability, and acceptability of amaranth grain flatbread during pregnancy: evidence from a cluster randomized trial in Sidama region, Ethiopia. BMC Nutr. 2026 Apr 7;12(1):92. doi: 10.1186/s40795-026-01315-2.
- Individual participant dataSharing planned: No. SPSS data set will be shared during publication
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.
Amanuel Yo Samago, Masters principal investigator
Hawassa University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Amaranth grain flat bread in people with Maternal Anemia in Pregnancy, Before Birth and Maternal; Malnutrition, Affecting Fetus, run by Hawassa University.
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 7 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: status not confirmed, as of the sponsor's last update on 2 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Embialle MI Beyene, PhD (+251929285443, embialle@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of anemia (time frame: Up to six months). 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 NCT06536153, 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 2 Aug 2024; AzTrials last refreshed its copy on 26 Oct 2026.