Maternal Under-nutrition and Effect of Amaranth Grain Flat-bread on Anemia

NCT06536153 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: IRB/027/16
• Study Type: interventional
• Target: 306
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Maternal Anemia in Pregnancy, Before Birth; Maternal; Malnutrition, Affecting Fetus

Keywords

Pregnant women; Undernutrition; Anemia; Amaranth grain; Sidama region; Ethiopia

Outcome Measures

Primary Outcomes (2)

• 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)

  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.

  Up to six months

Study Arms (2)

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.

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.

Combination Product: Amaranth grain flat bread

Interventions

Amaranth grain flat bread COMBINATION_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

Amaranth arm; Maize arm

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women less than 3 months of gestational age and residing in the district for at least 6 months.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hawassa University: lead
• Nestlé Foundation: collaborator

MeSH Terms

Conditions

Malnutrition; Anemia

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Amanuel Yo Samago, Masters

  Hawassa University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Embialle MI Beyene, PhD

CONTACT

+251929285443; embialle@yahoo.com

Amanuel Ej Debiso, Masters

CONTACT

+251916450685; aejeso@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The trial subjects, bread distributors, and outcome assessors (data collectors) will be all unaware of the study groups assignment and bread content. The bread distributers for the maize and amaranth groups will be distinct, and there will be 12 bread-distributers, one for each kebele. Twelve boxes, one for each kebele, will be packed and tagged with the name of the pregnant women. Every day, each bread-distributer fed the pregnant women at their home, under their close supervision. Unopened bread will be returned and recorded by the coordinator each day in the event of absences or refusals.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: July 26, 2024
• First Posted: August 2, 2024
• Study Start: August 10, 2024
• Primary Completion: January 10, 2025
• Study Completion: January 10, 2025
• Last Updated: August 2, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share