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NOT YET RECRUITING
NCT06536153
PHASE3

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

Sponsor: Hawassa University

View on ClinicalTrials.gov

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.

Official title: Maternal Under-nutrition and Effect of Amaranth Grain Flat-bread on Anemia in Northern Zone of Sidama Region, Ethiopia.

Key Details

Gender

FEMALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

306

Start Date

2024-08-10

Completion Date

2025-01-10

Last Updated

2024-08-02

Healthy Volunteers

Yes

Interventions

COMBINATION_PRODUCT

Amaranth grain flat bread

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