Effectiveness of Amaranth Grain Flatbread Compared to Maize Bread for Iron Deficiency Anemia among Pregnant Women: Findings from a Cluster Randomized Controlled Trial in Southern Ethiopia

Background/Objectives: Maternal anemia remains a critical public health issue in Ethiopia, with iron deficiency anemia (IDA) being the most prevalent form, primarily due to low dietary iron intake and poor bioavailability from cereal-based diets. Despite the widespread cultivation of nutrient-rich amaranth in Ethiopia, its role in improving maternal iron status remains understudied. To address this gap, we conducted a cluster-randomized controlled trial to evaluate the effectiveness of amaranth grain flatbread consumption, compared to maize bread consumption, on hemoglobin concentration and IDA among pregnant women in southern Ethiopia. Methods: We conducted a six-month, community-based, parallel-group, cluster-randomized controlled trial involving 306 pregnant women with anemia (mild or moderate) to evaluate the effectiveness of locally prepared amaranth grain flatbread in enhancing hemoglobin concentration and reducing IDA, compared to the standard maize bread. At the end of the intervention, hemoglobin levels were measured, and IDA was assessed using World Health Organization (WHO) defined cutoffs of serum ferritin levels. Multilevel linear and modified Poisson regression models were used to estimate adjusted effects, accounting for confounders and community-level clustering. All analyses were conducted following the intention-to-treat principle. Results: The loss to follow-up rate was similar between the amaranth and maize groups (4.6% vs. 3.9%). In the unadjusted analysis, the mean hemoglobin concentration was higher in the amaranth group (12.39 g/dL, 95% CI: 12.17–12.61) compared to the maize group (10.17 g/dL, 95% CI: 9.95–10.39). The proportion of IDA was also lower in the amaranth group (26.71% 95% CI: 20.14–34.49 vs. 65.98% 95% CI: 57.93–73.21). After adjusting for potential confounders (due to baseline differences after randomization) and clustering, pregnant women who received amaranth grain flatbread had higher hemoglobin levels (adjusted β = 2.67 g/dL; 95% CI: 2.41–2.90) and a 53% lower risk of IDA compared to those in the maize group (adjusted risk ratio = 0.47; 95% CI: 0.26–0.84). No serious adverse events were reported in either group. Conclusion: Consumption of amaranth grain flatbread during pregnancy improved hemoglobin levels and reduced IDA compared to maize-based diets. These findings highlight the potential of locally available, nutrient-dense foods, such as amaranth, to address maternal iron deficiency among pregnant women with mild or moderate anemia in resource-limited settings. Trial registration number: NCT06536153