Phase 2 trial shows iron hydroxide adipate tartrate (IHAT) is non-inferior to ferrous sulfate (FeSO4) in correcting iron deficiency and hemoglobin response, with a lower incidence of moderate-severe diarrhea.
New data demonstrated the importance of developing safe and effective treatments for iron deficiency anemia (IDA) in young children, particularly in Sub-Saharan Africa and other areas where the condition is prevalent.1
The findings indicated that iron hydroxide adipate tartrate (IHAT) was a safe, effective alternative to the well-established therapy ferrous sulfate (FeSO4), which effectively increases the body's iron, but can also cause adverse events like constipation and nausea.
Iron deficiency anemia is one of the leading causes of disability in Sub-Saharan Africa. This phase 2 study conducted in The Gambia aimed to assess the efficacy and safety of the novel iron supplement for the treatment of IDA in children under 3 years of age.
The study investigators, including Nuredin Mohammed, MD, Medical Research Council Unit The Gambia at the London School of Hygiene & Tropical Medicine, Banjul, Gambia, stated that the findings could have significant implications for the treatment of iron deficiency anemia, not only in the study region, but others areas where the condition is a public health concern.
After analyzing the results, investigators observed that IHAT was non-inferior to FeSO4 in terms of iron deficiency correction and hemoglobin response. 28.2% of children who received IHAT achieved the primary efficacy endpoint, compared with 22.1% of those who were treated with FeSO4.
Additionally, results showed IHAT had a lower incidence of moderate-severe diarrhea than FeSO4, with no increased adverse events in comparison with placebo. The prevalence of moderate-severe diarrhea was similar across all 3 groups, with 21.2% of children in the IHAT group, 23.7% in the FeSO4 group, and 20.5% in the placebo group developing at least one episode of moderate-severe diarrhea over the 85 days of intervention.
The incidence density of moderate-severe diarrhea was 2.66 in the IHAT group and 3.42 in the FeSO4 group, indicating that IHAT had a lower incidence of diarrhea than FeSO4.
The randomized, double-blind, parallel, placebo-controlled, non-inferiority trial included a total of 642 children with iron deficiency anemia aged 6-35 months. Participating patients were randomly assigned to receive either IHAT, ferrous sulfate (FeSO4), or a placebo, daily for three months.
The primary efficacy endpoint was the composite of hemoglobin response at day 85 and correction of iron deficiency. The primary safety endpoint was moderate-severe diarrhea analyzed as incidence density and prevalence over the three-month intervention.
Secondary endpoints included hospitalization, acute respiratory infection, malaria, treatment failures, iron handling markers, inflammatory markers, longitudinal prevalence of diarrhea, and incidence density of bloody diarrhea.
The team recommended a future investigation into iron hydroxide adipate tartrate in a definitive phase III trial. With further research and development, IHAT has the potential to become an important tool in the fight against IDA and health complications associated with it, they stated.