Botanic Healthcare’s Ironnox improves iron levels in women with anemia, clinical trial finds
Key takeaways
- Botanic Healthcare’s randomized clinical trial in 60 women with iron-deficiency anemia found that Ironnox improved iron levels compared to ferric pyrophosphate.
- No gastrointestinal adverse effects, a common side effect in iron supplements, were reported in the Ironnox group, indicating potential tolerability benefits.
- The company says the findings suggest Ironnox may be a more tolerable option for improving iron status in people with iron-deficiency anemia.
Botanic Healthcare has announced new clinical findings for its iron ingredient Ironnox — a liposomal ferric pyrophosphate. The trial also showed no gastrointestinal-related adverse events from supplementation, a common issue with iron supplementation.
“Iron supplementation should not be a compromise between efficacy and tolerability. Our clinical findings with Ironnox demonstrate the potential of advanced delivery technology to improve key markers of iron status while maintaining favorable gastrointestinal tolerability,” says Gaurav Soni, co-founder and managing director of Botanic Healthcare.
Iron deficiency affects many US adults, including people who do not have anemia, heart failure, or chronic kidney disease, and are not pregnant. It has previously been identified as a common public health problem that needs improved screening.
The randomized clinical trial has not yet been published. The company details that the trial lasted for 56 days and included 60 women who all had iron-deficient anemia.
Improved iron levels
In comparison to ferric pyrophosphate, the group supplementing with Ironnox showed 7.2% higher hemoglobin levels and 41.8% higher ferritin levels. They also had 18.8% higher transferrin saturation and an 18% lower fatigue score.
No one in the supplementation group reported any gastrointestinal adverse effects, while 20% of participants in the group consuming ferric pyrophosphate reported these issues.
To treat iron-deficiency anemia, clinicians typically prescribe oral iron supplements, which may cause an upset stomach.To treat iron-deficiency anemia, clinicians typically prescribe oral iron supplements. However, these can leave behind excess iron that causes inflammation and an upset stomach.
Madhu Krishnamani, co-founder and managing director of Botanic Healthcare, comments on the new trial: “These results strengthen our commitment to developing clinically researched nutritional ingredients that address important challenges in iron supplementation.”
Dr. H.N. Shivaprasad, chief scientific officer at Botanic Healthcare, adds: “The clinical findings demonstrate improvements across key markers of iron status, supporting the potential of liposomal delivery for iron supplementation.”
He says the study has provided important evidence supporting the performance of liposomal ferric pyrophosphate.
“Our Caco-2 permeability data demonstrated 2.1-fold higher permeability for liposomal ferric pyrophosphate compared with conventional ferric pyrophosphate, providing additional in vitro supporting evidence for the liposomal delivery approach.”
