Benefits
Oral iron that raises haemoglobin at 30 mg a day
In iron-deficient adults, 30 to 60 mg a day raised haemoglobin over 4 to 12 weeks. In head-to-head trials it did about as well as intravenous iron or other oral iron for haemoglobin, not better. In a 56-person comparison in inflammatory bowel disease, 8.7 percent on sucrosomial iron reported side effects against 30.3 percent on iron polymaltose, and 1 stopped against 4. That comparison was not randomized.
An oral option when the alternative is an infusion
In a randomized open-label trial in 99 adults with non-dialysis kidney disease and low iron, 30 mg a day reached the same haemoglobin at 3 months as 1000 mg of intravenous iron gluconate, with significantly fewer side effects. Intravenous iron worked faster, refilled stores better and held haemoglobin steady after treatment stopped, while on oral iron it fell back to baseline.
Tested in people who cannot tolerate iron salts
In 52 adults with inflammatory bowel disease who had not tolerated, or not responded to, iron salts, 30 mg a day for 12 weeks raised mean haemoglobin by about 0.5 g/dL; 5 stopped early because of side effects. In 30 adults with mild anaemia and the same bowel conditions, haemoglobin rose in 86 percent, though 9 still had digestive events. Neither study had a control group.
Tested in iron-deficient blood donors
Fifty regular whole-blood donors in Austria who had fallen below the haemoglobin cut-off for donating took 30 mg/day for 90 to 120 days. Among the 47 who finished, median haemoglobin rose 0.94 g/dL and median ferritin 4.97 ng/mL, standardised to 90 days of intake, with almost no digestive complaints. There was no control group, so part of that change may be recovery that would have happened anyway.
Tested in women after childbirth
Sixty women in Romania with mild or moderate anaemia after delivery took 30 mg a day (60 mg a day for the first 10 days if moderate) for 60 days; 57 finished. Haemoglobin rose 3.6 g/dL on average and 81 percent reached a normal level, but only 36 percent reached a ferritin of 30 ng/mL. There was no control group, and haemoglobin recovers on its own after childbirth.
Mechanism of action
M-cell and macrophage absorption pathway
The sucrosomial matrix is intended to protect ferric pyrophosphate from stomach acid and to avoid the DMT1 transporter, with iron proposed to enter through M-cells of Peyer's patches and gut-associated macrophages before reaching the circulation on transferrin. This route was mapped in cell-culture, ex vivo intestinal and rodent experiments, several of them run or funded by the manufacturer, and has not been confirmed in human absorption studies.
Reduced free luminal iron
Because iron is encapsulated rather than dissolved in the gut lumen, less free iron is available to interact with mucosa, microbiota, and dietary components. This is the proposed reason for the lower rates of digestive complaints reported in some trials.
Clinical trials
Pilot study of oral sucrosomial iron (30 mg elemental iron/day) for 12 weeks in adults with inflammatory bowel disease and mild iron-deficiency anemia. Endpoints: hemoglobin, ferritin, tolerability, and gastrointestinal adverse events. (Abbati et al. 2019, Internal and Emergency Medicine)
30 adults with Crohn's disease or ulcerative colitis and mild iron-deficiency anaemia; patients with severe IBD were excluded. 12 weeks, single arm, no control group.
Haemoglobin rose in 86 percent of participants (11.67 to 12.37 g/dL, p = 0.001) and all iron parameters improved. Forty-four adverse events were recorded in total, including 11 gastrointestinal events in 9 of the 30 participants (30 percent). IBD activity scores also improved, but with no comparison group that change cannot be separated from the natural course of mild disease.
Pilot study comparing oral sucrosomial iron with intravenous iron in anemic cancer patients without iron deficiency who were receiving darbepoetin alfa during chemotherapy. Endpoints: hemoglobin response, transfusion need, safety, quality of life. (Mafodda et al. 2017, Supportive Care in Cancer)
64 adults with chemotherapy-related anaemia (haemoglobin 8 to 10 g/dL) and no absolute or functional iron deficiency, all receiving darbepoetin alfa. 8 weeks, randomized.
Haemoglobin response was 70 percent on oral sucrosomial iron and 71 percent on intravenous ferric gluconate, a difference that was not statistically significant. There was no difference in transfusion need and no difference in quality of life. The oral form was better tolerated. Every participant was also taking the prescription drug darbepoetin alfa and none of them was iron-deficient, so this trial says little about ordinary supplement use. The principal investigator reported honoraria and travel reimbursement from PharmaNutra.
Randomized open-label trial of oral sucrosomial iron (60 mg/day for 8 weeks, then 30 mg/day for 4 weeks) against a single 1000 mg intravenous infusion of ferric carboxymaltose, in ulcerative colitis patients in remission with mild-to-moderate anaemia, all weighing under 70 kg. Endpoints: haemoglobin, serum iron, ferritin, gastrointestinal symptoms. (Bertani et al. 2021, Nutrients)
42 adults with ulcerative colitis in clinical, endoscopic and biochemical remission and mild-to-moderate iron-deficiency anaemia; 40 completed. 12 weeks.
42 patients were randomized and 40 analysed, 20 per arm. Haemoglobin rose about 1.1 g/dL in both arms by week 4 and stayed there, with no significant difference between them. Ferritin told a different story: at 12 weeks it stood at 26 ng/mL on sucrosomial iron against 131 ng/mL on intravenous ferric carboxymaltose (p = 0.001), a median change from baseline of 9 ng/mL against 137 ng/mL (p < 0.0001), so iron stores were not restored by the oral form. Tolerability was good on both, with one of the 20 oral patients reporting transient bloating and flatulence during the 60 mg phase. The trial was powered as a superiority comparison in 32 subjects with no pre-specified non-inferiority margin, so a non-significant result in 40 patients does not establish equivalence. PharmaNutra paid the article processing charge.