Table 2.
Efficacy and tolerance of oral Sucrosomial® iron in different clinical setting (9 studies, 513 patients).
| Author [ref] (year) Study Type |
Study Population |
Treatment Compound (Dose) Duration |
Baseline Hb (g/dL) |
Final Hb (g/dL) |
Baseline Ferritin (ng/mL) |
Final Ferritin (ng/mL |
Baseline TSAT (%) |
Final TSAT (%) |
GI Side Effects |
|---|---|---|---|---|---|---|---|---|---|
| Parisi et al. [60] (2017) RCT |
80 non-anemic pregnant women 12–14 week |
Control, no iron (n = 20) FS (30 mg/day) (n = 20) SI (14 mg/day) (n = 20) SI (28 mg/day) (n = 20) Up to postpartum week 6 |
12.0 11.9 12.0 11.9 |
11.6 11.8 12.0 12.0 |
47 44 52 53 |
31 43 41 50 |
28 27 28 27 |
26 27 30 29 |
|
| Mafodda et al. [51] (2017) RCT pilot |
64 patients with solid tumor | SI (30 mg/day) + DEPO (500 mcg/3 weeks) FG (125 mg/wk IV) + DEPO (500 mcg/3 weeks) 2 months |
9.4 9.2 |
12.7 12.9 |
--- |
--- |
--- |
--- |
3% 0% |
| Pisani et al. [50] (2014) RCT |
99 patients with chronic kidney disease | SI (30 mg/day) (n = 66) FG (125 mg/week IV, TID: 1000 mg) (n = 33) 3 months |
10.8 10.7 |
11.4 11.7 |
71 68 |
86 239 |
16.5 17.0 |
18.3 21.5 |
12% 18% |
| Bastida et al. [74] (2016) Case series |
46 patients with inflammatory bowel disease intolerant to FS | SI (30 mg/day) 3 months |
11.2 | 11.8 * | 14.3 | 16.0 | 8.7 | 16.2 | 11% |
| Stuklov et al. [75] (2018) Observational |
40 patients with inflammatory bowel disease | SI (60 mg/day) (n = 25) IS (100 mg/session, 500–1000 mg) (n = 15) 3 months |
10.1 10.0 |
11.8 11.8 |
--- | --- | --- | --- | No |
| Elli et al. [48] (2016) Observational |
34 patients with celiac disease | SI (30 mg/day) intolerant to FS (n = 18) FS (105 mg/day) (n = 16) 3 months |
10.0 10.0 |
12.1 12.3 |
12 (all) | --- | 11 (all) | --- | Not stated |
| Farinati et al. [78] (2018) Case series |
20 patients with autoimmune atrophic gastritis | SI (120 mg/daily, either fasting or during meals) 8 weeks |
10.5 | 12.5 | 7 | 27 | 8 | 18 | 10% |
| Ciudín et al. [49] (2017) Case-control |
40 women after bariatric surgery | SI (28 mg/day) (n = 20) IVI (Iron sucrose 300 mg) (n = 20) 3 months |
12.4 12.5 |
12.3 12.7 |
102 98 |
89 96 |
22.9 23.6 |
24.1 26.3 |
0% 0% |
| Giordano et al. [87] (2016) RCT |
90 patient with IDA due to bleeding | SI (120 mg/day) (n = 45) FG (62.5 mg/day IV to cover TID) (n = 45) 4 weeks |
8.5 8.3 |
12.0 12.5 |
5 7 |
--- | --- | --- | 26% 22% ** |
DEPO, darbepoetin; FG, ferric gluconate; FS, ferrous sulphate; GI, gastrointestinal; IBD, inflammatory bowel disease; IDA, iron deficiency anemia; IV, intravenous; PCI, percutaneous coronary intervention; RCT, randomized controlled trial; SI, Sucrosomial® iron; TID, total iron deficiency; TSAT, transferrin saturation. * Recovery from IDA: 25.7%, improvement on quality of life (EuroQoL) form 60.9 at baseline to 65.5 at the end of study period; ** Hypotension, urticaria, headache.