Benefits
Hemoglobin in pregnant women with low iron, compared with iron salts
In an 80-woman trial at 100 mg twice a day for 90 days, hemoglobin rose 2.16 g/dL vs 1.93 g/dL on ferrous sulfate, with no significant difference, and ferritin ended higher (179 vs 157 ng/mL). In a 150-woman trial at 100 mg a day, day 90 hemoglobin and ferritin did not differ from ferrous sulfate or ferrous ascorbate. The maker's data sheet calls pregnancy studies inconclusive.
Stomach complaints compared with ferrous sulfate
In pooled adult trials, adverse reactions were reported by 14.9% on this complex vs 34.1% on ferrous sulfate, and in two pregnancy trials by 29% vs 56% and 31% vs 78%. In 57 women with low stores the gap was small (28% vs 33% symptom rate), and a pooled analysis in children found no difference.
Blood count recovery in adults compared with ferrous sulfate
Across six adult trials, hemoglobin after 8 to 13 weeks was similar to ferrous sulfate at equal doses, though the maker's data sheet reports faster normalization on ferrous sulfate. Refilling stores lagged: ferritin was lower with this complex where reported, and in 57 women with low stores ferritin rose 109% on ferrous sulfate but did not change on this complex over 12 weeks.
Hemoglobin compared with other forms in children
A pooled analysis of six trials in children found a smaller hemoglobin rise than with ferrous sulfate (0.81 g/dL less), and a 125-child trial found a smaller rise than with ferrous ascorbate (3.33 vs 4.88 g/dL). One 103-child trial found no significant hemoglobin difference and fewer stomach complaints (26.9% vs 50.9%).
Results against placebo in schoolchildren
In 591 schoolchildren with mild anemia in a malaria area of Indonesia, about 6 mg/kg a day for 8 weeks did not raise hemoglobin or ferritin more than placebo, and malaria parasites appeared more often on iron among children whose stores were already full. Only about a quarter had low stores at entry.
Mechanism of action
Ferric iron held in a large, stable carbohydrate complex
The complex is a polynuclear iron(III)-hydroxide core held by polymaltose, about 55 kD in size. It stays soluble across a broad pH range and releases little free iron. Per its datasheet it diffuses through the gut lining about 40 times less than soluble ferrous salts, and its iron is taken up by an active process.
Slow uptake with little free iron in the blood
Serum iron barely rises in the first hours after a dose, so blood iron curves do not reflect how much is used. In 10 healthy men, 100 mg of iron as ferrous sulfate raised non-transferrin-bound iron, a loosely held form, while iron polymaltose did not differ from water.
Taken with meals, and absorbed more when stores are low
Unlike ferrous salts, which are usually advised on an empty stomach, this complex is labeled to be taken during or right after a meal; food did not lower its absorption in the maker's studies. As with other iron forms, the share absorbed is higher when iron deficiency is greater and falls as the dose rises.
Clinical trials
Exploratory, open-label, randomized, multicenter study of Maltofer® or ferrous sulfate, each 100 mg iron twice daily (200 mg a day) for 90 days; primary end point was the change in hemoglobin to days 60 and 90; indexed as receiving non-government research support, but the sponsor, any company ties and any registry number are not stated in the abstract (Ortiz et al. 2011, J Matern Fetal Neonatal Med)
80 pregnant women with hemoglobin of 10.5 g/dL or less, ferritin of 15 ng/mL or less and small red cells (MCV below 80 fL); lead site in Colombia.
The primary end point did not differ: hemoglobin rose 2.16 g/dL on iron polymaltose vs 1.93 g/dL on ferrous sulfate by day 90 (not significant). Ferritin at day 90 was 179 vs 157 ng/mL (P = 0.014). Adverse events affected 12 of 41 (29.3%) vs 22 of 39 (56.4%), P = 0.015.
Randomized, double-blind, parallel-group 8-week trial of iron polymaltose complex (100 mg iron) vs ferrous sulfate (120 mg iron) daily; aims were efficacy, safety, compliance and cost; funding not described in the abstract (Saha et al. 2007, MedGenMed)
100 pregnant women aged 20 to 40 at 14 to 27 weeks in Chandigarh, India, with hemoglobin below 9 g/dL and ferritin below 12 mcg/L.
Hemoglobin, red cell indices, serum iron and ferritin rose significantly within both groups; the abstract gives no between-group hemoglobin figures. Adverse effects were less common on iron polymaltose (15 women, 31%, vs 41 women, 78%; P < .001), pill-count compliance was 91% vs 87% (P < .05), and total cost was comparable.
Single-center, randomized, open-label 90-day trial: ferrous ascorbate 100 mg iron with 1.5 mg folic acid once daily, ferrous sulfate 60 mg iron twice daily with 5 mg folic acid, or iron polymaltose 100 mg iron once daily; Emcure Pharmaceuticals gifted the ferrous ascorbate and polymaltose products; authors declared no conflicts (Chavan et al. 2021, Indian J Med Res)
177 pregnant women in New Delhi at 12 to 26 weeks with hemoglobin 7 to 9.9 g/dL and ferritin near 9 mcg/L; 150 analyzed.
Hemoglobin at day 90 was 11.3 g/dL on ferrous ascorbate vs 10.99 g/dL on ferrous sulfate (P < 0.05), with no difference at days 30 and 60 and none vs iron polymaltose. Ferritin rose to 31.8, 28.6 and 30.4 mcg/L, not different between groups. Adverse effects affected 42% vs 62% vs 46%; only epigastric pain differed (9 vs 15 women on ferrous sulfate).
Single-blind randomized trial (ACTRN12623000529640) of ferrous sulfate (105 mg iron) with sodium ascorbate vs iron(III)-hydroxide polymaltose complex (100 mg iron) daily for 12 weeks; aims were efficacy (ferritin) and tolerability; supported by Western Australian government health funds (per Europe PMC); authors reported no conflicts (McKay et al. 2026, Clin Nutr)
Women in Australia with serum ferritin below 50 mcg/L in three cohorts (athletes, premenopausal and postmenopausal women); 57 completed.
Ferritin rose 109% on ferrous sulfate (P < 0.001) but did not change on the polymaltose complex (+7%, P = 0.727), a significant supplement by time interaction; results did not differ between cohorts. The symptom rate was lower on the complex (28% vs 33%, P < 0.001). Compliance was 94.9%.
Review and meta-analysis using Cochrane methods of comparative trials at equivalent doses; primary end point was hemoglobin after about 2 months, safety was the share with adverse drug reactions; funding not stated in the abstract, the second author's affiliation is not given, and it appeared in the same journal issue as a review by a Vifor employee (Toblli et al. 2007, Arzneimittelforschung)
Adults with iron-deficiency anemia in six comparative trials (one double-blind): 319 on iron polymaltose and 238 on ferrous sulfate; four pediatric trials were excluded for baseline differences.
Hemoglobin at 8 to 13 weeks was 12.13 vs 11.94 g/dL (weighted mean difference 0.01 g/dL, 95% CI -0.23 to 0.21). Where reported, ferritin was lower with iron polymaltose. Adverse reactions occurred in 14.9% vs 34.1% (P < 0.001), mainly upper digestive complaints, stained teeth and diarrhea.
Systematic review and random-effects meta-analysis of randomized trials comparing the oral polymaltose complex with standard oral salts in children; authors declared no competing interests (Mohd Rosli et al. 2021, PeerJ)
493 randomized children in eight trials of treatment or prevention of low stores; six trials (368 children) compared the complex with ferrous sulfate for treatment.
Hemoglobin rose less on the polymaltose complex than on ferrous sulfate (mean difference -0.81 g/dL, 95% CI -1.08 to -0.53; high certainty), and serum storage levels were lower (mean difference -21.24; 3 trials, moderate certainty). Side effects did not differ (3 trials, 274 children). Comparisons with gluconate and bisglycinate could not be settled.
Randomized controlled trial at a government teaching hospital; both groups received 6 mg/kg elemental iron a day for 3 months; blinding not described in the abstract; authors declared no conflicts (Patil et al. 2019, Indian J Pediatr)
125 children aged 1 to 12 in Aurangabad, India, with clinical signs of anemia from low stores.
Hemoglobin rose more on ferrous ascorbate at 1 month (3.13 vs 2.0 g/dL, P = 0.017) and 3 months (4.88 vs 3.33 g/dL, P = 0.001), with faster early rises in reticulocytes and red cell size. Minor adverse reactions occurred on ferrous ascorbate and none on polymaltose complex.
Placebo-controlled randomized trial (ISRCTN 83091970, registered retrospectively), with participants and laboratory staff blinded, of Maltofer® at about 6 mg/kg elemental iron a day, 6 days a week for 8 weeks; primary outcomes were malaria parasites by microscopy and PCR, with hemoglobin and ferritin secondary; funded by the Nutricia Research Foundation; authors declared no competing interests (Prasetyani et al. 2017, Malar J)
591 schoolchildren aged 5 to 18 on Flores, Indonesia, with mild anemia and no malaria parasites at entry (294 on the complex, 297 on placebo); 26.9% had serum storage levels below 30 mcg/L.
The complex did not raise hemoglobin or serum storage levels more than placebo. Malaria parasites seen by microscopy appeared more often on the complex (hazard ratio 2.2, 95% CI 1.2 to 4.0), an excess confined to children with full stores; PCR positivity at week 16 did not differ (16.6% vs 14.3%).