[Skip to Content]
[Skip to Content Landing]
Views 1,303
Citations 0
Original Investigation
June 13, 2017

Effect of Low-Dose Ferrous Sulfate vs Iron Polysaccharide Complex on Hemoglobin Concentration in Young Children With Nutritional Iron-Deficiency AnemiaA Randomized Clinical Trial

Author Affiliations
  • 1Division of Hematology and Oncology, Baylor College of Medicine, Houston, Texas
  • 2Department of Pediatrics, Baylor College of Medicine, Houston, Texas
  • 3Texas Children’s Hospital, Houston
  • 4Division of Hematology and Oncology, University of Texas Southwestern Medical Center, Dallas
  • 5Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas
  • 6Children’s Health, Dallas, Texas
  • 7Department of Clinical Sciences, University of Texas Southwestern Medical Center, Dallas
  • 8Division of Hematology and Oncology, Cook Children’s Medical Center, Ft Worth, Texas
  • 9Department of Pediatrics, Cook Children’s Medical Center, Ft Worth, Texas
JAMA. 2017;317(22):2297-2304. doi:10.1001/jama.2017.6846
Key Points

Question  Is iron polysaccharide complex more effective than ferrous sulfate in improving the hemoglobin concentration in infants and young children with nutritional iron-deficiency anemia?

Findings  In this double-blind, randomized clinical trial that included 80 patients, those who received ferrous sulfate for 12 weeks had a 1.0 g/dL greater increase in hemoglobin concentration than those receiving iron polysaccharide complex.

Meaning  Among infants and young children with nutritional iron-deficiency anemia, ferrous sulfate compared with iron polysaccharide complex resulted in a greater increase in hemoglobin concentration at 12 weeks.

Abstract

Importance  Iron-deficiency anemia (IDA) affects millions of persons worldwide, and is associated with impaired neurodevelopment in infants and children. Ferrous sulfate is the most commonly prescribed oral iron despite iron polysaccharide complex possibly being better tolerated.

Objective  To compare the effect of ferrous sulfate with iron polysaccharide complex on hemoglobin concentration in infants and children with nutritional IDA.

Design, Setting, and Participants  Double-blind, superiority randomized clinical trial of infants and children aged 9 to 48 months with nutritional IDA (assessed by history and laboratory criteria) that was conducted in an outpatient hematology clinic at a US tertiary care hospital from September 2013 through November 2015; 12-week follow-up ended in January 2016.

Interventions  Three mg/kg of elemental iron once daily as either ferrous sulfate drops or iron polysaccharide complex drops for 12 weeks.

Main Outcomes and Measures  Primary outcome was change in hemoglobin over 12 weeks. Secondary outcomes included complete resolution of IDA (defined as hemoglobin concentration >11 g/dL, mean corpuscular volume >70 fL, reticulocyte hemoglobin equivalent >25 pg, serum ferritin level >15 ng/mL, and total iron-binding capacity <425 μg/dL at the 12-week visit), changes in serum ferritin level and total iron-binding capacity, adverse effects.

Results  Of 80 randomized infants and children (median age, 22 months; 55% male; 61% Hispanic white; 40 per group), 59 completed the trial (28 [70%] in ferrous sulfate group; 31 [78%] in iron polysaccharide complex group). From baseline to 12 weeks, mean hemoglobin increased from 7.9 to 11.9 g/dL (ferrous sulfate group) vs 7.7 to 11.1 g/dL (iron complex group), a greater difference of 1.0 g/dL (95% CI, 0.4 to 1.6 g/dL; P < .001) with ferrous sulfate (based on a linear mixed model). Proportion with a complete resolution of IDA was higher in the ferrous sulfate group (29% vs 6%; P = .04). Median serum ferritin level increased from 3.0 to 15.6 ng/mL (ferrous sulfate) vs 2.0 to 7.5 ng/mL (iron complex) over 12 weeks, a greater difference of 10.2 ng/mL (95% CI, 6.2 to 14.1 ng/mL; P < .001) with ferrous sulfate. Mean total iron-binding capacity decreased from 501 to 389 μg/dL (ferrous sulfate) vs 506 to 417 μg/dL (iron complex) (a greater difference of −50 μg/dL [95% CI, −86 to −14 μg/dL] with ferrous sulfate; P < .001). There were more reports of diarrhea in the iron complex group than in the ferrous sulfate group (58% vs 35%, respectively; P = .04).

Conclusions and Relevance  Among infants and children aged 9 to 48 months with nutritional iron-deficiency anemia, ferrous sulfate compared with iron polysaccharide complex resulted in a greater increase in hemoglobin concentration at 12 weeks. Once daily, low-dose ferrous sulfate should be considered for children with nutritional iron-deficiency anemia.

Trial Registration  clinicaltrials.gov Identifier: NCT01904864

×