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Effect of Low-Dose Ferrous Sulfate vs Iron Polysaccharide Complex on Hemoglobin Concentration in Young Children With
Jacquelyn M Powers1, George R Buchanan2, Leah Adix3
1Division of Hematology and Oncology, Baylor College of Medicine, Houston, Texas2Department of Pediatrics, Baylor College of Medicine, Houston, Texas3Texas Children's Hospital, Houston.
Insights
Ferrous sulfate significantly increased hemoglobin levels in children with iron-deficiency anemia compared to iron polysaccharide complex. Ferrous sulfate is recommended for treating pediatric iron-deficiency anemia due to its efficacy and tolerability.
Area of Science:
- Pediatric Hematology
- Nutritional Anemia Research
- Clinical Trial Analysis
Background:
- Iron-deficiency anemia (IDA) is a global health concern, particularly impacting neurodevelopment in children.
- Ferrous sulfate is a common treatment, but iron polysaccharide complex may offer better tolerability.
Purpose of the Study:
- To compare the efficacy of ferrous sulfate versus iron polysaccharide complex in improving hemoglobin concentration in infants and children with nutritional IDA.
Main Methods:
- A 12-week, double-blind, randomized superiority trial involving 80 children aged 9-48 months with nutritional IDA.
- Participants received either ferrous sulfate or iron polysaccharide complex at 3 mg/kg/day of elemental iron.
- Primary outcome was the change in hemoglobin concentration; secondary outcomes included IDA resolution and adverse effects.
Main Results:
- Ferrous sulfate led to a significantly greater increase in hemoglobin (1.0 g/dL difference, P < .001) compared to iron polysaccharide complex.
- Complete resolution of IDA was higher with ferrous sulfate (29% vs 6%, P = .04).
- Ferrous sulfate also showed greater improvements in serum ferritin and total iron-binding capacity, with fewer reports of diarrhea.
Conclusions:
- Ferrous sulfate is more effective than iron polysaccharide complex in increasing hemoglobin levels in children with nutritional IDA.
- Low-dose, once-daily ferrous sulfate should be considered as a primary treatment for pediatric nutritional IDA.
- Ferrous sulfate demonstrated superior efficacy and comparable or better tolerability in this pediatric population.
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.
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