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Ferrous sulfate effective for pediatric iron-deficiency anemia
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Infants and children aged 9 months to 4 years with nutritional iron-deficiency anemia had a greater increase in hemoglobin concentration at 12 weeks with ferrous sulfate than iron polysaccharide complex, according to a randomized clinical trial published in JAMA.
Iron-deficiency anemia in infants and young children — most commonly the result of excessive consumption of cow’s milk or prolonged breastfeeding without appropriate iron supplementation — affected more than 1 billion people worldwide in 2010, including up to 3% of children aged 1 to 2 years in the United States. It typically occurs in children who grow quickly and can result in irritability, malaise, pica and short- and long-term neurodevelopmental impairment.
Ferrous sulfate, an iron salt, is the standard treatment for nutritional iron-deficiency anemia. However, iron polysaccharide complex (NovaFerrum, Gensavis Pharmaceuticals) — which contains ferric iron — can be an alternative because of potential improvements in tolerability and taste.
“Treatment failure is common due to medication nonadherence, adverse effects related to excessive dosing and lack of evidence-based management guidelines,” Jacquelyn M. Powers, MD, MS, assistant professor in the department of pediatrics and section of hematology/oncology at Baylor College of Medicine, and colleagues wrote. “Few randomized clinical trials inform the selection of iron preparation, dosing schedule and duration of therapy, irrespective of the underlying etiology, age or sex of the affected individual.”
Powers and colleagues evaluated whether an iron polysaccharide complex agent more effectively increased hemoglobin concentration than ferrous sulfate in 80 infants and children aged 9 to 48 months (median age, 22 months; 55% male; 61% Hispanic white) with nutritional iron-deficiency anemia.
Researchers randomly assigned the children to 3 mg/kg of elemental iron once daily as either ferrous sulfate drops (n = 40) or iron polysaccharide complex drops (n = 40) for 12 weeks between September 2013 and November 2015.
Parents or caregivers received instructions to give daily doses at bedtime, refrain from mixing doses with any food or drink, and avoid milk intake within 1 hour of administering the study medication. Researchers also advised parents and caregivers to limit cow milk intake to a maximum of 600 mL per day.
Change in hemoglobin at 12 weeks served as the primary endpoint. Secondary endpoints included complete resolution of iron-deficiency anemia, changes in serum ferritin level and total iron-binding capacity, and adverse effects.
Twelve-week follow-up ended in January 2016.
Fifty-nine participants completed the trial — 28 from the ferrous sulfate group and 31 from the iron polysaccharide complex group.
From baseline to 12 weeks, mean hemoglobin increased from 7.9 g/dL to 11.9 g/dL in the ferrous sulfate group and from 7.7 g/dL to 11.1 g/dL in the iron polysaccharide complex group, for a greater difference of 1 g/dL (95% CI, 0.4-1.6; P < .001) with ferrous sulfate.
A greater proportion of infants and children reached a complete resolution of iron-deficiency anemia in the ferrous sulfate group than the iron polysaccharide group (29% vs. 6%; P = .04). Median serum ferritin level increased from 3 ng/mL to 15.6 ng/mL in the ferrous sulfate group and from 2 ng/mL to 7.5 ng/mL in the iron polysaccharide complex group, for a greater difference of 10.2 ng/mL (95% CI, 6.2-14.1; P < .001) with ferrous sulfate.
Mean total of iron-binding capacity decreased from 501 µg/dL to 389 µg/dL with ferrous sulfate compared with 506 µg/dL to 417 µg/dL with iron polysaccharide complex, for a greater difference of –50 µg/dL (95% CI, –86 to –14; P < .001) with ferrous sulfate.
Diarrhea occurred more frequently with iron polysaccharide complex than ferrous sulfate (58% vs. 35%; P = .04).
Researchers noted that 50% of parents and caregivers reported difficulty administering iron polysaccharide complex compared with 65% in the ferrous sulfate group.
Limitations of the study included its conduction at a single tertiary care children’s hospital and a disproportionate representation of lower income and minority patients with severe anemia, approximately 23% of whom required a blood transfusion prior to enrollment.
“These results should help stimulate the conduct of further clinical trials evaluating lower or less-frequent dosing of oral iron,” Powers and colleagues wrote. “Anticipated outcomes might include improved patient adherence, as well as enhanced iron absorption, leading to a more favorable hematologic response.” – by Chuck Gormley
Disclosure: Gensavis Pharmaceuticals funded this study. The researchers report no relevant financial disclosures.
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