Among children with nutritional iron-deficiency anemia (IDA), those who received treatment with ferrous sulfate had higher hemoglobin concentrations at 12 weeks than those who received iron polysaccharide complex.
Jacquelyn M. Powers, MD, MS, from Baylor College of Medicine, Houston, Texas, and colleagues published the results of their double-blind, randomized clinical trial online June 13 in JAMA.
"Once daily, low-dose ferrous sulfate should be considered for children with nutritional iron-deficiency anemia," the authors write.
IDA is a common type of anemia, affecting millions of people worldwide. In the United States, it is estimated to affect up to 3% of children aged 1 to 2 years and has been associated with neurodevelopmental delays. In young children, IDA typically results from nutritional deficiency due to excessive milk intake and/or prolonged breastfeeding without adequate iron supplementation.
Although many iron salt preparations are available for IDA treatment, ferrous sulfate is the most commonly prescribed oral formulation. However, iron polysaccharide complex preparations are potentially better tolerated and taste better.
The researchers designed the study to examine whether an iron polysaccharide complex was more effective than ferrous sulfate in improving the hemoglobin concentration in infants and young children with nutritional IDA.
They conducted the trial at a single site and included 59 infants and children aged 9 to 48 months (55% male) with nutritional IDA. The primary outcome was change in hemoglobin concentration during 12 weeks. Secondary outcomes included complete resolution of IDA, changes in serum ferritin level and total iron-binding capacity, and adverse effects.
Children received a single daily dose of elemental iron as oral ferrous sulfate drops (15 mg/mL) or oral iron polysaccharide complex drops (15 mg/mL).
From baseline to 12 weeks, mean hemoglobin concentrations increased more in children who received ferrous sulfate (from 7.9 g/dL to 11.9 g/dL) than in those who received iron polysaccharide complex (from 7.7 g/dL to 11.1 g/dL), representing a significant difference of 1.0 g/dL (95% confidence interval [CI], 0.4 - 1.6; P < .001) with ferrous sulfate treatment.
Also in the ferrous sulfate group, IDA completely resolved in more children (29% vs 6%; P = .04); median serum ferritin level increased more, from 3.0 to 15.6 ng/mL compared with 2.0 to 7.5 ng/mL in the iron polysaccharide complex group (difference, 10.2 ng/mL; 95% CI, 6.2 - 14.1 ng/mL; P < .001); mean total iron-binding capacity decreased more, from 501 to 389 μg/dL compared with 506 to 417 μg/dL in the iron polysaccharide complex group (difference, −50 μg/dL; 95% CI, −86 to −14 μg/dL; P < .001); and diarrhea occurred less frequently (35% vs 58%; P = .04) in the ferrous sulfate group.
The authors acknowledge the limitations of this trial, including that it was conducted at a single tertiary care children's hospital. They also recognize that the findings may not be generalizable to the general pediatric population because the clinical trial setting involved strict monitoring, which would not occur in standard community practice.
Nevertheless, they emphasize that, unlike most previous therapeutic studies involving oral iron agents, this trial was designed as a double-blind, randomized controlled trial.
"In concert with other literature, these results should help stimulate the conduct of further clinical trials evaluating lower or less frequent dosing of oral iron," the authors conclude.
This study was supported by grants from Gensavis Pharmaceuticals LLC; the National Center for Advancing Translational Sciences; and the National Heart, Lung, and Blood Institute. The authors have disclosed no relevant financial relationships.
JAMA. Published online June 13, 2017. Abstract
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Cite this: Ferrous Sulfate Effective for Iron-Deficiency Anemia in Kids - Medscape - Jun 14, 2017.