Ferrous sulfate oral solution in young children with iron deficiency anemia: An open‐label trial of efficacy, safety, and acceptability

Abstract

Background This study evaluated the efficacy, safety, and acceptability of a new ferrous sulfate oral solution (Tardyferon® 20 mg/mL) in young children with mild or moderate iron deficiency anemia (IDA). Methods This was a multicenter, national, single‐arm, open‐label study. Children aged 6–53 months presenting with mild or moderate IDA (i.e., blood hemoglobin (Hb) ranging from 7.0 to 10.9 g/dL and serum ferritin <12 ng/mL) were eligible for inclusion. The ferrous sulfate heptahydrate solution (2 mg/kg/day) was administered orally for 3 months. If normalization of either Hb or ferritin was not achieved at month 3 the treatment was continued for another 3 months. Results Of the 100 children screened, 21 aged 6–17 months were included and received the study treatment, and 19 were analyzed for hematologic outcomes at month 3. Only one patient continued treatment for the additional 3 months. At month 3, mean ± SD Hb and ferritin levels were 12.0 ± 0.7 g/dL and 31.5 ± 19.4 ng/mL, respectively. Hemoglobin and ferritin levels were normalized in 95% (18/19) and 84% (16/19) of the patients, respectively. Treatment compliance and levels of satisfaction of both the parents and the investigators were high. Overall, 33.3% of patients (7/21) experienced at least one adverse event. Only one patient (4.8%) experienced a drug‐related adverse event (upper abdominal pain). Conclusions A 2 mg/kg daily dose of the new oral ferrous sulfate heptahydrate solution provides substantial therapeutic benefit with high levels of tolerability in young children who have mild or moderate IDA.

Trying to Solve the Puzzle of the Interaction of Ascorbic Acid and Iron: Redox, Chelation and Therapeutic Implications

“…Of particular interest is ferrous ascorbate, which is the drug of choice for the treatment of iron deficiency anaemia, especially in developing countries like India. For example, doses of 3–6 mg/kg/day of ferrous ascorbate for 12 weeks in children have led to substantial increases in haemoglobin levels of about 4–5 g/dL, which was thus more efficient than other iron formulations including iron polymaltose and ferrous sulfate [ 189 , 190 , 191 , 192 ].…”

“…The ascorbic acid interactions with different oral, intramuscular and intravenous iron formulations are of pharmacological, toxicological and clinical importance [ 205 , 206 ]. There are many ferrous and ferric iron formulations available, such as oral ferrous sulfate, ferrous gluconate, ferric fumarate, ferric polymaltose, ferric maltol, ferric iron dextran, ferric iron sucrose, ferric gluconate, ferric saccharate, etc., used for treating many categories of iron-deficient patients [ 190 , 191 , 192 , 207 ]. While oral iron formulations may be beneficial for patients given the increase of iron absorption in the presence of ascorbic acid, there is no advantage to using vitamin C during intramuscular and intravenous administration of different iron formulations, given the increasing prospects of pro-oxidant and other toxicity [ 208 , 209 ].…”

Micronized, Microencapsulated Ferric Iron Supplementation in the Form of >Your< Iron Syrup Improves Hemoglobin and Ferritin Levels in Iron-Deficient Children: Double-Blind, Randomized Clinical Study of Efficacy and Safety

“…Hb value may normalize on a small daily dose of iron, but this low dose seldom suffices for metabolic needs or the replenishment of iron stores in the body [ 13 ]. Similar studies of iron supplementation in children have reported higher efficacies within a 3-month supplementation period; however, much higher doses of iron (ranging from 2 mg/kg of iron per body weight per day to 6 mg/kg of iron per body weight per day) than the one applied in our study have been used [ 14 , 15 , 16 ]. Of particular importance, these studies were all performed in anemic subjects, whereas our study included children with ID without anemia.…”

Iron and Chelation in Biochemistry and Medicine: New Approaches to Controlling Iron Metabolism and Treating Related Diseases

“…It has taken almost forty years to reach the clinical stage from the original discovery and from initial biochemical and other preclinical studies, which proposed the mechanisms of efficient iron delivery from iron complexes to cells, animals and humans [128][129][130][131]. Improvements have also been reported in the treatment of iron deficiency anemia using many other ferric and ferrous iron formulations and also different administration protocols [300][301][302][303].…”