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Ferrous sulfate oral solution in young children with iron deficiency anemia: An open-label trial of efficacy, safety, and acceptability.
- Source :
-
Pediatrics international : official journal of the Japan Pediatric Society [Pediatr Int] 2020 Jul; Vol. 62 (7), pp. 820-827. Date of Electronic Publication: 2020 Jul 09. - Publication Year :
- 2020
-
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).<br />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.<br />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).<br />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.<br /> (© 2020 The Authors. Pediatrics International published by John Wiley & Sons Australia, Ltd on behalf of Japan Pediatric Society.)
- Subjects :
- Administration, Oral
Child, Preschool
Drug Combinations
Female
Ferritins blood
Ferrous Compounds adverse effects
Hemoglobins analysis
Humans
Infant
Male
Mucins adverse effects
Treatment Outcome
Anemia, Iron-Deficiency drug therapy
Ferrous Compounds administration & dosage
Mucins administration & dosage
Subjects
Details
- Language :
- English
- ISSN :
- 1442-200X
- Volume :
- 62
- Issue :
- 7
- Database :
- MEDLINE
- Journal :
- Pediatrics international : official journal of the Japan Pediatric Society
- Publication Type :
- Academic Journal
- Accession number :
- 32191814
- Full Text :
- https://doi.org/10.1111/ped.14237