دورية أكاديمية
Effect of Low-Dose Ferrous Sulfate vs Iron Polysaccharide Complex on Hemoglobin Concentration in Young Children With Nutritional Iron-Deficiency Anemia: A Randomized Clinical Trial.
| العنوان: | Effect of Low-Dose Ferrous Sulfate vs Iron Polysaccharide Complex on Hemoglobin Concentration in Young Children With Nutritional Iron-Deficiency Anemia: A Randomized Clinical Trial. |
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| المؤلفون: | Powers JM; Division of Hematology and Oncology, Baylor College of Medicine, Houston, Texas2Department of Pediatrics, Baylor College of Medicine, Houston, Texas3Texas Children's Hospital, Houston., Buchanan GR; Division of Hematology and Oncology, University of Texas Southwestern Medical Center, Dallas5Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas6Children's Health, Dallas, Texas., Adix L; Children's Health, Dallas, Texas., Zhang S; Department of Clinical Sciences, University of Texas Southwestern Medical Center, Dallas., Gao A; Department of Clinical Sciences, University of Texas Southwestern Medical Center, Dallas., McCavit TL; Division of Hematology and Oncology, Cook Children's Medical Center, Ft Worth, Texas9Department of Pediatrics, Cook Children's Medical Center, Ft Worth, Texas. |
| المصدر: | JAMA [JAMA] 2017 Jun 13; Vol. 317 (22), pp. 2297-2304. |
| نوع المنشور: | Journal Article; Randomized Controlled Trial |
| اللغة: | English |
| بيانات الدورية: | Publisher: American Medical Association Country of Publication: United States NLM ID: 7501160 Publication Model: Print Cited Medium: Internet ISSN: 1538-3598 (Electronic) Linking ISSN: 00987484 NLM ISO Abbreviation: JAMA Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: Chicago : American Medical Association, 1960- |
| مواضيع طبية MeSH: | Anemia, Iron-Deficiency/*blood , Anemia, Iron-Deficiency/*drug therapy , Child Nutrition Disorders/*complications , Ferrous Compounds/*pharmacology , Hemoglobin A/*drug effects , Iron Compounds/*pharmacology , Polysaccharides/*pharmacology, Anemia, Iron-Deficiency/etiology ; Child, Preschool ; Double-Blind Method ; Female ; Ferritins/blood ; Ferrous Compounds/administration & dosage ; Ferrous Compounds/adverse effects ; Hemoglobin A/metabolism ; Humans ; Infant ; Iron/metabolism ; Iron Compounds/administration & dosage ; Iron Compounds/adverse effects ; Lost to Follow-Up ; Male ; Medication Adherence/statistics & numerical data ; Polysaccharides/administration & dosage ; Polysaccharides/adverse effects ; Treatment Outcome |
| مستخلص: | 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. |
| التعليقات: | Comment in: JAMA. 2017 Oct 3;318(13):1282. (PMID: 28973242) |
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| معلومات مُعتمدة: | K23 HL132001 United States HL NHLBI NIH HHS; KL2 TR001103 United States TR NCATS NIH HHS; L40 HL129833 United States HL NHLBI NIH HHS; UL1 TR001105 United States TR NCATS NIH HHS |
| سلسلة جزيئية: | ClinicalTrials.gov NCT01904864; NCT01904864 |
| المشرفين على المادة: | 0 (Ferrous Compounds) 0 (Iron Compounds) 0 (Polysaccharides) 39R4TAN1VT (ferrous sulfate) 9007-73-2 (Ferritins) 9034-51-9 (Hemoglobin A) E1UOL152H7 (Iron) |
| تواريخ الأحداث: | Date Created: 20170614 Date Completed: 20170707 Latest Revision: 20210503 |
| رمز التحديث: | 20221213 |
| مُعرف محوري في PubMed: | PMC5815003 |
| DOI: | 10.1001/jama.2017.6846 |
| PMID: | 28609534 |
| قاعدة البيانات: | MEDLINE |
| تدمد: | 1538-3598 |
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| DOI: | 10.1001/jama.2017.6846 |