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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.

Abstract 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.
PMID
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Authors

Mayor MeshTerms
Keywords
Journal Title jama
Publication Year Start




PMID- 28609534
OWN - NLM
STAT- MEDLINE
DA  - 20170613
DCOM- 20170707
LR  - 20170707
IS  - 1538-3598 (Electronic)
IS  - 0098-7484 (Linking)
VI  - 317
IP  - 22
DP  - 2017 Jun 13
TI  - 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.
PG  - 2297-2304
LID - 10.1001/jama.2017.6846 [doi]
AB  - 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 mug/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 mug/dL (ferrous sulfate) vs
      506 to 417 mug/dL (iron complex) (a greater difference of -50 mug/dL [95% CI, -86
      to -14 mug/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.
FAU - Powers, Jacquelyn M
AU  - Powers JM
AD  - Division of Hematology and Oncology, Baylor College of Medicine, Houston,
      Texas2Department of Pediatrics, Baylor College of Medicine, Houston, Texas3Texas 
      Children's Hospital, Houston.
FAU - Buchanan, George R
AU  - Buchanan GR
AD  - 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.
FAU - Adix, Leah
AU  - Adix L
AD  - Children's Health, Dallas, Texas.
FAU - Zhang, Song
AU  - Zhang S
AD  - Department of Clinical Sciences, University of Texas Southwestern Medical Center,
      Dallas.
FAU - Gao, Ang
AU  - Gao A
AD  - Department of Clinical Sciences, University of Texas Southwestern Medical Center,
      Dallas.
FAU - McCavit, Timothy L
AU  - McCavit TL
AD  - Division of Hematology and Oncology, Cook Children's Medical Center, Ft Worth,
      Texas9Department of Pediatrics, Cook Children's Medical Center, Ft Worth, Texas.
LA  - eng
SI  - ClinicalTrials.gov/NCT01904864
GR  - K23 HL132001/HL/NHLBI NIH HHS/United States
PT  - Journal Article
PT  - Randomized Controlled Trial
PL  - United States
TA  - JAMA
JT  - JAMA
JID - 7501160
RN  - 0 (Ferrous Compounds)
RN  - 0 (Iron Compounds)
RN  - 0 (Polysaccharides)
RN  - 39R4TAN1VT (ferrous sulfate)
RN  - 9007-73-2 (Ferritins)
RN  - 9034-51-9 (Hemoglobin A)
RN  - E1UOL152H7 (Iron)
SB  - AIM
SB  - IM
MH  - Anemia, Iron-Deficiency/*blood/*drug therapy/etiology
MH  - Child Nutrition Disorders/*complications
MH  - Child, Preschool
MH  - Double-Blind Method
MH  - Female
MH  - Ferritins/blood
MH  - Ferrous Compounds/administration & dosage/adverse effects/*pharmacology
MH  - Hemoglobin A/*drug effects/metabolism
MH  - Humans
MH  - Infant
MH  - Iron/metabolism
MH  - Iron Compounds/administration & dosage/adverse effects/*pharmacology
MH  - Lost to Follow-Up
MH  - Male
MH  - Medication Adherence/statistics & numerical data
MH  - Polysaccharides/administration & dosage/adverse effects/*pharmacology
MH  - Treatment Outcome
EDAT- 2017/06/14 06:00
MHDA- 2017/07/08 06:00
CRDT- 2017/06/14 06:00
AID - 2631530 [pii]
AID - 10.1001/jama.2017.6846 [doi]
PST - ppublish
SO  - JAMA. 2017 Jun 13;317(22):2297-2304. doi: 10.1001/jama.2017.6846.