PMID- 37205968
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20230521
IS  - 2691-171X (Electronic)
IS  - 2691-171X (Linking)
VI  - 2
IP  - 3
DP  - 2021 Aug
TI  - Safety, Tolerability, and Pharmacokinetics of Oral Ferric Maltol in Children With 
      Iron Deficiency: Phase 1 Study.
PG  - e090
LID - 10.1097/PG9.0000000000000090 [doi]
AB  - Iron deficiency is common in children and can have negative effects on behavior 
      and function. Standard oral ferrous iron replacement is poorly absorbed and can 
      cause treatment-limiting gastrointestinal adverse events (AEs). Ferric maltol is 
      formulated to improve gastrointestinal absorption and tolerability versus oral 
      ferrous compounds. In adult phase 3 trials, it increased hemoglobin and iron 
      stores versus placebo, with a gastrointestinal AE profile similar to placebo. 
      Here, we assess different doses of ferric maltol in children with iron 
      deficiency. METHODS: This phase 1 trial involved children of age 10 to 17 years 
      with ferritin <30 microg/L (or <50 microg/L with transferrin saturation [TSAT] <20%). 
      Children were randomized 1:1:1 to oral ferric maltol 7.8 mg, 16.6 mg, or 30 mg 
      twice daily for 9 days and once on day 10. The primary outcomes were iron uptake 
      measures (serum iron and TSAT) and population pharmacokinetic analyses. RESULTS: 
      The trial included 37 children (mean age 14.0 years; baseline mean +/- standard 
      deviation ferritin 16.3 +/- 8.02 microg/L). Ferric maltol increased iron uptake 
      nondose-proportionally: serum iron and TSAT plateaued between the 2 higher doses 
      on day 1 and were comparable across all doses on day 10. Twenty children (54%) 
      experienced AEs (all mild/moderate, gastrointestinal 32%), with similar 
      frequencies in each group. CONCLUSIONS: All 3 ferric maltol doses increased iron 
      uptake in children with iron deficiency, even over the short study duration, and 
      were well tolerated. Nondose-dependent changes in serum iron and TSAT indicate 
      physiologic regulation of iron uptake to meet the body's needs.
CI  - Copyright (c) The Author(s). Published by Wolters Kluwer on behalf of European 
      Society for Pediatric Gastroenterology, Hepatology, and Nutrition and North 
      American Society for Pediatric Gastroenterology, Hepatology, and Nutrition.
FAU - Allen, Stephen
AU  - Allen S
AD  - From the Department of Clinical Sciences, Liverpool School of Tropical Medicine, 
      Liverpool, UK.
AD  - Department of Paediatric Gastroenterology, Hepatology and Nutrition, Alder Hey 
      Children's NHS Foundation Trust, Liverpool, UK.
FAU - Auth, Marcus Karl-Heinz
AU  - Auth MK
AD  - Department of Paediatric Gastroenterology, Hepatology and Nutrition, Alder Hey 
      Children's NHS Foundation Trust, Liverpool, UK.
AD  - Faculty of Health and Life Sciences, University of Liverpool, Liverpool, UK.
FAU - Kim, Jon Jin
AU  - Kim JJ
AD  - Department of Paediatric Nephrology, Nottingham Children's Hospital, Nottingham, 
      UK.
FAU - Vadamalayan, Babu
AU  - Vadamalayan B
AD  - Paediatric Gastroenterology and Nutrition Service, King's College Hospital NHS 
      Foundation Trust, London, UK.
LA  - eng
PT  - Journal Article
DEP - 20210615
PL  - United States
TA  - JPGN Rep
JT  - JPGN reports
JID - 101773885
PMC - PMC10191551
OTO - NOTNLM
OT  - anemia
OT  - children
OT  - iron deficiency
OT  - iron-replacement therapy
COIS- Dr Allen has served as chair or member of data monitoring and safety boards for 
      clinical trials of novel antimalarials for MMV Medicines for Malaria Venture, 
      Switzerland, Shin Poong Pharma Co. Ltd., Korea, and Novartis Pharma AG, 
      Switzerland, and for antiviral therapy for Ark Biosciences, Pty Ltd., Australia. 
      Dr Kim has received speaker fees from Sandoz Ltd. Dr Allen has received research 
      funding from MRC, NIHR, UKAid, Wellcome Trust, EPSRC, Children's Investment Fund 
      Foundation, and Crohn's and Colitis UK. Dr Auth has received funding from Dr Falk 
      Pharma and Nutricia. Dr Kim has received research funding from Chiesi Ltd. The 
      remaining authors report no conflicts of interest.
EDAT- 2021/06/15 00:00
MHDA- 2021/06/15 00:01
PMCR- 2021/06/15
CRDT- 2023/05/19 15:34
PHST- 2021/02/14 00:00 [received]
PHST- 2021/04/20 00:00 [accepted]
PHST- 2021/06/15 00:01 [medline]
PHST- 2021/06/15 00:00 [pubmed]
PHST- 2023/05/19 15:34 [entrez]
PHST- 2021/06/15 00:00 [pmc-release]
AID - 10.1097/PG9.0000000000000090 [doi]
PST - epublish
SO  - JPGN Rep. 2021 Jun 15;2(3):e090. doi: 10.1097/PG9.0000000000000090. eCollection 
      2021 Aug.