Evidence map›Paper›PMID 27101422›Full record

Trial reportEuropean journal of drug metabolism and pharmacokinetics2017

Randomized Open-Label Phase 1 Study of the Pharmacokinetics of Ferric Maltol in Inflammatory Bowel Disease Patients with Iron Deficiency.

Bernd Bokemeyer, Annette Krummenerl, Christian Maaser, Stefanie Howaldt, Michael Mroß, Nick Mallard

Abstract readClinical Trial, Phase IRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in European journal of drug metabolism and pharmacokinetics, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
0.5field-weighted citation impact, top 32% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 14 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Review
  4. Review
  5. Review
  6. Review
  7. Review
  8. Review
  9. Observational
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 5 institutions in 2 countries.

Bernd BokemeyerGastroenterology Practice Minden, Uferstr. 3, 32423, Minden, Germany. bernd.bokemeyer@t-online.de.
Annette KrummenerlKrankenhaus Martha-Maria Halle-Dölau, Klinik für Innere Medizin I, Halle (Saale), Germany.
Christian MaaserStädtisches Klinikum Lüneburg, Ambulanzzentrum Gastroenterologie am Klinikum Lüneburg, Lüneburg, Germany.
Stefanie HowaldtSchwerpunktpraxis CED, Hamburg, Germany.
Michael MroßGastroenterologische Schwerpunktpraxis, Berlin, Germany.
Nick MallardClinical Development, Shield TX (UK) Limited, Gateshead, UK.
Gateshead Health NHS Foundation Trust · GBJohannes Wesling Klinikum Minden · DEKlinikum Lüneburg · DEMartha-Maria Hospital · DEPraxis für Hämatologie und Onkologie · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIron deficiency anemia (IDA) is a common complication of inflammatory bowel disease (IBD). Oral ferric maltol improves and normalizes hemoglobin (Hb) in patients with IBD.

aimThis open-label, randomized Phase 1 study evaluated the pharmacokinetics of ferric maltol and its effect on iron indices in IBD patients with iron deficiency (with or without anemia).

methodsIron deficient adult IBD patients received ferric maltol 30, 60, or 90 mg twice daily during an 8-day period. Pharmacokinetics and iron uptake were assessed on days 1 and 8.

resultsTwenty-four patients were included: 13 with Crohn's disease and 11 with ulcerative colitis (mean age 39 years; 67 % female, mean Hb 13.0 g/dL; mean reticulocyte Hb content (CHr) 31.9 pg; mean ferritin 13.9 µg/L). Plasma maltol and maltol glucuronide increased rapidly at all doses, reaching maximum plasma concentration (C

conclusionsThe key constituents of ferric maltol showed predictable pharmacokinetics, with no accumulation over 7 days and increased iron uptake and storage over time at 30-90 mg twice-daily doses.

Indexed as

AdultAnemia, Iron-DeficiencyArea Under CurveColitis, UlcerativeCrohn DiseaseDose-Response Relationship, DrugFemaleFerric CompoundsGlucuronidesHemoglobinsHumansMaleMiddle AgedProspective StudiesPyronesTime FactorsFerric Compoundsferric maltolGlucuronidesHemoglobinsPyrones

Identifiers

PMID27101422
OpenAlexW2341106933

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.