Evidence map›Paper›PMID 27932449›Full record

Trial reportJournal of Crohn's & colitis2017

Oral Iron Treatment Response and Predictors in Anaemic Adolescents and Adults with IBD: A Prospective Controlled Open-Label Trial.

David S Rampton, James R Goodhand, Neerav M Joshi, Abu-Bakarr Karim, Yasmine Koodun, Farah M Barakat, Lucia Macken, Douglas G Ward, Tariq H Iqbal, Jenny Epstein and 2 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IVControlled Clinical TrialEquivalence Trial
In one paragraph

Trial report in Journal of Crohn's & colitis, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01991314 (Treatment of Iron Deficiency Anaemia in Adults and Adolescents With Inflammatory Bowel Disease Using Ferrous Sulphate), which is not on this map. Cited by 13 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 3 pooled it
1.8field-weighted citation impact, top 13% 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.

NCT01991314 phase4completednot on this map

Treatment of Iron Deficiency Anaemia in Adults and Adolescents With Inflammatory Bowel Disease Using Ferrous Sulphate: Tolerance and Effects on Haemoglobin, Mood, Quality of Life and Fatigue

TypeinterventionalSponsorQueen Mary University of LondonRan2011 to 2015Enrolled90ConditionsUlcerative Colitis, Crohn's DiseaseArmsFerrous sulphate
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 3 syntheses or guidelines pooled it, 24 citations in OpenAlex.

  1. Guideline
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  3. Pooled it
  4. Review
  5. Review
  6. Article
  7. Article
  8. Article
  9. Review
  10. Observational
  11. Article
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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

12 authors at 3 institutions in 1 country.

David S RamptonCentre for Immunobiology, Institute of Cell and Molecular Science, Barts and the London School of Medicine and Dentistry, London,UK.
James R GoodhandCentre for Immunobiology, Institute of Cell and Molecular Science, Barts and the London School of Medicine and Dentistry, London,UK.
Neerav M JoshiCentre for Immunobiology, Institute of Cell and Molecular Science, Barts and the London School of Medicine and Dentistry, London,UK.
Abu-Bakarr KarimCentre for Immunobiology, Institute of Cell and Molecular Science, Barts and the London School of Medicine and Dentistry, London,UK.
Yasmine KoodunCentre for Immunobiology, Institute of Cell and Molecular Science, Barts and the London School of Medicine and Dentistry, London,UK.
Farah M BarakatCentre for Immunobiology, Institute of Cell and Molecular Science, Barts and the London School of Medicine and Dentistry, London,UK.
Lucia MackenCentre for Immunobiology, Institute of Cell and Molecular Science, Barts and the London School of Medicine and Dentistry, London,UK.
Douglas G WardDepartment of Gastroenterology, University Hospital Birmingham, Birmingham, UK.
Tariq H IqbalDepartment of Gastroenterology, University Hospital Birmingham, Birmingham, UK.
Jenny EpsteinDepartment of Paediatric Gastroenterology, Chelsea and Westminster Hospital, London, UK.
John M FellDepartment of Paediatric Gastroenterology, Chelsea and Westminster Hospital, London, UK.
Ian R SandersonCentre for Immunobiology, Institute of Cell and Molecular Science, Barts and the London School of Medicine and Dentistry, London,UK.
Queen Mary University of London · GBChelsea and Westminster Hospital · GBNIHR Surgical Reconstruction and Microbiology Research Centre · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBecause of previous concerns about the efficacy and safety of oral iron for treating iron deficiency anaemia in inflammatory bowel disease [IBD], particularly in young people, we compared the effects of ferrous sulphate on haemoglobin response, disease activity and psychometric scores in adolescents and adults with IBD. We also assessed the relation of baseline serum hepcidin to haemoglobin response.

methodsWe undertook a prospective, open-label, 6-week non-inferiority trial of the effects of ferrous sulphate 200 mg twice daily on haemoglobin, iron status, hepcidin, disease activity (Harvey-Bradshaw Index, Simple Colitis Clinical Activity Index, C-reactive protein [CRP]), faecal calprotectin and psychometric scores in 45 adolescents [age 13-18 years] and 43 adults [>18 years].

resultsOn intention-to-treat analysis, ferrous sulphate produced similar rises in haemoglobin in adolescents {before treatment 10.3 g/dl [0.18] (mean [SEM]), after 11.7 [0.23]: p < 0.0001} and adults (10.9 g/dl [0.14], 11.9 [0.19]: p < 0.0001); transferrin saturation, ferritin [in adolescents] and hepcidin [in adults] also increased significantly. On per-protocol univariate analysis, the haemoglobin response was inversely related to baseline haemoglobin, CRP and hepcidin. Oral iron did not alter disease activity; it improved Short IBDQ and Perceived Stress Questionnaire scores in adults.

conclusionOral ferrous sulphate was no less effective or well-tolerated in adolescents than adults, and did not increase disease activity in this short-term study. The inverse relation between baseline CRP and hepcidin levels and the haemoglobin response suggests that CRP or hepcidin measurements could influence decisions on whether iron should be given orally or intravenously. [ClinTrials.gov registration number NCT01991314].

Indexed as

Administration, OralAdolescentAdultAnemia, Iron-DeficiencyFecesFemaleFerritinsFerrous CompoundsHemoglobinsHepcidinsHumansInflammatory Bowel DiseasesIntention to Treat AnalysisLeukocyte L1 Antigen ComplexMaleProspective StudiesFerritinsFerrous Compoundsferrous sulfateHemoglobinsHepcidinsLeukocyte L1 Antigen ComplexTransferrinhepcidininflammatory bowel diseaseiron deficiency anaemia

Identifiers

PMID27932449
PMCPMC5881709
OpenAlexW2560586550

What Socratic holds

Textmetadata
Read underepoch 390

Registered trials

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 Socratic graph.