Health Economics of the Use of Ferrous Iron Salts in Primary Care in the UK.

NCT02300428 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 406902

Last updated 2018-03-21

No results posted yet for this study

Summary

Iron deficiency anaemia (IDA) affects approximately 4.7 million of people in the UK, with children and pre-menopausal women being at higher risk (1). Each year more than 6.8 million prescriptions for oral iron are filled in England alone (NHS Information Centre data). However, gastrointestinal symptoms limit adherence in 10-30% of otherwise healthy patients (2-4) and in up to 50% of patients with gastrointestinal disorders (5). Simple ferrous iron salts constitute the vast majority of currently prescribed oral iron because these are cheap and well absorbed. However, they are also poorly tolerated and thus, we believe, are expensive to the NHS.

Funded by the Medical Research Council, we have developed an alternative oral iron supplement, that we name IHAT (iron hydroxide adipate tartrate), as an efficacious therapy for IDA with minimal side-effects.

In the study proposed here we aim to assess the total health cost associated with current oral iron supplements and, hence, define the clinical unmet need for alternative treatments. We will use Clinical Practice Research Datalink (CPRD) GOLD data to (i) estimate the pattern of prescribing to oral iron in primary care in the general population and (ii) develop a health economics model in pre-menopausal women. These data will provide evidence for the total health system costs associated with current oral iron treatment. Furthermore, this study will provide data from which the cost-effectiveness and total health system costs of alternative effective and treatments with minimal side-effects could be estimated.

Conditions

Interventions

DIETARY_SUPPLEMENT

oral iron

BNF code for section 9.1.1.1 (Oral iron preparations for iron-deficiency anaemias)

Sponsors & Collaborators

  • University of Cambridge

    collaborator OTHER
  • Bangor University

    collaborator OTHER
  • University of Oxford

    collaborator OTHER
  • dora pereira

    lead OTHER_GOV

Principal Investigators

  • Dora Pereira, PhD · MRC Human Nutrition Research

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2016-04-30
Completion
2017-12-31

Countries

  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02300428 on ClinicalTrials.gov