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Completed

NCT Number: NCT02300428

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

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

MRC Human Nutrition Research

Cambridge, Cambridgeshire, CB1 9NL, United Kingdom

About this study

Our research objective is to gather evidence for the unmet clinical need for safe, low-side-effect oral iron in the UK.

To achieve this objective we aim to determine:

  • Pattern of prescribing to oral iron in primary care in GP practices in England: estimate prescription rates, efficacy and intolerance of treatment with all forms of currently prescribed oral iron.
  • Health economics of the use of ferrous iron salts in primary care: estimate patterns of individual response to treatment; determine the costs of ferrous iron (sulphate, fumarate and gluconate) therapy in pre-menopausal women in primary care, and develop a cost-effectiveness model for alternative treatments with minimal side-effects.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients prescribed oral iron in primary care practices included in the UK CPRD database

Exclusion criteria

  • N/A

Treatment and study plan

Oral iron

Dietary Supplement

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

Other names: Dried ferrous sulphate tablets 200mg, Ferrous fumarate tablets 210mg, Ferrous gluconate tablets 300mg, Ferrous fumarate tablets 322mg (incl. Fersaday), Ferrous fumarate capsules 305mg (incl. Galfer), Dried ferrous sulphate MR tab 325mg (incl. Ferrograd)

Primary outcomes

  1. Prescription rate

    Time frame: 12 months

    number of prescriptions of iron supplements issued at the patient level in the year

  2. Health Economics Modelling

    Time frame: 10 years

    In this analysis we will determine the following to parameterise the model that will be based on the cohort study over a 10 years period:

    i) Frequency of repeat oral iron prescriptions, ii) Number of hospital admissions, i) Incidence of gastrointestinal side-effects, ii) Treatment cessation rate iii) Haemoglobin changes

    The basis for the model will be the above data extracted from the CPRD, further informed by publicly available clinical trial data.

Secondary outcomes

  1. Efficacy

    Time frame: 12 months

    increase in Hb of at least 2 g/dL or to >12 g/dL

  2. Gastrointestinal intolerance

    Time frame: 12 months

    At least one event of i. change in product; ii. reduction in dose; iii cessation of treatment with no improvement in Hb during the 12 months

Sponsors and collaborators

Lead sponsor

dora pereira

Other Gov

Collaborators

  • Bangor University
  • University of Cambridge
  • University of Oxford

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Nov 25, 2014
Registry last updated
Mar 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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