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

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ClinicalTrials.gov Identifier: NCT02300428
Recruitment Status : Completed
First Posted : November 25, 2014
Last Update Posted : March 21, 2018
Sponsor:
Collaborators:
University of Cambridge
Bangor University
University of Oxford
Information provided by (Responsible Party):
dora pereira, Medical Research Council

Brief 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.


Condition or disease Intervention/treatment
Anemia Dietary Supplement: oral iron

Detailed Description:

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:

  1. 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.
  2. 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.

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Study Type : Observational
Actual Enrollment : 406902 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Health Economics of the Use of Ferrous Iron Salts in Primary Care in the UK.
Study Start Date : November 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron Sodium

Group/Cohort Intervention/treatment
1-year cohort

Patients with at least 1 prescription of any oral iron preparation in the last 2 years and who have at least 1 year of follow up data post-prescription.

It is anticipated that ca. 123,000 patients in CPRD fulfil this criteria.

Dietary Supplement: oral iron
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)

10-year cohort

All pre-menopausal women (18-45 years old) with at least 1 prescription of one ferrous iron salt (i.e. sulphate, fumarate and gluconate) since January 2000.

It is anticipated that ca. 299,000 patients in CPRD fulfil this criteria.

Dietary Supplement: oral iron
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 Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

For the 1-year cohort study we are not defining a sub-population group and will investigate all individuals (adults and children) prescribed any type of oral iron at least once in the time period assessed, although a breakdown by key sociodemographic (age, gender, ethnicity) will be conducted.

For the 10-year plus cohort study, pre-menopausal women in receipt of ferrous iron supplements are our study population of interest.

Pre-menopausal women are the population group with the largest number of individuals affected (nearly 2M) by IDA in the UK, mainly because dietary iron intake does not sufficiently offset menorrhagic iron losses.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • N/A

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02300428


Locations
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United Kingdom
MRC Human Nutrition Research
Cambridge, Cambridgeshire, United Kingdom, CB1 9NL
Sponsors and Collaborators
dora pereira
University of Cambridge
Bangor University
University of Oxford
Investigators
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Principal Investigator: Dora Pereira, PhD MRC Human Nutrition Research

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Responsible Party: dora pereira, Senior Investigator Scientist, Medical Research Council
ClinicalTrials.gov Identifier: NCT02300428     History of Changes
Other Study ID Numbers: 6531
First Posted: November 25, 2014    Key Record Dates
Last Update Posted: March 21, 2018
Last Verified: March 2018

Keywords provided by dora pereira, Medical Research Council:
iron deficiency

Additional relevant MeSH terms:
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Iron
Ferrous fumarate
Ferrous gluconate
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Hematinics