AnemiaNCT02300428
Health Economics of the Use of Ferrous Iron Salts in Primary Care in the UK.
An observational study of Anemia, run by dora pereira at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anemia
- What is being tested?
- oral iron
- Type of treatment
- Pill or oral medicine
- How many people
- 406,902 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2014to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- patients prescribed oral iron in primary care practices included in the UK CPRD database
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
MRC Human Nutrition Research
Cambridge, Cambridgeshire, CB1 9NL
About this study
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.
Read the 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:
- 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.
- Conditions
- Anemia
- Being tested
- oral iron
- Keywords
- iron deficiency
- Medical subject headings
- Anemia, Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral ironDietary supplement
Also called Dried ferrous sulphate tablets 200mg, Ferrous fumarate tablets 210mg, Ferrous gluconate tablets 300mg, Ferrous fumarate tablets 322mg (incl. Fersaday)
BNF code for section 9.1.1.1 (Oral iron preparations for iron-deficiency anaemias)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: oral iron | |
| 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. Receives: Dietary Supplement: oral iron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prescription rate
number of prescriptions of iron supplements issued at the patient level in the year
Measured: 12 months
Health Economics Modelling
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:
- 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.
Measured: 10 years
Secondary outcomes (2)
Efficacy
increase in Hb of at least 2 g/dL or to >12 g/dL
Measured: 12 months
Gastrointestinal intolerance
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionApr 2016
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 406,902 participants (actual)
Sponsor and investigators
- Lead sponsor
- dora pereira
- Sponsor type
- Other government
- Collaborators
- University of Cambridge, Bangor University, University of Oxford
- Responsible party
- Sponsor-investigator, dora pereira, Medical Research Council
- Investigators
- Dora Pereira, PhD, Principal investigator, MRC Human Nutrition Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02300428
- Sponsor's protocol ID
- 6531
- Status last verified
- Mar 2018
- First submitted
- 24 Nov 2014
- Last updated
- 21 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Economics of the Use of Ferrous Iron Salts in Primary Care in the UK.
- ClinicalTrials.gov ID
- NCT02300428
- Acronym / sponsor ID
- 6531
- Conditions
- Anemia
- Keywords
- iron deficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 406,902 participants (actual)
- Lead sponsor
- dora pereiraOther government
- Collaborators
- University of Cambridge, Bangor University, University of Oxford
- Study start
- Nov 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 25 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1-year cohort | – | Dietary Supplement: oral ironPatients 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. |
| 10-year cohort | – | Dietary Supplement: oral ironAll 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- patients prescribed oral iron in primary care practices included in the UK CPRD database
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral ironAlso: Dried ferrous sulphate tablets 200mg, Ferrous fumarate tablets 210mg, Ferrous gluconate tablets 300mg, Ferrous fumarate tablets 322mg (incl. Fersaday)BNF code for section 9.1.1.1 (Oral iron preparations for iron-deficiency anaemias) | Dietary supplement | 1-year cohort, 10-year cohort |
Primary outcome
Prescription rate
Time frame: 12 months
number of prescriptions of iron supplements issued at the patient level in the year
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.
2 secondary outcomes
Efficacy
Time frame: 12 months
Gastrointestinal intolerance
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dora Pereira, PhD principal investigator
MRC Human Nutrition Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anemia, run by dora pereira at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prescription rate (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2018.