Hip FracturePhase 3NCT00919230
Randomised Trial Comparing Iron Supplementation Versus Placebo in the Treatment of Anaemia After Hip Fracture
A Phase 3 study testing Ferrous sulphate tablets in people with Hip Fracture, run by Peterborough and Stamford Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
At present our current practice is to provide a course of oral iron therapy for those patients with a post-operative haemoglobin which is below normal, but not severe enough to require a blood transfusion. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Hip Fracture
- What is being tested?
- Ferrous sulphate tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2004to Aug 2009
- Phase
- Phase 3
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with anaemia after surgery for a hip fracture
Who cannot join
- absence of anaemia, inability to provide consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Peterborough city hospital
Peterborough, Cambs, pe67nj
About this study
At present our current practice is to provide a course of oral iron therapy for those patients with a post-operative haemoglobin which is below normal, but not severe enough to require a blood transfusion. Such a practice is not without side effects from the iron tablets, namely ingestion, nausea, diarrhoea, constipation. There is little evidence in the literature to support the current practice of using iron, with only one small randomised trial suggesting such therapy is unnecessary. We propose to recruit 300 patients recovering from a hip fracture with a post-operative haemoglobin below 11g/l. For those patients willing to enter the study, half will be given oral iron therapy (ferrous sulphate 200mg twice daily) for one month. The haemoglobin will be checked when the patients attends the hip fracture clinic at 6 weeks after discharge.
- Conditions
- Hip Fracture
- Being tested
- Ferrous sulphate tablets
- Keywords
- Hip fracture, iron therapy, anaemia
- Medical subject headings
- Hip Fractures, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferrous sulphate tabletsDrug
200mg twice daily for four weeks
| Study group | Role | What they receive |
|---|---|---|
| no treatment | No intervention | no iron given |
| ferrous sulphate | Experimental | iron given Receives: Drug: Ferrous sulphate tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 week hemoglobin
Measured: 6 weeks after surgery
Secondary outcomes (1)
Length of hospital stay side effects of therapy mortality
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2009 (estimated)
- Study startJul 2004
- Primary completionJul 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hip FractureStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peterborough and Stamford Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Peterborough Hospitals Hip Fracture Project
- Responsible party
- Principal investigator, Martyn J Parker, Peterborough and Stamford Hospitals NHS Foundation Trust
- Investigators
- Martyn Parker, Principal investigator, Peterborough Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00919230
- Sponsor's protocol ID
- R&D/2003/21
- Status last verified
- Dec 2012
- First submitted
- 11 Jun 2009
- Last updated
- 10 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Parker MJ. Iron supplementation for anemia after hip fracture surgery: a randomized trial of 300 patients. J Bone Joint Surg Am. 2010 Feb;92(2):265-9. doi: 10.2106/JBJS.I.00883.
PubMed 20124051
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Trial Comparing Iron Supplementation Versus Placebo in the Treatment of Anaemia After Hip Fracture
- ClinicalTrials.gov ID
- NCT00919230
- Acronym / sponsor ID
- R&D/2003/21
- Conditions
- Hip Fracture
- Keywords
- Hip fracture, iron therapy, anaemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Peterborough and Stamford Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Peterborough Hospitals Hip Fracture Project
- Study start
- Jul 2004
- Primary completion
- Jul 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 12 Jun 2009 (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.
At present our current practice is to provide a course of oral iron therapy for those patients with a post-operative haemoglobin which is below normal, but not severe enough to require a blood transfusion. Such a practice is not without side effects from the iron tablets, namely ingestion, nausea, diarrhoea, constipation. There is little evidence in the literature to support the current practice of using iron, with only one small randomised trial suggesting such therapy is unnecessary. We propose to recruit 300 patients recovering from a hip fracture with a post-operative haemoglobin below 11g/l. For those patients willing to enter the study, half will be given oral iron therapy (ferrous sulphate 200mg twice daily) for one month. The haemoglobin will be checked when the patients attends the hip fracture clinic at 6 weeks after discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| no treatment | No intervention | –no iron given |
| ferrous sulphate | Experimental | Drug: Ferrous sulphate tabletsiron given |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with anaemia after surgery for a hip fracture
Key exclusion criteria (1 listed)
- absence of anaemia, inability to provide consent
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 |
|---|---|---|
| Ferrous sulphate tablets200mg twice daily for four weeks | Drug | ferrous sulphate |
Primary outcome
6 week hemoglobin
Time frame: 6 weeks after surgery
1 secondary outcome
Length of hospital stay side effects of therapy mortality
Time frame: one year
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 10 Dec 2012.
- Background: PubMed 20124051Parker MJ. Iron supplementation for anemia after hip fracture surgery: a randomized trial of 300 patients. J Bone Joint Surg Am. 2010 Feb;92(2):265-9. doi: 10.2106/JBJS.I.00883.
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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.
Martyn Parker principal investigator
Peterborough Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ferrous sulphate tablets in people with Hip Fracture, run by Peterborough and Stamford Hospitals NHS Foundation Trust 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 10 Dec 2012. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
6 week hemoglobin (time frame: 6 weeks after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00919230, which also lists 1 linked publication.
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 10 Dec 2012.