- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00919230
Randomised Trial Comparing Iron Supplementation Versus Placebo in the Treatment of Anaemia After Hip Fracture
December 7, 2012 updated by: Martyn J Parker, Peterborough and Stamford Hospitals NHS Foundation Trust
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 Overview
Study Type
Interventional
Enrollment (Actual)
300
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Cambs
-
Peterborough, Cambs, United Kingdom, pe67nj
- Peterborough City Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- patients with anaemia after surgery for a hip fracture
Exclusion Criteria:
- absence of anaemia, inability to provide consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: no treatment
no iron given
|
|
Experimental: ferrous sulphate
iron given
|
200mg twice daily for four weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
6 week hemoglobin
Time Frame: 6 weeks after surgery
|
6 weeks after surgery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Length of hospital stay side effects of therapy mortality
Time Frame: one year
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Martyn Parker, Peterborough Hospitals
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2004
Primary Completion (Actual)
July 1, 2009
Study Completion (Actual)
August 1, 2009
Study Registration Dates
First Submitted
June 11, 2009
First Submitted That Met QC Criteria
June 11, 2009
First Posted (Estimate)
June 12, 2009
Study Record Updates
Last Update Posted (Estimate)
December 10, 2012
Last Update Submitted That Met QC Criteria
December 7, 2012
Last Verified
December 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R&D/2003/21
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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