Randomised Trial Comparing Iron Supplementation Versus Placebo in the Treatment of Anaemia After Hip Fracture
1 other identifier
interventional
300
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2004
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2004
CompletedFirst Submitted
Initial submission to the registry
June 11, 2009
CompletedFirst Posted
Study publicly available on registry
June 12, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedDecember 10, 2012
December 1, 2012
5 years
June 11, 2009
December 7, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
6 week hemoglobin
6 weeks after surgery
Secondary Outcomes (1)
Length of hospital stay side effects of therapy mortality
one year
Study Arms (2)
no treatment
NO INTERVENTIONno iron given
ferrous sulphate
EXPERIMENTALiron given
Interventions
Eligibility Criteria
You may qualify if:
- patients with anaemia after surgery for a hip fracture
You may not qualify if:
- absence of anaemia, inability to provide consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peterborough city hospital
Peterborough, Cambs, pe67nj, United Kingdom
Related Publications (1)
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.
PMID: 20124051BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Martyn Parker
Peterborough Hospitals
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- research fellow
Study Record Dates
First Submitted
June 11, 2009
First Posted
June 12, 2009
Study Start
July 1, 2004
Primary Completion
July 1, 2009
Study Completion
August 1, 2009
Last Updated
December 10, 2012
Record last verified: 2012-12