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Randomised Trial Comparing Iron Supplementation Versus Placebo in the Treatment of Anaemia After Hip Fracture

NCT ID: NCT00919230

Last Updated: 2012-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2009-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hip Fracture

Keywords

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Hip fracture iron therapy anaemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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no treatment

no iron given

Group Type NO_INTERVENTION

No interventions assigned to this group

ferrous sulphate

iron given

Group Type EXPERIMENTAL

Ferrous sulphate tablets

Intervention Type DRUG

200mg twice daily for four weeks

Interventions

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Ferrous sulphate tablets

200mg twice daily for four weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* patients with anaemia after surgery for a hip fracture

Exclusion Criteria

* absence of anaemia, inability to provide consent
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peterborough Hospitals Hip Fracture Project

UNKNOWN

Sponsor Role collaborator

Peterborough and Stamford Hospitals NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Martyn J Parker

research fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Martyn Parker

Role: PRINCIPAL_INVESTIGATOR

Peterborough Hospitals

Locations

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Peterborough city hospital

Peterborough, Cambs, United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type BACKGROUND
PMID: 20124051 (View on PubMed)

Other Identifiers

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R&D/2003/21

Identifier Type: -

Identifier Source: org_study_id