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

Primary Purpose

Hip Fracture

Status
Completed
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
Ferrous sulphate tablets
Sponsored by
Peterborough and Stamford Hospitals NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Fracture focused on measuring Hip fracture, iron therapy, anaemia

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients with anaemia after surgery for a hip fracture

Exclusion Criteria:

  • absence of anaemia, inability to provide consent

Sites / Locations

  • Peterborough city hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

no treatment

ferrous sulphate

Arm Description

no iron given

iron given

Outcomes

Primary Outcome Measures

6 week hemoglobin

Secondary Outcome Measures

Length of hospital stay side effects of therapy mortality

Full Information

First Posted
June 11, 2009
Last Updated
December 7, 2012
Sponsor
Peterborough and Stamford Hospitals NHS Foundation Trust
Collaborators
Peterborough Hospitals Hip Fracture Project
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1. Study Identification

Unique Protocol Identification Number
NCT00919230
Brief Title
Randomised Trial Comparing Iron Supplementation Versus Placebo in the Treatment of Anaemia After Hip Fracture
Official Title
Randomised Trial Comparing Iron Supplementation Versus Placebo in the Treatment of Anaemia After Hip Fracture
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peterborough and Stamford Hospitals NHS Foundation Trust
Collaborators
Peterborough Hospitals Hip Fracture Project

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fracture
Keywords
Hip fracture, iron therapy, anaemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
no treatment
Arm Type
No Intervention
Arm Description
no iron given
Arm Title
ferrous sulphate
Arm Type
Experimental
Arm Description
iron given
Intervention Type
Drug
Intervention Name(s)
Ferrous sulphate tablets
Intervention Description
200mg twice daily for four weeks
Primary Outcome Measure Information:
Title
6 week hemoglobin
Time Frame
6 weeks after surgery
Secondary Outcome Measure Information:
Title
Length of hospital stay side effects of therapy mortality
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients with anaemia after surgery for a hip fracture Exclusion Criteria: absence of anaemia, inability to provide consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martyn Parker
Organizational Affiliation
Peterborough Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peterborough city hospital
City
Peterborough
State/Province
Cambs
ZIP/Postal Code
pe67nj
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
20124051
Citation
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.
Results Reference
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Randomised Trial Comparing Iron Supplementation Versus Placebo in the Treatment of Anaemia After Hip Fracture

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