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

This study has been completed.
Sponsor:
Collaborator:
Peterborough Hospitals Hip Fracture Project
Information provided by (Responsible Party):
Martyn J Parker, Peterborough and Stamford Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00919230
First received: June 11, 2009
Last updated: December 7, 2012
Last verified: December 2012

June 11, 2009
December 7, 2012
July 2004
July 2009   (final data collection date for primary outcome measure)
6 week hemoglobin [ Time Frame: 6 weeks after surgery ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00919230 on ClinicalTrials.gov Archive Site
Length of hospital stay side effects of therapy mortality [ Time Frame: one year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Randomised Trial Comparing Iron Supplementation Versus Placebo in the Treatment of Anaemia After Hip Fracture
Randomised Trial Comparing Iron Supplementation Versus Placebo in the Treatment of Anaemia After Hip Fracture

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Hip Fracture
Drug: Ferrous sulphate tablets
200mg twice daily for four weeks
  • No Intervention: no treatment
    no iron given
  • Experimental: ferrous sulphate
    iron given
    Intervention: Drug: Ferrous sulphate tablets
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
August 2009
July 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • patients with anaemia after surgery for a hip fracture

Exclusion Criteria:

  • absence of anaemia, inability to provide consent
Both
60 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00919230
R&D/2003/21
Yes
Martyn J Parker, Peterborough and Stamford Hospitals NHS Foundation Trust
Peterborough and Stamford Hospitals NHS Foundation Trust
Peterborough Hospitals Hip Fracture Project
Principal Investigator: Martyn Parker Peterborough Hospitals
Peterborough and Stamford Hospitals NHS Foundation Trust
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP