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

Hip Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00919230
• Other study ID #: R&D/2003/21
• Status: Completed
• Phase: Phase 3
• First received: June 11, 2009
• Last updated: December 7, 2012
• Start date: July 2004
• Est. completion date: August 2009

Study information

• Verified date: December 2012
• Source: Peterborough and Stamford Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: August 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• patients with anaemia after surgery for a hip fracture

Exclusion Criteria:

• absence of anaemia, inability to provide consent

Related Conditions & MeSH terms

• Anemia
• Fractures, Bone
• Hip Fracture
• Hip Fractures

Intervention

Drug:
• Ferrous sulphate tablets
200mg twice daily for four weeks

Locations

Country	Name	City	State
United Kingdom	Peterborough city hospital	Peterborough	Cambs

Sponsors (2)

Lead Sponsor	Collaborator
Peterborough and Stamford Hospitals NHS Foundation Trust	Peterborough Hospitals Hip Fracture Project

Country where clinical trial is conducted

United Kingdom, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6 week hemoglobin		6 weeks after surgery
Secondary	Length of hospital stay side effects of therapy mortality		one year