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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Hip Fracture
 Drug: Ferrous sulphate tablets
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomised Trial Comparing Iron Supplementation Versus Placebo in the Treatment of Anaemia After Hip Fracture

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Peterborough and Stamford Hospitals NHS Foundation Trust:

Primary Outcome Measures:
  • 6 week hemoglobin [ Time Frame: 6 weeks after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Length of hospital stay side effects of therapy mortality [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 300
Study Start Date: July 2004
Study Completion Date: August 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: no treatment
no iron given
Experimental: ferrous sulphate
iron given
 Drug: Ferrous sulphate tablets
200mg twice daily for four weeks

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with anaemia after surgery for a hip fracture

Exclusion Criteria:

  • absence of anaemia, inability to provide consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00919230

Locations
United Kingdom
Peterborough city hospital
Peterborough, Cambs, United Kingdom, pe67nj
Sponsors and Collaborators
Peterborough and Stamford Hospitals NHS Foundation Trust
Peterborough Hospitals Hip Fracture Project
Investigators
Principal Investigator: Martyn Parker Peterborough Hospitals
  More Information

Publications:

Responsible Party: Martyn J Parker, research fellow, Peterborough and Stamford Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT00919230     History of Changes
Other Study ID Numbers: R&D/2003/21
Study First Received: June 11, 2009
Last Updated: December 7, 2012
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Peterborough and Stamford Hospitals NHS Foundation Trust:
Hip fracture
iron therapy
anaemia

Additional relevant MeSH terms:
Anemia
Fractures, Bone
Hip Fractures
Hematologic Diseases
Wounds and Injuries
Femoral Fractures
Hip Injuries
 Leg Injuries
Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013