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

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ClinicalTrials.gov Identifier: NCT00919230
Recruitment Status : Completed
First Posted : June 12, 2009
Last Update Posted : December 10, 2012
Sponsor:
Collaborator:
Peterborough Hospitals Hip Fracture Project
Information provided by (Responsible Party):
Martyn J Parker, Peterborough and Stamford Hospitals NHS Foundation Trust

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.

Condition or disease Intervention/treatment Phase
Hip Fracture Drug: Ferrous sulphate tablets Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomised Trial Comparing Iron Supplementation Versus Placebo in the Treatment of Anaemia After Hip Fracture
Study Start Date : July 2004
Actual Primary Completion Date : July 2009
Actual Study Completion Date : August 2009


Arm Intervention/treatment
No Intervention: no treatment
no iron given
Experimental: ferrous sulphate
iron given
Drug: Ferrous sulphate tablets
200mg twice daily for four weeks



Primary Outcome Measures :
  1. 6 week hemoglobin [ Time Frame: 6 weeks after surgery ]

Secondary Outcome Measures :
  1. Length of hospital stay side effects of therapy mortality [ Time Frame: one year ]


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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: June 12, 2009    Key Record Dates
Last Update Posted: December 10, 2012
Last Verified: December 2012

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

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