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OpenTrials
Completed

NCT Number: NCT00919230

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Peterborough city hospital

Peterborough, Cambs, pe67nj, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients with anaemia after surgery for a hip fracture

Exclusion criteria

  • absence of anaemia, inability to provide consent

Treatment and study plan

Ferrous sulphate tablets

Drug

200mg twice daily for four weeks

Primary outcomes

  1. 6 week hemoglobin

    Time frame: 6 weeks after surgery

Secondary outcomes

  1. Length of hospital stay side effects of therapy mortality

    Time frame: one year

Sponsors and collaborators

Lead sponsor

Peterborough and Stamford Hospitals NHS Foundation Trust

Other

Collaborators

  • Peterborough Hospitals Hip Fracture Project

Registry information

Important dates

Study start
2004
Primary completion
2009
Study completion
2009
First posted
Jun 12, 2009
Registry last updated
Dec 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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