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CompletedNCT00919230Updated Dec 10, 2012

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

A Phase 3 interventional study of Ferrous sulphate tablets in Hip Fracture, sponsored by Peterborough and Stamford Hospitals NHS Foundation Trust. Completed at 1 site in United Kingdom. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2012-12-10.

Sponsored by Peterborough and Stamford Hospitals NHS Foundation Trust · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
60 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Hip Fracture

Keywords

  • Hip fracture
  • iron therapy
  • anaemia
03

In context

Anemia

1,733 studies on the registry are indexed under Anemia; 246 are open to participants now.

This study's enrollment of 300 is above the median of 94 across 1,291 interventional studies indexed under Anemia.

Browse Anemia studies →

Lead sponsor

Peterborough and Stamford Hospitals NHS Foundation Trust is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • patients with anaemia after surgery for a hip fracture

Exclusion criteria

Exclusion Criteria:

  • absence of anaemia, inability to provide consent
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Single (Outcomes assessor)
Enrollment
300 participants (actual)

Study arms

  • No intervention
    no treatment

    no iron given

  • Experimental
    ferrous sulphate

    iron given

    Drug: Ferrous sulphate tablets

Interventions

  • DrugFerrous sulphate tablets

    200mg twice daily for four weeks

06

What researchers measure

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

07

Study locations

1 site
  • Peterborough city hospital
    Peterborough, Cambs pe67nj, United Kingdom
08

References and documents

Publications

  • 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. PubMed 20124051 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 10, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00919230
Lead sponsor
Peterborough and Stamford Hospitals NHS Foundation Trust
Collaborators
Peterborough Hospitals Hip Fracture Project
Responsible party
Martyn J Parker (research fellow, Peterborough and Stamford Hospitals NHS Foundation Trust) — Principal investigator
First posted
Jun 12, 2009
Start date
Jul 2004
Primary completion
Jul 2009
Completion
Aug 2009
Last update
Dec 10, 2012

Study contacts

Martyn Parker
principal investigator · Peterborough Hospitals

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.

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