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

Peterborough and Stamford Hospitals NHS Foundation Trust

Status and phase: Completed; Phase 3

Conditions: Hip Fracture

Treatments: Drug: Ferrous sulphate tablets

Study type: Interventional

Funder types: Other

Identifiers

NCT00919230

R&D/2003/21

Details and patient eligibility

About

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.

Enrollment: 300 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with anaemia after surgery for a hip fracture

Exclusion criteria

• absence of anaemia, inability to provide consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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300 participants in 2 patient groups

no treatment

No Intervention group

Description:

no iron given

ferrous sulphate

Experimental group

Description:

iron given

Treatment:

Drug: Ferrous sulphate tablets