Effectiveness of iron supplementation in the non-anaemic iron deficient patient population undergoing arthroplasty

ISIDA: Iron Supplementation for non-anaemic Iron Deficiency before lower limb Arthroplasty

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN48118194

Enrollment

188

Registered

2019-02-04

Start date

2019-04-18

Completion date

Unknown

Last updated

2019-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-anaemic iron deficiency Nutritional, Metabolic, Endocrine Non-anaemic iron deficiency

Interventions

Randomisation will be performed using simple randomisation with the algorithm from www.randomization.com. Patients will be randomised to receive either the intervention or the control.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Undergoing primary knee or hip replacement surgery 2. Aged over 18 years 3. Non-anaemic iron deficiency, diagnosed using the following criteria: 3.1. Haemoglobin levels >12 for women and >13 for men 3.2. Ferritin levels <50 4. Not already be taking regular oral iron 5. Provide informed consent

Exclusion criteria

Exclusion criteria: 1. Lack capacity to consent to inclusion in the trial 2. Refusal to participate 3. Known allergy/intolerance to any iron supplementation treatment option 4. Pregnancy 5. Listed for surgery within four weeks of commencing iron supplementation

Design outcomes

Primary

Measure	Time frame
Haemoglobin recovery, assessed using blood samples taken at the baseline and 3 weeks after surgery	—

Secondary

Measure	Time frame
1. Length of hospital stay, determined using the patient administration system throughout the study 2. Transfusion rate and number of units transfused, assessed using the transfusion database after 30 days 3. Adverse events (including all cause morbidity and mortality, assessed using patient clinical notes after 30 and 90 days 4. Full blood count (FBC), C-reactive protein (CRP) and ferritin levels, assessed using a blood test every 4 weeks throughout the 6 month trial 5. Readmission within 30 days of surgery, assessed using the patient administration system up to 30 days after surgery 6. Inpatient deep vein thrombosis (DVT) or pulmonary embolism (PE) within 30 days of surgery, assessed using patient clinical notes up to 30 days after surgery 7. Pneumonia within 30 days of surgery, assessed using patient clinical notes up to 30 days after surgery 8. Cerebrovascular incident within 30 days of surgery, assessed using patient clinical notes up to 30 days after surgery 9. Myocardial infarction within 30 days?, assessed using patient clinical notes up to 30 days after surgery 10. Fatigue, assessed using the FACIT Fatigue Scale 4 weeks after surgery 11. Quality of life, assessed using the EQ-5D-5L questionnaire 3 months after surgery	—

Measure

Time frame

1. Length of hospital stay, determined using the patient administration system throughout the study 2. Transfusion rate and number of units transfused, assessed using the transfusion database after 30 days 3. Adverse events (including all cause morbidity and mortality, assessed using patient clinical notes after 30 and 90 days 4. Full blood count (FBC), C-reactive protein (CRP) and ferritin levels, assessed using a blood test every 4 weeks throughout the 6 month trial 5. Readmission within 30 days of surgery, assessed using the patient administration system up to 30 days after surgery 6. Inpatient deep vein thrombosis (DVT) or pulmonary embolism (PE) within 30 days of surgery, assessed using patient clinical notes up to 30 days after surgery 7. Pneumonia within 30 days of surgery, assessed using patient clinical notes up to 30 days after surgery 8. Cerebrovascular incident within 30 days of surgery, assessed using patient clinical notes up to 30 days after surgery 9. Myocardial infarction within 30 days?, assessed using patient clinical notes up to 30 days after surgery 10. Fatigue, assessed using the FACIT Fatigue Scale 4 weeks after surgery 11. Quality of life, assessed using the EQ-5D-5L questionnaire 3 months after surgery

—

Countries

United Kingdom

Contacts

Public ContactMike Reed

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026