Condition category
Nutritional, Metabolic, Endocrine
Date applied
31/10/2018
Date assigned
04/02/2019
Last edited
04/02/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Anaemia is a condition where the body does not have as much haemoglobin or as many red blood cells as it needs. An international consensus statement suggesting the need to treat preoperative anaemia was published in 2016. In this statement, anaemia and non-anaemic iron deficiency (where the body does not have as much iron as it needs) were identified as patient groups that would benefit from the introduction of pre-operative anaemia screening, assessment and treatment. They suggested that patients with low iron levels, with or without anaemia, should be given iron supplementation to enable them to recover from surgery. The benefits of this has been demonstrated in the anaemic population, whereas there is limited research into this for the non-anaemic iron deficient population.
The aim of this trial is to analyse the effect of iron supplementation in non-anaemic iron deficient patients undergoing lower limb arthroplasty.

Who can participate?
Adult non-anaemic iron deficient patients undergoing hip or knee arthroplasty

What does the study involve?
Participants will be randomly allocated to the intervention group or the control group. The intervention group will receive iron supplementation for six months, covering the pre-operative and post-operative phases of their care. They will receive supplementation for 4 weeks prior to their surgery. The control group will receive care as usual. All participants will have blood tests every 4 weeks throughout the trial, along with 3 weeks after surgery. They will also be asked to complete questionnaires 4 weeks after surgery and 3 months after surgery.

What are the possible benefits and risks of participating?
The possible benefit to participants in the intervention group is that iron supplementation may be effective in improving their recovery from surgery. There are no known benefits for the control group. The results of this study may benefit future patients if the treatment is proven to be effective.
Possible risks of participating include the standard risks associated with blood samples and gastrointestinal symptoms of oral iron supplementation. These symptoms include abdominal pain, constipation, diarrhoea, nausea and dark stools.

Where is the study run from?
Northumbria Healthcare NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
May 2018 to May 2020

Who is funding the study?
SALUS Haus (Germany)

Who is the main contact?
Mike Reed
mike.reed@nhs.net

Trial website

Contact information

Type

Public

Primary contact

Prof Mike Reed

ORCID ID

http://orcid.org/0000-0002-6309-2710

Contact details

Northumbria Healthcare NHS Trust
Wansbeck General Hospital
Woodhorn Lane
Northumberland
NE63 9JJ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ISIDA Protocol 1.0

Study information

Scientific title

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

Acronym

ISIDA

Study hypothesis

Non-anaemic iron deficient patients undergoing lower limb arthroplasty will benefit from iron supplementation to improve their haemoglobin recovery post surgery, whilst improving anaemia symptoms.

Ethics approval

HRA and Health and Care Research Wales (HCRW), 21/12/2018, ref: 18/NE/0371

Study design

Interventional single centre two-armed randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Non-anaemic iron deficiency

Intervention

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.
The intervention arm will receive oral iron supplementation with Foradix mit Eisen (36.8 mg oral iron daily) for 6 months from the point of inclusion, which includes the preoperative and postoperative phases of care.
The control arm will receive no intervention and will have care as usual.
All patients will have blood sampling at 3 weeks post surgery, and at 4 weekly intervals during the trial to test for haemoglobin, C-reactive protein and ferritin levels.
From enrollment in the trial, participants will have blood samples taken every 4 weeks up to 6 months, and will be asked to complete questionnaires 4 weeks after surgery and 3 months after surgery.

Intervention type

Supplement

Phase

Drug names

Primary outcome measure

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

Secondary outcome measures

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

Overall trial start date

01/05/2018

Overall trial end date

31/05/2020

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

188 research participants, 94 in each trial arm

Participant 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

Recruitment start date

18/04/2019

Recruitment end date

30/11/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Northumbria Healthcare NHS Foundation Trust
Research and Development North Tyneside General Hospital Rake Lane North Shields
Northumberland
NE29 8NH
United Kingdom

Sponsor information

Organisation

Northumbria Healthcare NHS Foundation Trust

Sponsor details

Research and Development Department
North Tyneside General Hospital
Rake lane
North Shields
NE29 8NH
United Kingdom

Sponsor type

Hospital/treatment centre

Website

www.northumbria.nhs.uk

Funders

Funder type

Industry

Funder name

SALUS Haus (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Publication will be sought in an international journal on the primary and secondary outcome data and in a PhD Thesis. Outcomes will be shared at scientific meetings

IPD sharing statement:
Anonymised raw data from the primary and secondary outcomes will become available after publication. This may be shared with researchers for future research purposes and access will be assessed on an individual basis. Patients have provided consent for anonymised data sharing for the purpose of future research.

Intention to publish date

01/03/2021

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

04/02/2019: The recruitment start date was changed from 01/02/2019 to 18/04/2019.