Condition category
Haematological Disorders
Date applied
14/09/2016
Date assigned
23/09/2016
Last edited
05/10/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Iron deficiency anaemia is a health condition where a lack of iron in the body results in a fewer than normal number of red blood cells. Red blood cells help to store and carry oxygen in the blood and if there are fewer than usual then the body may not get as much oxygen as it should. Symptoms of iron deficiency anaemia include feeling very tired, breathlessness, heart palpitations and looking palter than usual. This study looks at the effects of low iron (i.e. iron deficiency anaemia and iron deficiency non-anaemia) and its impact on the performance of women who exercise. Endurance exercise can cause small iron loss through haematuria (blood in urine), gastrointestinal bleeding, sweating and haemolysis (destruction of red blood cells, particularly so for impact sports involving foot strike). Females who participate regularly in endurance training therefore are more likely to have an iron deficiency, particularly so for women on their period (menstruating). Iron is essential for the healthy functioning of the body and deficiency will eventually result in a reduction in energy levels, weakness, impaired cognition (not being able to think so clearly) and motivation amongst other long-term detrimental effects to the human body. The purpose of this study is therefore to see whether intravenous iron supplementation (iron provided though a drip) improves exercise performance and quality of life in iron deficient exercising women.

Who can participate?
Women (aged at least 18) with lower than usual iron levels and exercise at least 90 minutes a week.

What does the study involve?
All participants are asked to have a screening test to begin with. This involves having a blood test to check their iron status to see if they are eligible for this research. During the visit to the lab each participant is given an overview of the study and will be able to ask questions. This takes place at St Mary’s University, Twickenham. Once they have been accepted onto the study, the participants do an exercise test called the VO2max test (it measures the maximum amount of oxygen that a person can take in and use while exercising), a blood test, a total haemoglobin mass test (another test that measures fitness that requires the participant to breathe in a tiny amount of carbon monoxide) , provide a urine sample and answer 5 questionnaires. . This takes place at St Mary’s University, Twickenham. The participants then go to the iron therapy clinic located at 112 Harley Street, London to receive an iron injection. This will take 15 minutes and each participant will be monitored for 30 minutes afterwards. Two weeks later, the participants are asked to return to St Mary’s University, Twickenham and repeat the tests that were performed at the start (the VO2max test, blood test, total haemoglobin mass test, urine sample and 5 questionnaires. After a further 12 weeks, the participants return to St Mary’s again for a blood test and to complete a last set of questionnaires.

What are the possible benefits and risks of participating?
The most common reported side effects of intravenous iron are dizziness, high blood pressure and/or
injection site reactions. Other less common side effects include an allergic reaction, sensation of pain, a change in taste sensation, high heart rate, low blood pressure, redness in the face, difficulty breathing, vomiting, upset stomach, flatulence, abdominal pain, constipation, diarrhoea, itching, hives, redness of the skin, rash, muscle, joint and/or back pain, muscle spasm, fever , tiredness, chest pain, swelling of the hands and/or the feet, pain and/or chills.

Where is the study run from?
St Mary's University, Twickenham and 112 Harley Street, London

When is the study starting and how long is it expected to run for?
September 2015 to August 2018

Who is funding the study?
SCA-Libresse-Bodyform

Who is the main contact?
Miss Georgie Bruinvels

Trial website

Contact information

Type

Public

Primary contact

Miss Georgie Bruinvels

ORCID ID

http://orcid.org/0000-0002-9352-7228

Contact details

Division of Surgery and Interventional Science
University College London
21 University Street
London
WC1E 6AU
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

15/LO/1570

Study information

Scientific title

The role and effect of intravenous iron isomaltoside at improving functional performance outcome measures and quality of life in iron deficient exercising females

Acronym

IRONWOMAN

Study hypothesis

1. Administration of intravenous iron to iron deficient exercising females will not improve markers of functional performance (including VO2max)
2. Administration of intravenous iron to iron deficient exercising females will not improve quality of life or fatigue
3. No alterations in haemoglobin levels or total haemoglobin mass will be seen when intravenous iron is given to iron deficient exercising females
4. There is no relationship between repletion of iron stores and change in mood state in iron deficient exercising females

Ethics approval

London-Westminster Research Ethics Committee, 16/11/2015, ref: 15/LO/1570

Study design

Observational, pre-post case series study

Primary study design

Observational

Secondary study design

Case series

Trial setting

Other

Trial type

Treatment

Patient information sheet

See additional files

Condition

Iron deficiency

Intervention

Participants identified as likely to meet the study predefined criteria for being iron
deficient are invited to undergo some tests and answer some questionnaires before being given a single injection of iron.

The initial tests and completion of questionnaires will then be repeated on one or two occasions. The aim of giving participants the iron is to return their iron levels to a ‘clinically normal’ level. They are asked to visit St Mary’s University, Twickenham on four occasions for a number of tests, and 112 Harley Street, London as explained below:

1. Screening test – this will involve having a blood test to check iron status to check eligibility. Participants are also given a overview of study and opportunity to ask questions. This will take place at St Mary’s University, Twickenham.
2. Baseline testing – participants undergo a VO2max test, blood test, a total haemoglobin mass test, are asked to provide a urine sample and answer 5 questionnaires (approx. 2 hours for all tests). This
will take place at St Mary’s University, Twickenham.
3. Iron injection - This will be given by a trained medical professional at 12 Harley Street, London. Iron will be infused over a minimum period of 15 minutes. Participants will be given 20 mg/kg of body weight of intravenous iron (iron isomaltoside 1000, Pharmacosmos, UK). All participants will be observed for
for 30 minutes after this. (approx. an hour in total)
4. Follow up testing – 2 weeks after the iron injection, participants are asked to visit St Mary’s University, Twickenham and repeat the tests that were performed at baseline. 3 months (12 weeks) after the iron injection participants are asked back for a final visit to St Mary’s for a blood test and complete the same 5 questionnaires as before.

Intervention type

Drug

Phase

Phase I

Drug names

Iron isomaltoside 1000, Pharmacosmos, UK

Primary outcome measures

Change in VO2max (maximum volume of oxygen) at 2 weeks (+/- 1 week) post-intervention

The VO2max test will consist of two parts, as described below.
1. A discontinuous incremental treadmill test with 3-minute stages at each speed, increasing by 1km.h-1 until lactate increases to around 4mMol.L-1. After each stage, participants will stop for 30s while an earlobe capillary blood sample will be taken for blood lactate analysis using an automated analyser (Biosen C-Line, EFK Diagnostic, Barleben, Germany)
2. Following a 10 minute period of active recovery, participants will complete an incremental maximal test which involves gradient increases of 1% each minute at a constant speed (1-2 km/h slower than reached in part 1). Participants will be encouraged to continue running until they feel they cannot keep going. A capillary blood sample will be collected at the end

Secondary outcome measures

From baseline to 2 weeks (+/- 1 week) post-intervention

1. Change in exercise economy, lactate threshold, lactate turnpoint, time to exhaustion, rate of perceived exertion and vVo2max (velocity at maximal oxygen uptake), measured using an online breath-by-breath analyser
2. Change in haemoglobin levels (blood test)
3. Change in markers of iron status (blood test)
4. Change in FBC parameters (blood test)
5. Change in health-related quality of life or HRQoL, assessed using questionnaires EQ-5D-5L and SQOM
6. Change in thbmass and blood volume (tHbmass test)
7. Change in urinary fractional excretion of phosphate (urine samples)
8. Change in mood (BRUMS Mood Questionnaire)

Overall trial start date

01/09/2015

Overall trial end date

31/08/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Female
2. At least 18 years of age with signed written informed consent
3. Screening haemoglobin [Hb] ≥ 90 g/L (9.0 g/dL) but ≤ 130 g/L (13.0 g/dL)
4. Screening ferritin > 30ng/ml
5. Laboratory data used for determination of eligibility at the baseline visit must not be older than four weeks
6. Undertake at least 90 minutes of regular exercise a week

Participant type

Other

Age group

Adult

Gender

Female

Target number of participants

35

Participant exclusion criteria

Participants who, at the start of treatment, meet any of the following criteria are not eligible for the study:
1. Known history of acquired iron overload, or family history of haemochromatosis or thalassemia or transferrin saturation (TSAT) >50%
2. Known reason for anaemia (e.g. untreated B12 or folate deficiency or haemoglobinopathy)
3. Known hypersensitivity to Monofer iron isomaltoside 1000 or its excipients
4. Severe asthma or severe allergy (requiring hospitalisation within the last 12 months)
5. Pregnancy or lactation
6. Inability to fully comprehend and/or perform study procedures in the investigator’s opinion
7. Participant involvement in another investigational medical product trial within the previous 4 weeks, that may impact on the results of this trial
8. Problem preventing or impacting upon exercise test
9. Will be changing training during the course of this research

Recruitment start date

01/09/2015

Recruitment end date

31/10/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

St Mary's University
Waldegrave Road
Twickenham
TW1 4SX
United Kingdom

Sponsor information

Organisation

St Mary's University

Sponsor details

Waldegrave Road
Twickenham
TW1 4SX
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Industry

Funder name

SCA-Libresse-Bodyform

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Pharmacosmos

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The plan is to publish the results for this study in a peer reviewed journal, alongside presenting the findings at conferences.

IPD Sharing plan:
For access to the datasets or for any other questions please contact:
Marisa Chau
UCL Division of Surgery & Interventional Science
4th Floor, UCL Medical School Building
21 University Street
London
WC1E 6AU
Email: m.chau@ucl.ac.uk

Intention to publish date

31/08/2019

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

05/10/2016: Participant information sheet uploaded.