None listed
Conditions
Brief summary
Background: Iron is a fundamental micronutrient for numerous human processes. However, approximately one third of the population is iron deficient. A deficiency in iron stores has been linked to significant decreases in work capacity, which, if left untreated, can progress to states of anaemia, whereby there is further detriment to work capacity and quality of life. Prevalence rates of iron deficiency in female athlete populations have been calculated to be higher than that of the general population (~50%), therefore, it is common for such individuals to utilise iron supplementation strategies to maintain iron homeostasis. However, the effects of iron repletion strategies on physical performance and quality of life continue to remain latent to modern research. This study therefore aims to elucidate such effects. Methods: The IRONWOMAN trial will utilise a double blind, randomised control design to investigate the effects of IV iron therapy on performance outcomes, quality of life and mood states in iron deficient recreational female athletes. Potential participants will be screened from the general population at universities and sporting events via the use of a female health questionnaire. Participants, who provide informed consent, will undergo familiarisation followed by baseline testing, which will involve a graded exercise test (GXT), survey completion, and a total haemoglobin mass test, using the optimised carbon monoxide rebreathing technique. Venous blood samples will be collected both prior to and post-GXT. Following this, participants will be randomly assigned to either an IV therapy group (to receive 20 mg/kg of body weight ferric derisomaltose) or a placebo group (receiving 100 ml/saline). Follow up assessments utilising the baseline test protocol will occur at 4 days post-, 4 weeks post-, and 6 months post- intervention. Discussion: The outcomes of this research will generate the necessary empirical evidence to resolve the divergence of current literature. Indeed, results of this clinical trial will contribute towards the identification of a threshold value which elucidates the ability of IV iron therapy to improve the performance of a given individual, depending on markers of iron status. As a result, more informed decisions can be made regarding athlete iron supplementation strategies.
Interventions
An intervention will be used, as per the protocol document (also described below).
The population being studied is all female athletes with iron deficiency, half of whom will be randomised to treatment of their iron deficiency. The comparators will be the interventions before and after randomisation of treatment.
Intervention description: Iron treatment (single injection; ~90 minutes).
Participants who conform to all eligibility criteria and have provided written informed consent will be ran
An intervention will be used, as per the protocol document (also described below). The population being studied is all female athletes with iron deficiency, half of whom will be randomised to treatment of their iron deficiency. The comparators will be the interventions before and after randomisation of treatment. Intervention description: Iron treatment (single injection; ~90 minutes). Participants who conform to all eligibility criteria and have provided written informed consent will be randomised to receive either intravenous iron or placebo. Intervention will take place at the WA Iron Centre (374 Belgravia street, Cloverdale), under the clinical care of Dr. Pradeep Jayasuriya (AHPRA: MED0001577032; Provider number: 002079AY). Administration will be given in a registered clinic (as described above) with appropriate resuscitation facility and staff available in the event of an emergency. Participants will be administered the study medication by the unblinded person. For the drug administration the patient will have an intravenous line sited. Following this it is advised that the skin along the donor vein will be wiped using an iodine swab to help maintain the blind. The patient is to be shielded from seeing preparation of the study drug, drug administration, disconnection and removal of the intravenous line. Participants should be closely monitored as per clinic protocols throughout administration of the treatment. 1. Monofer group: 1000 mg of iron isomaltoside will be administered as an intravenous infusion (100ml n/saline) over a minimum of 15 minutes using a black infusion kit. 2. Placebo group: Normal saline will be administered as an IV infusion (100ml n/saline) over a minimum of 15 minutes using a black infusion kit. Adverse events occurring in connection with the administration of study medication will be recorded. In the event of a patient having an allergic reaction or signs of intolerance during study drug administration, the investigator must follow local protocols. If appropriate, the investigator should complete and submit a serious adverse event (SAE) report as per trial protocol. It should be noted that adverse events will not be assessed as an outcome for the current study. If the treatment is stopped for other reasons and the patient is willing, then treatment can be restarted where possible (as per local practice).
Sponsors
The University of Western Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
Participants who are successfully screened and meet the following criteria are eligible for the study: 1. Female 2. At least 18 years of age 3. Screening haemoglobin concentration [Hb] greater than or equal to 90 g/L (9.0 g/dL) but below or equal to 130 g/L (13.0 g/dL) 4. Screening ferritin below 20 ug/L 5. Undertake at least 3 hours of regular exercise a week
Exclusion criteria
Participants who, at the start of treatment, meet any of the following criteria are not eligible for the study: 1. Other known reason for anaemia (e.g. untreated B12 or folate deficiency or haemoglobinopathy). 2. Known history of acquired iron overload, or family history of haemochromatosis or thalassemia or TSAT (transferrin saturation) > 50%. 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.
Outcome results
None listed