IRONWOMAN- the effect of intravenous iron on performance outcomes, quality of life and mood states in iron deficient female athletes.

Not Applicable

Recruiting

• Conditions: Iron Deficiency; Iron Deficiency Anaemia; Public Health - Other public health; Blood - Anaemia; Metabolic and Endocrine - Other metabolic disorders

• Registration Number: ACTRN12620001357943
• Lead Sponsor: The University of Western Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-12-17
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 74

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in average VO2max max levels assessed by a treadmill exercise test using a validated metabolic cart.[(i) Baseline (ii) 4 days post (iii) 4 weeks post and (iv) 3 months post intervention<br>];Difference in change (delta) in VO2max assessed by a treadmill exercise test using a validated metabolic cart.[(i) Baseline (ii) 4 days post (iii) 4 weeks post and (iv) 3 months post intervention<br>]