IRONWOMAN: the impact of iron deficiency in exercising wome

Phase 1

Completed

Conditions: Iron deficiency
Haematological Disorders

Registration Number: ISRCTN14032359

Lead Sponsor: St Mary's University

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 35

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

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

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in VO2max (maximum volume of oxygen) at 2 weeks (+/- 1 week) post-intervention<br><br>The VO2max test will consist of two parts, as described below. <br>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)<br>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

Name	Time	Method
From baseline to 2 weeks (+/- 1 week) post-intervention<br><br>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<br>2. Change in haemoglobin levels (blood test)<br>3. Change in markers of iron status (blood test)<br>4. Change in FBC parameters (blood test)<br>5. Change in health-related quality of life or HRQoL, assessed using questionnaires EQ-5D-5L and SQOM<br>6. Change in thbmass and blood volume (tHbmass test)<br>7. Change in urinary fractional excretion of phosphate (urine samples)<br>8. Change in mood (BRUMS Mood Questionnaire)