Iron deficiency Haematological Disorders
Conditions
Interventions
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
Sponsors
St Mary's University
Eligibility
Sex/Gender
Female
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
United Kingdom
Contacts
Public ContactGeorgie Bruinvels
Outcome results
None listed