The effect of iron deficiency on functional performance outcome measures and quality of life in exercising women

St Mary's University0 个研究点目标入组 35 人开始时间: 2016年9月23日最近更新: 2017年9月4日

适应症

试验速览

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•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

•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

发起方

St Mary's University