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dc.contributor.authorGreenwood, Sharlene A
dc.contributor.authorBeckley-Hoelscher, Nicholas
dc.contributor.authorAsgari, Elham
dc.contributor.authorAyis, Salma
dc.contributor.authorBaker, Luke A
dc.contributor.authorBanerjee, Debasish
dc.contributor.authorBhandari, Sunil
dc.contributor.authorBramham, Kate
dc.contributor.authorChilcot, Joseph
dc.contributor.authorBurton, James
dc.contributor.authorKalra, Philip A
dc.contributor.authorLightfoot, Courtney J
dc.contributor.authorMcCafferty, Kieran
dc.contributor.authorMercer, Thomas H
dc.contributor.authorOkonko, Darlington O
dc.contributor.authorOliveira, Benjamin
dc.contributor.authorReid, Chante
dc.contributor.authorSmith, Alice C
dc.contributor.authorSwift, Pauline A
dc.contributor.authorMangelis, Anastasios
dc.contributor.authorWatson, Emma
dc.contributor.authorWheeler, David C
dc.contributor.authorWilkinson, Thomas J
dc.contributor.authorReid, Fiona
dc.contributor.authorMacdougall, Iain C
dc.identifierpubmed: 35896969
dc.identifierdoi: 10.1186/s12882-022-02896-3
dc.identifierpii: 10.1186/s12882-022-02896-3
dc.identifierpmc: PMC9325952
dc.identifier.citationBMC nephrology, volume 23, issue 1, page 268, article-number 10.1186/s12882-022-02896-3
dc.descriptionFrom PubMed via Jisc Publications Router
dc.descriptionHistory: received 2022-03-22, accepted 2022-07-04
dc.descriptionPublication status: epublish
dc.description.abstractMany people living with chronic kidney disease (CKD) are iron deficient, even though they may not be anaemic. The Iron and Muscle study aims to evaluate whether iron supplementation reduces symptoms of fatigue, improves muscle metabolism, and leads to enhanced exercise capacity and physical function. We report here the trial design and baseline characteristics. This is a prospective, double-blind multicentre randomised controlled trial (RCT) including 75 non-dialysis stage 3-4 CKD patients with iron deficiency but without anaemia. Patients were randomly (1:1) assigned to either: i) intravenous iron therapy, or ii) placebo, with concurrent recruitment of eight CKD non-iron deficient participants and six healthy volunteers. The primary outcome of the study is the six-minute walk test (6MWT) distance between baseline and four-weeks. An additional exercise training programme for patients in both groups was initiated and completed between 4 and 12 weeks, to determine the effect of iron repletion compared to placebo treatment in the context of patients undertaking an exercise programme. Additional secondary outcomes include fatigue, physical function, muscle strength, muscle metabolism, quality of life, resting blood pressure, clinical chemistry, safety and harms associated with the iron therapy intervention and the exercise training intervention, and hospitalisations. All outcomes were conducted at baseline, 4, and 12 weeks, with a nested qualitative study, to investigate the experience of living with iron deficiency and intervention acceptability. The cohort have been recruited and baseline assessments undertaken. Seventy-five individuals were recruited. 44% of the randomised cohort were male, the mean (SD) age was 58 (14) years, and 56% were White. Body mass index was 31 (7) kg/m ; serum ferritin was 59 (45) μg/L, transferrin saturation was 22 (10) %, and haemoglobin was 125 (12) g/L at randomisation for the whole group. Estimated glomerular filtration rate was 35 (12) mL/min/1.73 m and the baseline 6MWT distance was 429 (174) m. The results from this study will address a substantial knowledge gap in the effects of intravenous iron therapy, and offer potential clinical treatment options, to improve exercise capacity, physical function, fatigue, and muscle metabolism, for non-dialysis patients with CKD who are iron-deficient but not anaemic. It will also offer insight into the potential novel effects of an 8-week exercise training programme. EudraCT: 2018-000,144-25 Registered 28/01/2019. [Abstract copyright: © 2022. The Author(s).]
dc.sourceeissn: 1471-2369
dc.subjectMagnetic resonance imaging
dc.subjectRenal Insufficiency, Chronic - complications - drug therapy
dc.subjectChronic kidney disease
dc.subjectMuscle metabolism
dc.subjectDietary Supplements
dc.subjectTreatment Outcome
dc.subjectMiddle Aged
dc.subjectQuality of life
dc.subjectIron Deficiencies
dc.subjectDouble-Blind Method
dc.subjectExercise Tolerance
dc.subjectPhysical activity
dc.titleThe effect of intravenous iron supplementation on exercise capacity in iron-deficient but not anaemic patients with chronic kidney disease: study design and baseline data for a multicentre prospective double-blind randomised controlled trial.

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