The 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.
Study Goal
The researchers aimed to evaluate whether intravenous iron supplementation reduces fatigue, improves muscle metabolism, and enhances exercise capacity and physical function in non-dialysis CKD patients with iron deficiency but without anemia.
Results Summary
The abstract reports baseline characteristics and study design but does not provide results on the effects of iron supplementation or exercise training.
Population
Non-dialysis stage 3-4 CKD patients with iron deficiency but without anemia, along with CKD non-iron deficient participants and healthy volunteers.
Effective Dosage
Not specified
Duration
12 weeks (with primary outcome measured at 4 weeks and additional exercise training between 4-12 weeks)
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
intravenous iron therapy | decrease | symptoms of fatigue | non-dialysis stage 3-4 CKD patients with iron deficiency but without anaemia | - | reduces | #1 |
intravenous iron therapy | increase | muscle metabolism | non-dialysis stage 3-4 CKD patients with iron deficiency but without anaemia | - | improves | #2 |
intravenous iron therapy | increase | exercise capacity | non-dialysis stage 3-4 CKD patients with iron deficiency but without anaemia | - | leads to enhanced | #3 |
intravenous iron therapy | increase | physical function | non-dialysis stage 3-4 CKD patients with iron deficiency but without anaemia | - | leads to enhanced | #4 |
intravenous iron therapy | increase | exercise capacity | non-dialysis patients with CKD who are iron-deficient but not anaemic | - | will address a substantial knowledge gap in the effects | #5 |
intravenous iron therapy | increase | physical function | non-dialysis patients with CKD who are iron-deficient but not anaemic | - | will address a substantial knowledge gap in the effects | #6 |
intravenous iron therapy | decrease | fatigue | non-dialysis patients with CKD who are iron-deficient but not anaemic | - | will address a substantial knowledge gap in the effects | #7 |
intravenous iron therapy | increase | muscle metabolism | non-dialysis patients with CKD who are iron-deficient but not anaemic | - | will address a substantial knowledge gap in the effects | #8 |
8-week exercise training programme | neutral | - | non-dialysis patients with CKD who are iron-deficient but not anaemic | - | will offer insight into the potential novel effects | #9 |
BACKGROUND: Many 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. METHODS: 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. RESULTS: 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 CONCLUSION: 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. TRIAL REGISTRATION: EudraCT: 2018-000,144-25 Registered 28/01/2019.