Feasibility, safety and tolerability of intradialytic creatine supplementation in hemodialysis: A double-blind, randomized, placebo-controlled pilot study
Abstract
Background: Patients receiving hemodialysis are at risk of creatine deficiency due to impaired endogenous synthesis and losses during dialysis. Creatine deficiency is associated with lower health-related quality of life and higher mortality. We investigated the feasibility, tolerability and safety of intradialytic creatine supplementation during hemodialysis.
Methods: In this double-blind, randomized, placebo-controlled pilot study (ClinicalTrials.gov ID: NCT05148208), 16 hemodialysis patients were included into four sequentially initiated groups, with each group receiving a fixed creatine concentration in the dialysate (0.5 mmol/L, 1.0 mmol/L, 1.5 mmol/L and 2.0 mmol/L, respectively), with block randomization in a 3:1 ratio (creatine:placebo) per group. Dropouts were replaced. Intra-dialytic creatine was administered during a 6-week period. Primary outcomes were changes in pre-dialytic intra-erythrocytic and plasma creatine concentrations, which were analyzed with linear mixed models.
Results: 16 hemodialysis patients (aged 27-78 years, 9 female) completed the study. Creatine supplementation was generally well tolerated. One patient receiving 1.5 mmol/L creatine dropped out due to a potential side effect. No serious adverse events occurred. The median (minimum-maximum) baseline pre-dialytic intra-erythrocytic and plasma creatine concentrations were 963 (407-1822) and 35 (13-287) µmol/L, respectively. At 6 weeks, the changes in pre-dialytic intra-erythrocytic creatine…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 16 participants or records.
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