Financiado en parte por Crearene AG
Feasibility, safety and tolerability of intradialytic creatine supplementation in hemodialysis: A double-blind, randomized, placebo-controlled pilot study
Doorenbos CSE, van der Veen Y, Post A, Jonker J, Knobbe TJ, Kremer D, Groothof D, Heiner-Fokkema MR, Koops CA, Bijsterveld K, Marsman E, Hazenberg IT, Manson NA, Appeldoorn TYJ, Boersma HH, Dekkers BGJ, Touw DJ, Wallimann T, Franssen CFM, Bakker SJL
PloS one · 0 citas
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Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiado por la industria
- Universidad u hospital
- Universitair Medisch Centrum Groningen
- Empresa
- Crearene AG
Según 2 financiadores declarados y la declaración de financiación del texto completo.
Publicación
- Publicado
- 2026-08-05 · PLoS One · vol. 21 · número 8 · pág. e0354883
- Editorial
- Public Library of Science
- Citado
- 0 citas · más que el 61% de estudios similares · 0.0× el promedio de su campo
- Referencias
- 31 trabajos
- Acceso
- Acceso abierto (revista) · CC-BY
- Áreas de investigación
- Dialysis and Renal Disease Management · Muscle metabolism and nutrition · Clinical Nutrition and Gastroenterology
- Palabras clave
- hemodialysis, creatine deficiency, plasma creatine, safety and tolerability, end-stage renal disease, creatine deficiency syndrome, health-related quality of life, mortality risk, pilot study, adverse events
- MeSH
- humans, creatine, renal dialysis, feasibility studies, pilot projects, double-blind method, quality of life, dietary supplements, adult, aged, middle aged, female, male
20 autores
- Caecilia S E Doorenbos🇳🇱 · autor de correspondenciaUniversity Medical Center Groningen; University of Groningen
- Yvonne van der Veen🇳🇱University Medical Center Groningen; University of Groningen
- Adrian Post🇳🇱University Medical Center Groningen; University of Groningen
- Jip Jonker🇳🇱University Medical Center Groningen; University of Groningen
- Tim J. Knobbe🇳🇱University Medical Center Groningen; University of Groningen
- Daan Kremer🇳🇱University Medical Center Groningen; University of Groningen
- Dion Groothof🇳🇱University Medical Center Groningen; University of Groningen
- Margaretha Rebecca Heiner-Fokkema🇳🇱University Medical Center Groningen; University of Groningen
- Christa A. Koops🇳🇱University Medical Center Groningen; University of Groningen
- Klaas Bijsterveld🇳🇱University Medical Center Groningen; University of Groningen
- Erik Marsman🇳🇱Dialyse Centrum Groningen
- Ietje T. Hazenberg🇳🇱Dialyse Centrum Groningen
- Nienke A. Manson🇳🇱Dialyse Centrum Groningen
- Theo Y. Jerôme Appeldoorn🇳🇱University Medical Center Groningen; University of Groningen
- Hendrikus Hessel Boersma🇳🇱University Medical Center Groningen; University of Groningen
- Bart G. J. Dekkers🇳🇱University Medical Center Groningen; University of Groningen
- Daan Johannes Touw🇳🇱University Medical Center Groningen; University of Groningen
- Theo Wallimann🇨🇭ETH Zurich
- Casper F. M. Franssen🇳🇱University Medical Center Groningen; University of Groningen
- Stephan J. L. Bakker🇳🇱University Medical Center Groningen; University of Groningen
Resumen
El texto original del estudio, en el idioma en que se publicó.
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 concentration compared to placebo (95% CI) were +399 (-269, 1066), + 685 (+17, + 1352), + 1146 (+431, + 1766) and +1098 (+431, + 1766) µmol/L for the increasing dosage treatment groups respectively (overall treatment effect p < 0.001). The changes in pre-dialytic plasma creatine concentration compared to placebo were -16 (-301, + 270), + 21 (-264, + 307), + 119 (-264, + 307) and +163 (-122, + 449) µmol/L for the increasing dosage treatment groups respectively (overall treatment effect p = 0.002).
Conclusion
Intra-dialytic creatine supplementation is a feasible, safe, well-tolerated method to increase circulating creatine concentrations in patients treated with hemodialysis. These findings support the rationale for a larger randomized controlled trial to investigate its potential to improve health-related quality of life and reduce mortality risk in this population. Trial Registration: ClinicalTrials.gov ID NCT05148208, date of first registration 08/12/2021.
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