Effects of Short Term Creatine Supplementation in Hemodialysis Patients
Effects of Creatine Supplementation in Sarcopenic and Non-sarcopenic Patients on Chronic Hemodialysis
1 other identifier
interventional
18
1 country
1
Brief Summary
Adult patients undergoing chronic dialysis therapy for at least three months were selected. A physical function assessment was conducted, including the Short Physical Performance Battery (SPPB) and a handgrip strength test. Additionally, a bioelectrical impedance analysis was performed. Subsequently, 5 grams of creatine were administered daily for a period of eight weeks, after which the same assessments were repeated. The results were then analyzed to identify any differences in the tests, aiming to detect potential changes following creatine supplementation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2024
CompletedFirst Submitted
Initial submission to the registry
June 2, 2025
CompletedFirst Posted
Study publicly available on registry
June 24, 2025
CompletedJune 24, 2025
June 1, 2025
2 months
June 2, 2025
June 13, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Compare Short Physical Performance Battery (SPPB) before and after 8 weeks of creatine use
To compare the physical functionality status of selected patients, as assessed by the Short Physical Performance Battery (SPPB), before and after eight weeks of creatine supplementation. Scale range between 0-12 points. Higher points mean a better outcome (higher physical functionality).
eigth weeks
Secondary Outcomes (7)
Compare hand grip strength as assessed by a hand dynamometer, before and after eight weeks of creatine supplementation
eigth weeks
Compare body composition: skeletal muscle mass, estimated by bioimpedance analysis before and after eight weeks of creatine supplementation
eigth weeks
Compare body composition: fat free mass, estimated by bioimpedance analysis before and after eight weeks of creatine supplementation
eigth weeks
Compare body composition: total body water (Lt), estimated by bioimpedance analysis before and after eight weeks of creatine supplementation
eigth weeks
Compare body composition: extracellular water (Lt), estimated by bioimpedance analysis before and after eight weeks of creatine supplementation
eigth weeks
- +2 more secondary outcomes
Study Arms (1)
Pre creatine and post
EXPERIMENTALpatients before and after creatine suplemmentation
Interventions
Five grams of creatine were administered to each patient daily for eight weeks.
Eligibility Criteria
You may qualify if:
- Eligible to provide informed consent
- At least three months on chronic dialysis therapy
- No physical impairments that would prevent completion of the SPPB or bioelectrical impedance analysis
You may not qualify if:
- Pregnancy
- Use of any nutritional supplement
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital de Puerto Aysen
Puerto Aisén, Región de Aysen, Chile
Related Publications (27)
Wallimann T, Riek U, Moddel M. Intradialytic creatine supplementation: A scientific rationale for improving the health and quality of life of dialysis patients. Med Hypotheses. 2017 Feb;99:1-14. doi: 10.1016/j.mehy.2016.12.002. Epub 2016 Dec 7.
PMID: 28110688BACKGROUNDJohansen KL, Chertow GM, Ng AV, Mulligan K, Carey S, Schoenfeld PY, Kent-Braun JA. Physical activity levels in patients on hemodialysis and healthy sedentary controls. Kidney Int. 2000 Jun;57(6):2564-70. doi: 10.1046/j.1523-1755.2000.00116.x.
PMID: 10844626BACKGROUNDJain N, Bansal R, Saxena S, Sharma S, Raju SB. Predictors of functional impairment and mortality in patients on maintenance hemodialysis. Semin Dial. 2024 Mar-Apr;37(2):138-144. doi: 10.1111/sdi.13173. Epub 2023 Aug 24.
PMID: 37615221BACKGROUNDNowicka M, Gorska M, Edyko K, Szklarek-Kubicka M, Kazanek A, Prylinska M, Niewodniczy M, Kostka T, Kurnatowska I. Association of Physical Performance, Muscle Strength and Body Composition with Self-Assessed Quality of Life in Hemodialyzed Patients: A Cross-Sectional Study. J Clin Med. 2022 Apr 20;11(9):2283. doi: 10.3390/jcm11092283.
PMID: 35566409BACKGROUNDTorino C, Manfredini F, Bolignano D, Aucella F, Baggetta R, Barilla A, Battaglia Y, Bertoli S, Bonanno G, Castellino P, Ciurlino D, Cupisti A, D'Arrigo G, De Paola L, Fabrizi F, Fatuzzo P, Fuiano G, Lombardi L, Lucisano G, Messa P, Rapana R, Rapisarda F, Rastelli S, Rocca-Rey L, Summaria C, Zuccala A, Tripepi G, Catizone L, Zoccali C, Mallamaci F; EXCITE Working Group. Physical performance and clinical outcomes in dialysis patients: a secondary analysis of the EXCITE trial. Kidney Blood Press Res. 2014;39(2-3):205-11. doi: 10.1159/000355798. Epub 2014 Jul 29.
PMID: 25118076BACKGROUNDMorishita S, Tsubaki A, Shirai N. Physical function was related to mortality in patients with chronic kidney disease and dialysis. Hemodial Int. 2017 Oct;21(4):483-489. doi: 10.1111/hdi.12564. Epub 2017 Apr 18.
PMID: 28418625BACKGROUNDKavanagh NT, Schiller B, Saxena AB, Thomas IC, Kurella Tamura M. Prevalence and correlates of functional dependence among maintenance dialysis patients. Hemodial Int. 2015 Oct;19(4):593-600. doi: 10.1111/hdi.12286. Epub 2015 Mar 2.
PMID: 25731070BACKGROUNDDelanaye P, Quinonez K, Buckinx F, Krzesinski JM, Bruyere O. Hand grip strength measurement in haemodialysis patients: before or after the session? Clin Kidney J. 2018 Aug;11(4):555-558. doi: 10.1093/ckj/sfx139. Epub 2017 Dec 19.
PMID: 30090629BACKGROUNDHultman E, Soderlund K, Timmons JA, Cederblad G, Greenhaff PL. Muscle creatine loading in men. J Appl Physiol (1985). 1996 Jul;81(1):232-7. doi: 10.1152/jappl.1996.81.1.232.
PMID: 8828669BACKGROUNDKim HJ, Kim CK, Carpentier A, Poortmans JR. Studies on the safety of creatine supplementation. Amino Acids. 2011 May;40(5):1409-18. doi: 10.1007/s00726-011-0878-2. Epub 2011 Mar 12.
PMID: 21399917BACKGROUNDLiu CK, Seo J, Lee D, Wright K, Tamura MK, Moye JA, Bean JF, Weiner DE. Mobility in Older Adults Receiving Maintenance Hemodialysis: A Qualitative Study. Am J Kidney Dis. 2022 Apr;79(4):539-548.e1. doi: 10.1053/j.ajkd.2021.07.010. Epub 2021 Aug 20.
PMID: 34419517BACKGROUNDBao Y, Dalrymple L, Chertow GM, Kaysen GA, Johansen KL. Frailty, dialysis initiation, and mortality in end-stage renal disease. Arch Intern Med. 2012 Jul 23;172(14):1071-7. doi: 10.1001/archinternmed.2012.3020.
PMID: 22733312BACKGROUNDKang SH, Do JY, Kim JC. Impedance-derived phase angle is associated with muscle mass, strength, quality of life, and clinical outcomes in maintenance hemodialysis patients. PLoS One. 2022 Jan 12;17(1):e0261070. doi: 10.1371/journal.pone.0261070. eCollection 2022.
PMID: 35020730BACKGROUNDKreider RB, Jager R, Purpura M. Bioavailability, Efficacy, Safety, and Regulatory Status of Creatine and Related Compounds: A Critical Review. Nutrients. 2022 Feb 28;14(5):1035. doi: 10.3390/nu14051035.
PMID: 35268011BACKGROUNDBucar Pajek M, Cuk I, Mlinsek G, Osredkar J, Pajek J. Physical function and 25-hydroxyvitamin D in dialysis patients - lessons learned from the Slovenian DIAGIB study. Clin Nephrol. 2017 Supplement 1;88(13):48-52. doi: 10.5414/CNP88FX12.
PMID: 28601123BACKGROUNDPavasini R, Guralnik J, Brown JC, di Bari M, Cesari M, Landi F, Vaes B, Legrand D, Verghese J, Wang C, Stenholm S, Ferrucci L, Lai JC, Bartes AA, Espaulella J, Ferrer M, Lim JY, Ensrud KE, Cawthon P, Turusheva A, Frolova E, Rolland Y, Lauwers V, Corsonello A, Kirk GD, Ferrari R, Volpato S, Campo G. Short Physical Performance Battery and all-cause mortality: systematic review and meta-analysis. BMC Med. 2016 Dec 22;14(1):215. doi: 10.1186/s12916-016-0763-7.
PMID: 28003033BACKGROUNDBeberashvili I, Azar A, Sinuani I, Shapiro G, Feldman L, Stav K, Sandbank J, Averbukh Z. Bioimpedance phase angle predicts muscle function, quality of life and clinical outcome in maintenance hemodialysis patients. Eur J Clin Nutr. 2014 Jun;68(6):683-9. doi: 10.1038/ejcn.2014.67. Epub 2014 Apr 16.
PMID: 24736681BACKGROUNDGarlini LM, Alves FD, Ceretta LB, Perry IS, Souza GC, Clausell NO. Phase angle and mortality: a systematic review. Eur J Clin Nutr. 2019 Apr;73(4):495-508. doi: 10.1038/s41430-018-0159-1. Epub 2018 Apr 26.
PMID: 29695763BACKGROUNDUchida J, Suzuki Y, Imamura K, Yoshikoshi S, Nakajima T, Fukuzaki N, Harada M, Kamiya K, Matsuzawa R, Matsunaga A. The Association of Short Physical Performance Battery With Mortality and Hospitalization in Patients Receiving Hemodialysis. J Ren Nutr. 2024 May;34(3):235-242. doi: 10.1053/j.jrn.2023.10.010. Epub 2023 Nov 3.
PMID: 37923149BACKGROUNDvan der Veen Y, Post A, Kremer D, Koops CA, Marsman E, Appeldoorn TYJ, Touw DJ, Westerhuis R, Heiner-Fokkema MR, Franssen CFM, Wallimann T, Bakker SJL. Chronic Dialysis Patients Are Depleted of Creatine: Review and Rationale for Intradialytic Creatine Supplementation. Nutrients. 2021 Aug 6;13(8):2709. doi: 10.3390/nu13082709.
PMID: 34444869BACKGROUNDPost A, Schutten JC, Kremer D, van der Veen Y, Groothof D, Sotomayor CG, Koops CA, de Blaauw P, Kema IP, Westerhuis R, Wallimann T, Heiner-Fokkema MR, Bakker SJL, Franssen CFM. Creatine homeostasis and protein energy wasting in hemodialysis patients. J Transl Med. 2021 Mar 20;19(1):115. doi: 10.1186/s12967-021-02780-y.
PMID: 33743724BACKGROUNDPost A, Tsikas D, Bakker SJL. Creatine is a Conditionally Essential Nutrient in Chronic Kidney Disease: A Hypothesis and Narrative Literature Review. Nutrients. 2019 May 10;11(5):1044. doi: 10.3390/nu11051044.
PMID: 31083291BACKGROUNDMarini ACB, Schincaglia RM, Candow DG, Pimentel GD. Effect of Creatine Supplementation on Body Composition and Malnutrition-Inflammation Score in Hemodialysis Patients: An Exploratory 1-Year, Balanced, Double-Blind Design. Nutrients. 2024 Feb 23;16(5):615. doi: 10.3390/nu16050615.
PMID: 38474743BACKGROUNDBossola M, Di Stasio E, Antocicco M, Pepe G, Tazza L, Zuccala G, Laudisio A. Functional impairment is associated with an increased risk of mortality in patients on chronic hemodialysis. BMC Nephrol. 2016 Jul 8;17(1):72. doi: 10.1186/s12882-016-0302-y.
PMID: 27391964BACKGROUNDMarini ACB, Pimentel GD. Is body weight or muscle strength correlated with the Malnutrition Inflammation Score (MIS)? A cross-sectional study in hemodialysis patients. Clin Nutr ESPEN. 2019 Oct;33:276-278. doi: 10.1016/j.clnesp.2019.07.009. Epub 2019 Aug 2.
PMID: 31451266BACKGROUNDVanden Wyngaert K, Van Biesen W, Eloot S, Van Craenenbroeck AH, Calders P, Holvoet E. The importance of physical performance in the assessment of patients on haemodialysis: A survival analysis. PLoS One. 2022 May 19;17(5):e0268115. doi: 10.1371/journal.pone.0268115. eCollection 2022.
PMID: 35588129BACKGROUNDDaugirdas JT, Leypoldt JK, Akonur A, Greene T, Depner TA; FHN Trial Group. Improved equation for estimating single-pool Kt/V at higher dialysis frequencies. Nephrol Dial Transplant. 2013 Aug;28(8):2156-60. doi: 10.1093/ndt/gfs115. Epub 2012 May 4.
PMID: 22561585BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carla Basualto-Alarcón, PhD
Universidad de Aysén
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor, U Aysen. MD., MSc., PhD.
Study Record Dates
First Submitted
June 2, 2025
First Posted
June 24, 2025
Study Start
January 1, 2024
Primary Completion
February 28, 2024
Study Completion
February 28, 2024
Last Updated
June 24, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will share
At the time of paper submission, all data will be shared in an anonymized form, as supplementary material.