NCT07033611

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2024

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

June 2, 2025

Completed
22 days until next milestone

First Posted

Study publicly available on registry

June 24, 2025

Completed
Last Updated

June 24, 2025

Status Verified

June 1, 2025

Enrollment Period

2 months

First QC Date

June 2, 2025

Last Update Submit

June 13, 2025

Conditions

Keywords

dialysispoor physical performancecreatinebody compositionShort Physical Performance Battery (SPPB)handgrip test

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

EXPERIMENTAL

patients before and after creatine suplemmentation

Dietary Supplement: Creatine

Interventions

CreatineDIETARY_SUPPLEMENT

Five grams of creatine were administered to each patient daily for eight weeks.

Pre creatine and post

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

Related Publications (27)

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    PMID: 28110688BACKGROUND
  • Johansen 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: 10844626BACKGROUND
  • Jain 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: 37615221BACKGROUND
  • Nowicka 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: 35566409BACKGROUND
  • Torino 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: 25118076BACKGROUND
  • Morishita 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: 28418625BACKGROUND
  • Kavanagh 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: 25731070BACKGROUND
  • Delanaye 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: 30090629BACKGROUND
  • Hultman 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: 8828669BACKGROUND
  • Kim 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: 21399917BACKGROUND
  • Liu 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: 34419517BACKGROUND
  • Bao 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: 22733312BACKGROUND
  • Kang 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: 35020730BACKGROUND
  • Kreider 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: 35268011BACKGROUND
  • Bucar 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: 28601123BACKGROUND
  • Pavasini 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: 28003033BACKGROUND
  • Beberashvili 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: 24736681BACKGROUND
  • Garlini 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: 29695763BACKGROUND
  • Uchida 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: 37923149BACKGROUND
  • van 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: 34444869BACKGROUND
  • Post 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: 33743724BACKGROUND
  • Post 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: 31083291BACKGROUND
  • Marini 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: 38474743BACKGROUND
  • Bossola 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: 27391964BACKGROUND
  • Marini 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: 31451266BACKGROUND
  • Vanden 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: 35588129BACKGROUND
  • Daugirdas 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

Creatine

Intervention Hierarchy (Ancestors)

GuanidinesAmidinesOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Carla Basualto-Alarcón, PhD

    Universidad de Aysén

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Functional assessments and bioelectrical impedance analysis conducted pre- and post-creatine supplementation
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.

Locations