Dialysis; ComplicationsNCT07033611
Effects of Short Term Creatine Supplementation in Hemodialysis Patients
A study testing Creatine in people with Dialysis; Complications and Performance Enhancing Product Use, run by Carla Basualto Alarcón at 1 site in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dialysis; Complications, Performance Enhancing Product Use
- What is being tested?
- Creatine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChile
- Study dates
- 1 Jan 2024to 28 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnancy
- Use of any nutritional supplement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Creatine Supplementation in Sarcopenic and Non-sarcopenic Patients on Chronic Hemodialysis
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.
Read the detailed description
Adult patients undergoing chronic dialysis therapy for at least three months were selected, primarily based on their good adherence to pharmacological and dialysis treatment regimens. 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.
All participants were informed that creatine would be administered and provided written informed consent. The study protocol was approved by the local ethics committee.
Creatine supplementation consisted of 5 grams per day for eight weeks. On dialysis days, the dose was administered immediately after the dialysis session. On non-dialysis days, patients were responsible for self-administering the creatine at home. The creatine was diluted in 100 mL of water before ingestion.
All assessments were conducted the day following the second dialysis session of the week-on Thursday or Friday, depending on the patient's schedule. There was no control group so pre-creatine measurements were considered as the basal (control) state. Measurements were taken before and after the creatine supplementation period in the same patients. The data were analyzed to evaluate changes in the outcomes following creatine use.
- Being tested
- Creatine
- Keywords
- dialysis, poor physical performance, creatine, body composition, Short Physical Performance Battery (SPPB), handgrip test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CreatineDietary supplement
Five grams of creatine were administered to each patient daily for eight weeks.
| Study group | Role | What they receive |
|---|---|---|
| Pre creatine and post | Experimental | patients before and after creatine suplemmentation Receives: Dietary Supplement: Creatine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: eigth weeks
Secondary outcomes (7)
Compare hand grip strength as assessed by a hand dynamometer, before and after eight weeks of creatine supplementation
compare changes in muscle strength, measured using a hand dynamometer.
Measured: eigth weeks
Compare body composition: skeletal muscle mass, estimated by bioimpedance analysis before and after eight weeks of creatine supplementation
Compare changes in skeletal muscle mass (Kg), estimated by bioimpedance analysis before and after eight weeks of creatine supplementation
Measured: eigth weeks
Compare body composition: fat free mass, estimated by bioimpedance analysis before and after eight weeks of creatine supplementation
Compare changes in fat free mass (Kg), estimated by bioimpedance analysis before and after
Measured: eigth weeks
Compare body composition: total body water (Lt), estimated by bioimpedance analysis before and after eight weeks of creatine supplementation
Compare changes in tota body water (Lt), estimated by bioimpedance analysis before and after
Measured: eigth weeks
Compare body composition: extracellular water (Lt), estimated by bioimpedance analysis before and after eight weeks of creatine supplementation
Compare changes in extracellular water (Lt), estimated by bioimpedance analysis before and after
Measured: eigth weeks
Compare body composition: intracellular water (Lt), estimated by bioimpedance analysis before and after eight weeks of creatine supplementation
Compare changes in intracellular water (Lt), estimated by bioimpedance analysis before and after
Measured: eigth weeks
Compare body composition: phase angle (degrees), estimated by bioimpedance analysis before and after eight weeks of creatine supplementation
Compare changes in phase angle (degrees), estimated by bioimpedance analysis before and after
Measured: eigth weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start1 Jan 2024
- Primary completion28 Feb 2024
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Dialysis; ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Functional assessments and bioelectrical impedance analysis conducted pre- and post-creatine supplementation
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carla Basualto Alarcón
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Carla Basualto Alarcón, Universidad de Aysén
- Investigators
- Carla Basualto-Alarcón, PhD, Principal investigator, Universidad de Aysén
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07033611
- Sponsor's protocol ID
- ORD252023
- Status last verified
- Jun 2025
- First submitted
- 2 Jun 2025
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: At the time of paper submission, all data will be shared in an anonymized form, as supplementary material.
Publications
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.
PubMed 28110688Johansen 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.
PubMed 10844626Jain 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.
PubMed 37615221Nowicka 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.
PubMed 35566409Torino 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.
PubMed 25118076Morishita 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.
PubMed 28418625Kavanagh 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.
PubMed 25731070Delanaye 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.
PubMed 30090629Hultman 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.
PubMed 8828669Kim 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.
PubMed 21399917Liu 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.
PubMed 34419517Bao 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.
PubMed 22733312Kang 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.
PubMed 35020730Kreider 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.
PubMed 35268011Bucar 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.
PubMed 28601123
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Creatine Supplementation in Sarcopenic and Non-sarcopenic Patients on Chronic Hemodialysis
- ClinicalTrials.gov ID
- NCT07033611
- Acronym / sponsor ID
- ORD252023
- Keywords
- dialysis, poor physical performance, creatine, body composition, Short Physical Performance Battery (SPPB), handgrip test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Carla Basualto AlarcónUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 24 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Adult patients undergoing chronic dialysis therapy for at least three months were selected, primarily based on their good adherence to pharmacological and dialysis treatment regimens. 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.
All participants were informed that creatine would be administered and provided written informed consent. The study protocol was approved by the local ethics committee.
Creatine supplementation consisted of 5 grams per day for eight weeks. On dialysis days, the dose was administered immediately after the dialysis session. On non-dialysis days, patients were responsible for self-administering the creatine at home. The creatine was diluted in 100 mL of water before ingestion.
All assessments were conducted the day following the second dialysis session of the week-on Thursday or Friday, depending on the patient's schedule. There was no control group so pre-creatine measurements were considered as the basal (control) state. Measurements were taken before and after the creatine supplementation period in the same patients. The data were analyzed to evaluate changes in the outcomes following creatine use.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Functional assessments and bioelectrical impedance analysis conducted pre- and post-creatine supplementation
| Arm | Type | Receives |
|---|---|---|
| Pre creatine and post | Experimental | Dietary Supplement: Creatinepatients before and after creatine suplemmentation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Pregnancy
- Use of any nutritional supplement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CreatineFive grams of creatine were administered to each patient daily for eight weeks. | Dietary supplement | Pre creatine and post |
Primary outcome
Compare Short Physical Performance Battery (SPPB) before and after 8 weeks of creatine use
Time frame: eigth weeks
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).
7 secondary outcomes
Compare hand grip strength as assessed by a hand dynamometer, before and after eight weeks of creatine supplementation
Time frame: eigth weeks
Compare body composition: skeletal muscle mass, estimated by bioimpedance analysis before and after eight weeks of creatine supplementation
Time frame: eigth weeks
Compare body composition: fat free mass, estimated by bioimpedance analysis before and after eight weeks of creatine supplementation
Time frame: eigth weeks
Compare body composition: total body water (Lt), estimated by bioimpedance analysis before and after eight weeks of creatine supplementation
Time frame: eigth weeks
Compare body composition: extracellular water (Lt), estimated by bioimpedance analysis before and after eight weeks of creatine supplementation
Time frame: eigth weeks
Compare body composition: intracellular water (Lt), estimated by bioimpedance analysis before and after eight weeks of creatine supplementation
Time frame: eigth weeks
Compare body composition: phase angle (degrees), estimated by bioimpedance analysis before and after eight weeks of creatine supplementation
Time frame: eigth weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- Background: PubMed 28110688Wallimann 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.
- Background: PubMed 10844626Johansen 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.
- Background: PubMed 37615221Jain 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.
- Background: PubMed 35566409Nowicka 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.
- Background: PubMed 25118076Torino 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.
- Background: PubMed 28418625Morishita 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.
- Background: PubMed 25731070Kavanagh 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.
- Background: PubMed 30090629Delanaye 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.
- Background: PubMed 8828669Hultman 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.
- Background: PubMed 21399917Kim 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.
- Background: PubMed 34419517Liu 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.
- Background: PubMed 22733312Bao 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.
- Individual participant dataSharing planned: Yes. At the time of paper submission, all data will be shared in an anonymized form, as supplementary material.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carla Basualto-Alarcón, PhD principal investigator
Universidad de Aysén
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Creatine in people with Dialysis; Complications and Performance Enhancing Product Use, run by Carla Basualto Alarcón at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare Short Physical Performance Battery (SPPB) before and after 8 weeks of creatine use (time frame: eigth weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07033611, which also lists 27 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2025.