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Completed

NCT Number: NCT07033611

Effects of Short Term Creatine Supplementation in Hemodialysis Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de Puerto Aysen

Puerto Aisén, Región de Aysen, Chile

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Pregnancy
  • Use of any nutritional supplement

Treatment and study plan

Creatine

Dietary Supplement

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

Primary outcomes

  1. 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).

Secondary outcomes

  1. Compare hand grip strength as assessed by a hand dynamometer, before and after eight weeks of creatine supplementation

    Time frame: eigth weeks

    compare changes in muscle strength, measured using a hand dynamometer.

  2. Compare body composition: skeletal muscle mass, estimated by bioimpedance analysis before and after eight weeks of creatine supplementation

    Time frame: eigth weeks

    Compare changes in skeletal muscle mass (Kg), estimated by bioimpedance analysis before and after eight weeks of creatine supplementation

  3. Compare body composition: fat free mass, estimated by bioimpedance analysis before and after eight weeks of creatine supplementation

    Time frame: eigth weeks

    Compare changes in fat free mass (Kg), estimated by bioimpedance analysis before and after

  4. Compare body composition: total body water (Lt), estimated by bioimpedance analysis before and after eight weeks of creatine supplementation

    Time frame: eigth weeks

    Compare changes in tota body water (Lt), estimated by bioimpedance analysis before and after

  5. Compare body composition: extracellular water (Lt), estimated by bioimpedance analysis before and after eight weeks of creatine supplementation

    Time frame: eigth weeks

    Compare changes in extracellular water (Lt), estimated by bioimpedance analysis before and after

  6. Compare body composition: intracellular water (Lt), estimated by bioimpedance analysis before and after eight weeks of creatine supplementation

    Time frame: eigth weeks

    Compare changes in intracellular water (Lt), estimated by bioimpedance analysis before and after

  7. Compare body composition: phase angle (degrees), estimated by bioimpedance analysis before and after eight weeks of creatine supplementation

    Time frame: eigth weeks

    Compare changes in phase angle (degrees), estimated by bioimpedance analysis before and after

Sponsors and collaborators

Lead sponsor

Carla Basualto Alarcón

Other

Registry information

Official study title

Effects of Creatine Supplementation in Sarcopenic and Non-sarcopenic Patients on Chronic Hemodialysis

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 24, 2025
Registry last updated
Jun 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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