Effects of Short Term Creatine Supplementation in Hemodialysis Patients

NCT ID: NCT07033611

Last Updated: 2025-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2024-02-28

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.

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.

Conditions

Dialysis; Complications; Performance Enhancing Product Use

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pre creatine and post

patients before and after creatine suplemmentation

Group Type: EXPERIMENTAL

Creatine

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Creatine

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Carla Basualto Alarcón

OTHER

Sponsor Role: lead

Responsible Party

Carla Basualto Alarcón

Associate Professor, U Aysen. MD., MSc., PhD.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Carla Basualto-Alarcón, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad de Aysén

Locations

Hospital de Puerto Aysen

Puerto Aisén, Región de Aysen, Chile

Countries

Chile

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Other Identifiers

ORD252023

Identifier Type: -

Identifier Source: org_study_id