Intradialytic Creatine Supplementation

NCT05148208 | Unknown DMC

• 1 other identifier: 202100665
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief Summary

We perform a pilot study to investigate whether intra-dialytic creatine supplementation via the dialysate will result in higher intra-erythrocyte creatine concentrations. Secondary outcomes will include changes in muscle mass, muscle strength and cognition.

Conditions

Dialysis; Complications

Outcome Measures

Primary Outcomes (1)

• Intra-erythrocyte creatine concentration

  Intra-erythrocyte creatine concentration assessed by liquid chromatography mass spectrometry

  6 weeks

Study Arms (5)

Placebo

PLACEBO COMPARATOR

Supplementation of water

Device: Creatine supplementation to dialysate

Creatine 0.5 mM

ACTIVE COMPARATOR

Supplementation of creatine dissolved in water to a final concentration of 0.5 mM of creatine in the dialysate

Device: Creatine supplementation to dialysate

Creatine 1 mM

ACTIVE COMPARATOR

Supplementation of creatine dissolved in water to a final concentration of 1 mM of creatine in the dialysate

Device: Creatine supplementation to dialysate

Creatine 1.5 mM

ACTIVE COMPARATOR

Supplementation of creatine dissolved in water to a final concentration of 1.5 mM of creatine in the dialysate

Device: Creatine supplementation to dialysate

Creatine 2.0 mM

ACTIVE COMPARATOR

Supplementation of creatine dissolved in water to a final concentration of 2 mM of creatine in the dialysate

Device: Creatine supplementation to dialysate

Interventions

Creatine supplementation to dialysate DEVICE

Creatine supplementation to dialysate

Creatine 0.5 mM; Creatine 1 mM; Creatine 1.5 mM; Creatine 2.0 mM; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years;
• Hemodialysis treatment in the UMCG or DCG;
• Dialysis vintage ≥2 months;
• Conventional hemodialysis, thrice weekly treatment with three to five hours per dialysis treatment;
• Hemoglobin at previous routine monthly assessment greater than or equal to 6.5 mmol/l;
• Signed informed consent.

You may not qualify if:

• Pregnancy;
• Presence of clinical signs of infection;
• Confirmed diagnosis of malignancies;
• Incapacity of the Dutch language;
• Inability to complete questionnaires;
• Short life expectancy;
• Kidney transplantation planned within 3 months.

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2021
• First Posted: December 8, 2021
• Study Start: January 1, 2022
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: December 8, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share