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Recruiting NCT06487546

Repletion of Ergothioneine in Patients With Kidney Failure

No phase Interventional Esrd

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ergothioneine, Placebo.
Who it may be relevant to
Registry conditions: Esrd. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

Dialysis removes potentially harmful chemicals from the blood but can also remove potentially valuable chemicals. One potentially valuable chemical called ergothioneine, which comes from the diet, is low in the blood of people receiving dialysis. For this research study, the investigators hope to learn how well a daily ergothioneine supplement will replenish the levels in the blood of people with kidney failure.

Interventions

  • Dietary supplement Ergothioneine
    Participants will receive ergothioneine capsule daily for 12 weeks.
  • Other Placebo
    Participants will receive placebo capsule daily for 12 weeks.

Primary outcome measures

  • erythrocyte levels of ergothioneine [Time frame: weeks 1, 2, 4, 8, and 12 (while taking ergothioneine or placebo); and weeks 16 and 20 (after stopping ergothioneine or placebo)]
Secondary outcome measures (1)
  • plasma levels of ergothioneine [Time frame: weeks 1, 2, 4, 8, and 12 (while taking ergothioneine or placebo); and weeks 16 and 20 (after stopping ergothioneine or placebo)]

Eligibility criteria

Inclusion criteria

  • kidney failure receiving hemodialysis or peritoneal dialysis

Exclusion criteria

  • blood transfusion within 90 days
  • taking supplements which contain ergothioneine

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Other

Study locations

United States · 1 center
  • Veterans Affairs Palo Alto — Palo Alto

Publications

  • Halliwell B, Tang RMY, Cheah IK. Diet-Derived Antioxidants: The Special Case of Ergothioneine. Annu Rev Food Sci Technol. 2023 Mar 27;14:323-345. doi: 10.1146/annurev-food-060822-122236. Epub 2023 Jan 9. PMID 36623925
  • Chen L, Zhang L, Ye X, Deng Z, Zhao C. Ergothioneine and its congeners: anti-ageing mechanisms and pharmacophore biosynthesis. Protein Cell. 2024 Feb 29;15(3):191-206. doi: 10.1093/procel/pwad048. PMID 37561026

Identifiers

NCT: NCT06487546 · 75743

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗