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Dietary Supplement

Potassium-Containing Salt Substitute for Kidney Failure

N/A

Waitlist Available

Led By David Charytan, MD MSc

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 21 years.

Receiving outpatient maintenance HD therapy.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 36, day 52

Awards & highlights

Study Summary

This trial will test the effects of a potassium-containing salt-substitute on individuals with hemodialysis-dependent end stage kidney disease.

Who is the study for?

This trial is for adults over 21 with end-stage kidney disease who are on outpatient hemodialysis. They must not be pregnant, incarcerated, unable to consent, have high potassium levels or missed too many dialysis sessions recently. People living with someone who has severe kidney issues or uses potassium supplements can't join.Check my eligibility

What is being tested?

The study tests a potassium-containing salt substitute versus standard table salt in patients undergoing hemodialysis. Each participant will try both salts for 16 days each, separated by a 19-day break. The main focus is how the different salts affect blood potassium levels.See study design

What are the potential side effects?

Potential side effects may include changes in blood pressure and peri-dialytic symptoms like muscle cramps or low blood pressure due to shifts in electrolyte balance from varying dietary sodium and potassium intake.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 21 years old or older.

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I am currently on outpatient hemodialysis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 36, day 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 36, day 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 36, day 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Serum Potassium Concentration During First Treatment Period

Change in Serum Potassium Concentration During Second Treatment Period

Secondary outcome measures

Change in Ambulatory Systolic Blood Pressure During First Treatment Period

Change in Ambulatory Systolic Blood Pressure During Second Treatment Period

Mean Potassium Concentration During First Treatment Period

+7 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Standard Table Salt, then Salt SubstituteExperimental Treatment2 Interventions

The two intervention periods will last 16 days with a 19-day washout period in between. During the first 16-day treatment period, participants will receive the Standard Table Salt to use for cooking and as an additive at the table. Participants will then undergo a 19-day washout period. The second 16-day treatment period will immediately follow the washout period. During the second 16-day treatment period, participants will receive the Salt Substitute to use for cooking and as an additive at the table. Participants will be encouraged to replace their use of regular salt with the Standard Table Salt and Salt Substitute. They will be encouraged to reduce their overall intake of salt throughout the study period. There are no restrictions or further instructions regarding timing or dosing. In addition, participants will undergo standard of care hemodialysis (typically 3x/week) and have their blood chemistries measured according to the usual standard of care during the study.

Group II: Salt Substitute, then Standard Table SaltExperimental Treatment2 Interventions

The two intervention periods will last 16 days with a 19-day washout period in between. During the first 16-day treatment period, participants will receive the Salt Substitute to use for cooking and as an additive at the table. Participants will then undergo a 19-day washout period. The second 16-day treatment period will immediately follow the washout period. During the second 16-day treatment period, participants will receive the Standard Table Salt to use for cooking and as an additive at the table. Participants will be encouraged to replace their use of regular salt with the Standard Table Salt and Salt Substitute. They will be encouraged to reduce their overall intake of salt throughout the study period. There are no restrictions or further instructions regarding timing or dosing. In addition, participants will undergo standard of care hemodialysis (typically 3x/week) and have their blood chemistries measured according to the usual standard of care during the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Salt Substitute

2009

N/A

~290

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor

1,367 Previous Clinical Trials

839,701 Total Patients Enrolled

David Charytan, MD MScPrincipal InvestigatorNYU Langone Medical Center

Media Library

Potassium Containing Salt-Substitute (Dietary Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT05558267 — N/A

Kidney Failure Research Study Groups: Salt Substitute, then Standard Table Salt, Standard Table Salt, then Salt Substitute

Kidney Failure Clinical Trial 2023: Potassium Containing Salt-Substitute Highlights & Side Effects. Trial Name: NCT05558267 — N/A

Potassium Containing Salt-Substitute (Dietary Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05558267 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the hoped-for effects from this clinical trial?

"The primary measurement of efficacy in this trial, evaluated from Day 1 to Day 36 and then again from Day 52 will be the alterations in serum potassium levels. Secondary objectives include assessing mean pre-dialysis systolic blood pressure during both treatment periods (spanning Days 1 - 16 and again on Days 36 - 52), as well as average potassium concentration over the first span of time."

Answered by AI

Is this trial recruiting participants currently?

"As per the information on clinicaltrials.gov, this research project is not currently open for enrollment. This trial was first advertised on November 15th 2022 and recently updated in September 23rd of that same year. Despite its closure at present, 587 other studies are actively recruiting patients right now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Potassium Containing Salt-Substitute in Hemodialysis-Dependent End Stage Kidney Disease

2024. "Potassium Containing Salt-Substitute in Hemodialysis-Dependent End Stage Kidney Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05558267.

All > Dialysis