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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.

Must not have

Insufficient capacity for informed consent.

Co-habiting family with ≥stage 3b chronic kidney disease or chronic kidney disease of unknown severity.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 36, day 52

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am unable to understand and give informed consent.

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A family member I live with has advanced chronic kidney disease.

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I am currently taking potassium supplements.

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I have missed more than 3 of my last 13 outpatient hemodialysis sessions.

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A family member I live with has high potassium levels.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Serum Potassium Concentration During First Treatment Period

Change in Serum Potassium Concentration During Second Treatment Period

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 7Eligibility criteria met