Potassium Intake in Patients With Chronic Kidney Disease (CKD-K)

• ClinicalTrials.gov Identifier: NCT00949585
• Recruitment Status: Completed
• First Posted: July 30, 2009
• Last Update Posted: September 19, 2012
• Sponsor: Johns Hopkins University
• Collaborator: American Heart Association
• Information provided by (Responsible Party): Sharon Turban, Johns Hopkins University

Study Description

Brief Summary:

Chronic kidney disease is associated with high blood pressure, heart disease, and strokes. Potassium lowers blood pressure and may help prevent heart disease and strokes in the general population, but has not been well-studied in people with kidney disease. This study will look at the benefits and safety of two levels of potassium intake in patients with kidney disease. We expect that a higher level of potassium intake safely lowers blood pressure compared to a lower level of potassium intake. We hope that this and other research projects will help us to learn more so that guidelines can be created for potassium intake in patients with chronic kidney disease

Condition or disease	Intervention/treatment	Phase
Chronic Kidney Disease; Hypertension	Other: Dietary intake of potassium	Not Applicable

Detailed Description:

In individuals without chronic kidney disease (CKD), potassium (K) lowers blood pressure (BP) and may help prevent cardiovascular disease (CVD) and stroke. In animal models, K prevented kidney injury and decreased kidney inflammation. CKD patients may especially benefit from higher K intake, due to their high prevalence of hypertension, CVD, and stroke, and the possibility that K may retard CKD progression. Despite these potential benefits, there is great uncertainty about the optimal K intake in CKD patients. K is often restricted in these patients due to concerns about elevating serum K. However, renal K excretion does not appear to be substantially impaired until the glomerular filtration rate (GFR) is severely decreased (< 10-20 mL/min/1.73 m2). In this randomized feeding study with a two-period crossover design, the benefits and safety of 4 weeks of 100 mmol versus 40 mmol K/day in 26 non-diabetic adults with stage 3 CKD (estimated GFR 30-59 mL/min/1.73 m2) will be evaluated. After a one-week run-in period, all participants will be randomized to receive either a diet containing either 40 mmol K/day or 100 mmol K/day (within the current K/DOQI recommendations for K intake for stage 3 CKD) during period 1 (they will receive the other during period 2). The primary outcome variable is 24-hour ambulatory systolic BP. Secondary outcomes are other measures of peripheral BP, central BP, inflammatory markers, and serum K. We hope that this study will lead to a larger trial with sufficient power to examine the effects of increased K intake on clinical outcomes such as CKD progression. The ultimate goal of this effort is to develop the scientific basis for guidelines on K intake in CKD.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 29 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Potassium Intake in Patients With Chronic Kidney Disease
• Study Start Date: July 2009
• Actual Primary Completion Date: June 2011
• Actual Study Completion Date: June 2011

Arms and Interventions

Arm	Intervention/treatment
Dietary potassium intake: 100 mmol/day; Participants will be given one of two diets: one contains 100 mmol of potassium per day, and the other contains 40 mmol of potassium per day	Other: Dietary intake of potassium; Comparison of two diets: one contains 100 mmol potassium per day, and the other contains 40 mmol potassium per day
Dietary potassium intake: 40 mmol/day; Diet containing 40 mmol/day of potassium	Other: Dietary intake of potassium; Comparison of two diets: one contains 100 mmol potassium per day, and the other contains 40 mmol potassium per day

Outcome Measures

Primary Outcome Measures :

1. 24-hour ambulatory systolic blood pressure [ Time Frame: At screening, and at the end (4th week) of each intervention period ]

Secondary Outcome Measures :

1. other measures of peripheral blood pressure (other types of ambulatory blood pressure measurements as well as clinic blood pressure) [ Time Frame: Ambulatory BP: same as primary outcome. Clinic BP: at screening, run-in, and weekly during intervention ]
2. measures of central blood pressure (pulse wave velocity and augmentation index) [ Time Frame: at screening and at the end (4th week) of each intervention period ]
3. Serum potassium [ Time Frame: At screening, run-in, and at least 3 times during each intervention period ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Stage 3 chronic kidney disease (estimated glomerular filtration rate 30-59 mL/min/1.73 m2 by the 4-variable Modification of Diet in Renal Disease (MDRD) Study Equation
• Systolic blood pressure 120-159 mm Hg and diastolic blood pressure < 100 mm Hg
• Willingness to follow strict dietary rules for 9 weeks and to come to the clinical research unit at least 3 weekdays per week for one meal during the two study periods

Exclusion Criteria:

• Baseline serum potassium of at least 5.5 mEq/L
• Baseline serum potassium of less than 3.5 mEq/L
• Insulin-requiring or uncontrolled (HbA1C > 9 g/dL) diabetes mellitus
• Use of potassium supplements
• Use of digoxin
• Chronic disease(s) that may interfere with trial participation
• Pregnancy or lactation
• > 14 alcoholic drinks/week
• Major food allergies or intolerances

Contacts and Locations

Locations

United States, Maryland

Johns Hopkins University Pro Health Clinical Research Facility

Baltimore, Maryland, United States, 21207

Sponsors and Collaborators

Johns Hopkins University

American Heart Association

Investigators

• Principal Investigator: Sharon Turban, MD, MHS; Johns Hopkins University

More Information

• Responsible Party: Sharon Turban, Assistant Professor of Medicine, Division of Nephrology, Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT00949585
• Other Study ID Numbers: AHA 0835162N
• First Posted: July 30, 2009
• Last Update Posted: September 19, 2012
• Last Verified: September 2012

Keywords provided by Sharon Turban, Johns Hopkins University:

randomized, controlled feeding study; crossover design; potassium intake

Additional relevant MeSH terms:

Kidney Diseases; Renal Insufficiency, Chronic; Urologic Diseases; Renal Insufficiency