Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

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

This study has been completed.
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
Sharon Turban, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00949585
First received: July 29, 2009
Last updated: September 18, 2012
Last verified: September 2012
History of Changes
  Purpose

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 Intervention
Chronic Kidney Disease
Hypertension
 Other: Dietary intake of potassium

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Potassium Intake in Patients With Chronic Kidney Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • 24-hour ambulatory systolic blood pressure [ Time Frame: At screening, and at the end (4th week) of each intervention period ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • Serum potassium [ Time Frame: At screening, run-in, and at least 3 times during each intervention period ] [ Designated as safety issue: Yes ]
Enrollment: 29
Study Start Date: July 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00949585

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

No publications provided

Responsible Party: Sharon Turban, Assistant Professor of Medicine, Division of Nephrology, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00949585     History of Changes
Other Study ID Numbers: AHA 0835162N
Study First Received: July 29, 2009
Last Updated: September 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
randomized, controlled feeding study;
crossover design
potassium intake

Additional relevant MeSH terms:
Hypertension
Kidney Diseases
Renal Insufficiency, Chronic
Cardiovascular Diseases
 Renal Insufficiency
Urologic Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on February 26, 2015