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

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

Tracking Information
First Submitted Date  ICMJE July 29, 2009
First Posted Date  ICMJE July 30, 2009
Last Update Posted Date September 19, 2012
Study Start Date  ICMJE July 2009
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 18, 2012)
24-hour ambulatory systolic blood pressure [ Time Frame: At screening, and at the end (4th week) of each intervention period ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 29, 2009)
24-hour ambulatory systolic blood pressure [ Time Frame: At screening, and at the end of each intervention period ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 18, 2012)
  • 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 ]
  • 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 ]
  • Serum potassium [ Time Frame: At screening, run-in, and at least 3 times during each intervention period ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 29, 2009)
  • 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 ]
  • measures of central blood pressure (pulse wave velocity and augmentation index) [ Time Frame: at screening and at the end of each intervention period ]
  • Serum potassium [ Time Frame: At screening, run-in, and at least 3 times during each intervention period ]
  • Serum inflammatory markers [ Time Frame: Before and and the end of each intervention period ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Potassium Intake in Patients With Chronic Kidney Disease
Official Title  ICMJE Potassium Intake in Patients With Chronic Kidney Disease
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
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Kidney Disease
  • Hypertension
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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
    Intervention: Other: Dietary intake of potassium
  • Dietary potassium intake: 40 mmol/day
    Diet containing 40 mmol/day of potassium
    Intervention: Other: Dietary intake of potassium
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 18, 2012)
29
Original Estimated Enrollment  ICMJE
 (submitted: July 29, 2009)
26
Actual Study Completion Date  ICMJE June 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00949585
Other Study ID Numbers  ICMJE AHA 0835162N
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sharon Turban, Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE American Heart Association
Investigators  ICMJE
Principal Investigator: Sharon Turban, MD, MHS Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP