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

Primary Purpose

Chronic Kidney Disease, Hypertension

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dietary intake of potassium
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring randomized, controlled feeding study;, crossover design, potassium intake

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Johns Hopkins University Pro Health Clinical Research Facility

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Dietary potassium intake: 100 mmol/day

Dietary potassium intake: 40 mmol/day

Arm Description

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

Diet containing 40 mmol/day of potassium

Outcomes

Primary Outcome Measures

24-hour ambulatory systolic blood pressure

Secondary Outcome Measures

other measures of peripheral blood pressure (other types of ambulatory blood pressure measurements as well as clinic blood pressure)
measures of central blood pressure (pulse wave velocity and augmentation index)
Serum potassium

Full Information

First Posted
July 29, 2009
Last Updated
September 18, 2012
Sponsor
Johns Hopkins University
Collaborators
American Heart Association
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1. Study Identification

Unique Protocol Identification Number
NCT00949585
Brief Title
Potassium Intake in Patients With Chronic Kidney Disease
Acronym
CKD-K
Official Title
Potassium Intake in Patients With Chronic Kidney Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johns Hopkins University
Collaborators
American Heart Association

4. Oversight

Data Monitoring Committee
Yes

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Hypertension
Keywords
randomized, controlled feeding study;, crossover design, potassium intake

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dietary potassium intake: 100 mmol/day
Arm Type
Other
Arm Description
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
Arm Title
Dietary potassium intake: 40 mmol/day
Arm Type
Other
Arm Description
Diet containing 40 mmol/day of potassium
Intervention Type
Other
Intervention Name(s)
Dietary intake of potassium
Intervention Description
Comparison of two diets: one contains 100 mmol potassium per day, and the other contains 40 mmol potassium per day
Primary Outcome Measure Information:
Title
24-hour ambulatory systolic blood pressure
Time Frame
At screening, and at the end (4th week) of each intervention period
Secondary Outcome Measure Information:
Title
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
Title
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
Title
Serum potassium
Time Frame
At screening, run-in, and at least 3 times during each intervention period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon Turban, MD, MHS
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University Pro Health Clinical Research Facility
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21207
Country
United States

12. IPD Sharing Statement

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Potassium Intake in Patients With Chronic Kidney Disease

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