Potassium Intake in Patients With Chronic Kidney Disease

NCT00949585 | Completed DMC

• 1 other identifier: AHA 0835162N
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Kidney Disease; Hypertension

Keywords

randomized, controlled feeding study;; crossover design; potassium intake

Outcome Measures

Primary Outcomes (1)

• 24-hour ambulatory systolic blood pressure

  At screening, and at the end (4th week) of each intervention period

Secondary Outcomes (3)

• other measures of peripheral blood pressure (other types of ambulatory blood pressure measurements as well as clinic blood pressure)

  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)

  at screening and at the end (4th week) of each intervention period

• Serum potassium

  At screening, run-in, and at least 3 times during each intervention period

Study Arms (2)

Dietary potassium intake: 100 mmol/day

OTHER

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

Dietary potassium intake: 40 mmol/day

OTHER

Diet containing 40 mmol/day of potassium

Other: Dietary intake of potassium

Interventions

Dietary intake of potassium OTHER

Comparison of two diets: one contains 100 mmol potassium per day, and the other contains 40 mmol potassium per day

Dietary potassium intake: 100 mmol/day; Dietary potassium intake: 40 mmol/day

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• American Heart Association: collaborator

Study Sites (1)

Johns Hopkins University Pro Health Clinical Research Facility

Baltimore, Maryland, 21207, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hypertension

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Sharon Turban, MD, MHS

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine, Division of Nephrology

Study Record Dates

• First Submitted: July 29, 2009
• First Posted: July 30, 2009
• Study Start: July 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: September 19, 2012

Record last verified: 2012-09

Locations

US (1)