Status:
COMPLETED
Lowering Salt Intake in Chronic Kidney Disease: A Pilot Randomized Crossover Trial
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
Renal Research Institute
Conditions:
Kidney Disease
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
ABSTRACT Background: It is well recognized that excess dietary salt intake plays a major role in the development of hypertension. Chronic Kidney Disease (CKD) is associated with excess salt and wate...
Eligibility Criteria
Inclusion
- Individuals eligible to participate in this study must meet all of the following criteria:
- Willing and able to provide written, signed informed consent after the nature of the study has been explained, and prior to any research-related procedures.
- Age ≥ 18 years and ≤ 85 years.
- Willing and able to comply with all study procedures.
- Patients with eGFR of 20 to 60 ml/min/173m2 by the abbreviated (4-variable) MDRD equation and a relatively stable clinical course.
- Sitting systolic blood pressure ≥ 100 mmHg prior to study entry (to exclude people at risk from hypotension from dietary salt reduction).
Exclusion
- Individuals who meet any of the following exclusion criteria will not be eligible to participate in the study:
- Recent acute illness (≤1 month). Minor ailments such as a recovered common cold or allergic rhinitis would not be considered as exclusion criteria but would be left to the site PI's discretion.
- Recent hospitalization (≤1 month) unless clearly for a minor elective procedure unlikely to interfere with BIA measurements. The final decision will be left to the site PI's discretion.
- Any psychological condition (including alcoholism) that could interfere with the patient's ability to comply with the study protocol.
- Subjects with baseline 24-hour urinary sodium excretion ≤100 mmol/day.
- Amputation of a limb other than fingers or toes.
- Pacemaker, defibrillator, implantable pump, artificial joint, pins, plates or other types of metal objects in the body (other than dental fillings).
- Coronary stents or metal suture material in the heart.
- Use of any investigational product or investigational medical device within 30 days prior to screening, or requirement for any investigational agent prior to completion of all scheduled study assessments.
- Weight over 300 pounds (limitation for examination table).
- Pregnancy or lactation.
- Patients with kidney diseases known to be associated with salt wasting (see above).
- Patients with atrial fibrillation as ambulatory blood pressure measurements may not be accurate in this setting.
- Any condition that, in the view of the PI, places the subject at high risk of poor treatment compliance or of not completing the study.
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00974636
Start Date
May 1 2009
End Date
May 1 2013
Last Update
August 5 2015
Active Locations (1)
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1
University of North Carolina
Chapel Hill, North Carolina, United States, 27599