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Lowering Salt Intake in Chronic Kidney Disease: A Pilot Randomized Crossover Trial (BIA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00974636
Recruitment Status : Completed
First Posted : September 10, 2009
Last Update Posted : August 5, 2015
Sponsor:
Collaborator:
Renal Research Institute
Information provided by (Responsible Party):
Rajiv Saran, University of Michigan

Tracking Information
First Submitted Date  ICMJE September 9, 2009
First Posted Date  ICMJE September 10, 2009
Last Update Posted Date August 5, 2015
Study Start Date  ICMJE May 2009
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 9, 2009)
Primary Outcome: Change in volume status (intracellular, extracellular volume, and total body water) as measured by BIA using both whole body and segmental techniques [ Time Frame: 12 Weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lowering Salt Intake in Chronic Kidney Disease: A Pilot Randomized Crossover Trial
Official Title  ICMJE Lowering Salt Intake in Chronic Kidney Disease: A Pilot Randomized Crossover Trial
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 water retention (excess volume) which is associated with hypertension.

Hypotheses:

Hypothesis 1:

Dietary salt restriction will improve volume status in subjects with CKD stages 3-4 as assessed by Bioelectrical Impedance Analysis (BIA).

Hypothesis 2:

Dietary salt restriction will result in improved blood pressure control in patients with CKD stages 3-4.

Hypothesis 3:

Dietary salt restriction will decrease albuminuria in patients with CKD stages 3-4.

Patients and Trial Design: This randomized crossover pilot study is designed to assess the effect of salt restriction on volume status in patients with CKD stages 3 and 4.

Subjects will be randomized to a treatment order: (1) 4 weeks of salt restriction of <85 mmol sodium per day, a 2 week washout period, and 4 weeks of usual salt diet, OR (2) 4 weeks of usual diet, 2 weeks washout, and 4 weeks of salt restriction. Patients will receive dietary counseling in person at each study visit and at weekly intervals by phone calls from study dieticians. At weeks 0, 4, 6 and 10, patients will undergo assessments for (i) physical examination with assessments for weight, blood pressure, pulse, anthropometrics and a standardized clinical assessment of volume status. (ii) volume status using bioelectrical impedance analysis (BIA) (iii) 24-hour urine testing for, albumin, creatinine and aldosterone Every 2 weeks throughout the study, a 24-hour urine sodium will be measured for compliance, and serum electrolytes will be assessed for safety.

Data Analysis: BIA measurements in the low salt group will be compared with the regular diet group using the standard linear model analysis for 2x2 crossover trials. Additionally, 24-hour ambulatory and static blood pressure and 24-hour urine aldosterone levels will be compared between the two groups.

Future Implications: A significant reduction in the degree of volume expansion (as assessed by BIA) and blood pressure as a result of a salt restricted diet would have implications for renal and cardiovascular protection and would warrant confirmation by a larger randomized trial.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Condition  ICMJE Kidney Disease
Intervention  ICMJE
  • Dietary Supplement: Low Salt Diet
    Dietary sodium restriction of ≤2.0 g/day or ≤ 85 mmol/day
    Other Name: Low salt diet, CKD, Bioimpedance analysis (BIA)
  • Dietary Supplement: Usual Salt Diet
    Usual salt intake (approximately >180-200 mmol/day in the average American diet).
Study Arms  ICMJE
  • Experimental: Low Salt Diet
    Dietary sodium restriction of ≤2.0 g/day or ≤ 85 mmol/day for two weeks
    Intervention: Dietary Supplement: Low Salt Diet
  • Placebo Comparator: Ususal Salt Diet
    Usual salt intake (approximately >180-200 mmol/day in the average American diet).
    Intervention: Dietary Supplement: Usual Salt Diet
Publications * McMahon EJ, Campbell KL, Bauer JD, Mudge DW, Kelly JT. Altered dietary salt intake for people with chronic kidney disease. Cochrane Database Syst Rev. 2021 Jun 24;6:CD010070. doi: 10.1002/14651858.CD010070.pub3.

*   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: January 7, 2013)
35
Original Estimated Enrollment  ICMJE
 (submitted: September 9, 2009)
75
Actual Study Completion Date  ICMJE May 2013
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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 Criteria:

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (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 NCT00974636
Other Study ID Numbers  ICMJE HUM00016384
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rajiv Saran, University of Michigan
Study Sponsor  ICMJE University of Michigan
Collaborators  ICMJE Renal Research Institute
Investigators  ICMJE
Principal Investigator: Rajiv Saran, MD University of Michigan
PRS Account University of Michigan
Verification Date August 2015

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