NCT00974636

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Kidney Disease

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Low Salt Diet	Dietary sodium restriction of ≤2.0 g/day or ≤ 85 mmol/day
DIETARY_SUPPLEMENT	Usual Salt Diet	Usual salt intake (approximately \>180-200 mmol/day in the average American diet).

Timeline

• Start date: 2009-05-01
• Primary completion: 2013-02-01
• Completion: 2013-05-01
• First posted: 2009-09-10
• Last updated: 2015-08-05

Locations

1 site across 1 country: United States