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

Kidney Disease Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

• NCT number: NCT00974636
• Study type: Interventional
• Source: University of Michigan
• Status: Completed
• Phase: N/A
• Start date: May 2009
• Completion date: May 2013