Lowering Salt Intake in Chronic Kidney Disease: A Pilot Randomized Crossover Trial
Public ClinicalTrials.gov record NCT00974636. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00974636
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 35 participants
Conditions and interventions
Conditions
Interventions
- Low Salt Diet Dietary Supplement
- Usual Salt Diet Dietary Supplement
Dietary Supplement
Eligibility (public fields only)
- Age range
- 18 Years to 85 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 30, 2009
- Primary completion
- Jan 31, 2013
- Completion
- Apr 30, 2013
- Last update posted
- Aug 4, 2015
2009 – 2013
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of North Carolina | Chapel Hill | North Carolina | 27599 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00974636, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 4, 2015 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00974636 live on ClinicalTrials.gov.