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NCT00974636 · ClinicalTrials.gov registry record · NA
Lowering Salt Intake in Chronic Kidney Disease: A Pilot Randomized Crossover Trial
A NA study, sponsored by University of Michigan.
- Completed
- Registry status
- NA
- Development phase
- 35
- Enrollment target
NCT00974636 is a NA study that has completed, run by University of Michigan. The registered enrollment target is 35 participants.
The verdict
NCT00974636, a NA study, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- NA
- Development phase
- 35 participants
- Enrollment target
Study 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 gro
Interventions
- DIETARY_SUPPLEMENT Low Salt Diet
- DIETARY_SUPPLEMENT Usual Salt Diet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2009-05 |
| Est. Completion | 2013-05 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00974636
The ClinicalTrials.gov registry entry for NCT00974636 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan, which has 1,327 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Low Salt Diet is the first listed.
NCT00974636 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00974636 about?
NCT00974636 is a clinical study titled "Lowering Salt Intake in Chronic Kidney Disease: A Pilot Randomized Crossover Trial". 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: Diet...
What is the current status of trial NCT00974636?
This trial is currently completed. It is a NA study. The enrollment target is 35 participants. The study started on 2009-05. Estimated completion is 2013-05.
What interventions are being tested in trial NCT00974636?
The interventions under investigation include: Low Salt Diet (DIETARY_SUPPLEMENT), Usual Salt Diet (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT00974636?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
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