Clinical Trial: Sodium Lowering and Urinary Protein Reduction Trial
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: Effect of Dietary Sodium Reduction in Kidney Disease Patients With Albuminuria
Brief Summary: The proposed randomized controlled trial will test the effect of dietary sodium reduction on albuminuria in patients with proteinuric chronic kidney disease. Results from this study will clarify the role of dietary sodium reduction in management of patients with proteinuric chronic kidney disease and its potential to halt the progression of chronic kidney disease.
Detailed Summary: Proteinuria is an early and sensitive marker of kidney damage and a risk factor for chronic kidney disease (CKD) progression, cardiovascular disease and all-cause mortality. Several cross-sectional epidemiological studies have reported an association between sodium intake and albuminuria (majority of proteinuria) that is independent of blood pressure (BP). In addition, a handful of small clinical trials have suggested a reduction in dietary sodium intake may decrease albuminuria in patients with CKD. The overall goal of this randomized controlled trial is to study the effect of dietary sodium reduction on albuminuria in CKD patients with albuminuria. A total of 150 participants with CKD and albuminuria will be recruited and randomly assigned to either a 24-week intensive behavioral modification program designed to reduce dietary sodium intake to 2,300 mg/day or to usual care in a 1:1 randomization ratio. The primary outcome will be the difference between the active intervention and control groups for change in urinary albumin-to-creatinine ratio from baseline to 24 weeks of follow-up. Urinary albumin-to-creatinine ratio will be assessed as the average of two 24-hour urine collections at each time point. Secondary outcomes will include estimated glomerular filtration rate (eGFR), BP, and number of antihypertensive medications. Urinary sodium excretion will be used to measure the success of the intervention. Racial differences in albuminuria changes due to reduction in dietary sodium intake will be analyzed. The intervention program will be modeled on best practices derived from the investigators prior experience in conducting sodium reduction behavioral interventions. The intervention program will address individual barriers to long-term sodium reduction and generate collective enthusiasm and motivation for adherence to the program. Study staff will receive training and direct support from a consultant with extensive experience in successful implementation of behavio
Sponsor: Tulane University School of Public Health and Tropical Medicine
Current Primary Outcome: Net Change in Urinary Albumin-to-Creatinine Ratio (ACR) [ Time Frame: Assessed twice at baseline, once at week 12, and twice at week 24 ]
Original Primary Outcome: Net Change in Urinary Albumin-to-Creatinine Ratio (ACR) [ Time Frame: Assessed twice at baseline, once at week 12, and twice at week 24 ]
Current Secondary Outcome:
- Net Change in Urinary Albumin [ Time Frame: Assessed twice at baseline, once at week 12, and twice at week 24 ]
- Estimated Glomerular Filtration Rate (eGFR) [ Time Frame: Assessed at baseline, week 12, and week 24 ]
- Blood Pressure [ Time Frame: Assessed twice at baseline, once at week 12, and twice at week 24 ]
- Number of Antihypertensive Medications [ Time Frame: Assessed at baseline, week 12, and week 24 ]
Original Secondary Outcome:
- Net Change in Urinary Albumin [ Time Frame: Assessed twice at baseline, once at week 12, and twice at week 24 ]The difference between the dietary sodium reduction intervention group and the usual care group for change in urinary albumin during the 24-week study period is a secondary outcome.
- Estimated Glomerular Filtration Rate [ Time Frame: Assessed at baseline, week 12, and week 24 ]The difference between the dietary sodium reduction intervention group and the usual care group for change in estimated glomerular filtration rate during the 24-week study period is a secondary outcome.
- Blood Pressure [ Time Frame: Assessed twice at baseline, once at week 12, and twice at week 24 ]The difference between the dietary sodium reduction intervention group and the usual care group for change systolic and diastolic blood pressure during the 24-week study period is a secondary outcome.
- Number of Antihypertensive Medications [ Time Frame: Assessed at baseline, week 12, and week 24 ]The difference between the dietary sodium reduction intervention group and the usual care group for change in number of antihypertensive medications during the 24-week study period is a secondary outcome.
Information By: Tulane University
Dates:
Date Received: October 25, 2016
Date Started: November 2016
Date Completion: November 2018
Last Updated: November 30, 2016
Last Verified: November 2016
