Effect of Dietary Sodium Reduction in Kidney Disease Patients With Albuminuria

Sodium Lowering and Urinary Protein Reduction Trial

Sponsors

Lead sponsor: Tulane University School of Public Health and Tropical Medicine

Source Tulane University
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 Description

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 behavioral and dietary modification interventions. Results from this study will clarify the role of dietary sodium reduction in management of CKD patients with albuminuria and its potential to halt the progression of CKD, a global public health concern. The study will also explore the interaction of race/ethnicity with dietary sodium reduction on albuminuria in CKD patients.

Overall Status Recruiting
Start Date November 2016
Completion Date March 2020
Primary Completion Date March 2020
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Net Change in Urinary Albumin-to-Creatinine Ratio (ACR) Assessed twice at baseline, once at week 12, and twice at week 24
Secondary Outcome
Measure Time Frame
Net Change in Urinary Albumin Assessed twice at baseline, once at week 12, and twice at week 24
Estimated Glomerular Filtration Rate (eGFR) Assessed at baseline, week 12, and week 24
Blood Pressure Assessed twice at baseline, once at week 12, and twice at week 24
Number of Antihypertensive Medications Assessed at baseline, week 12, and week 24
Enrollment 150
Condition
Intervention

Intervention type: Behavioral

Intervention name: Low Sodium Diet

Description: Once randomized to the Intervention program, study participants will be grouped into intervention cohorts of approximately 10 participants per group to facilitate group counseling sessions. Both the intensive intervention phase and the maintenance phase will include individual and group behavioral modification counseling designed to facilitate a reduction in dietary sodium intake. Success of the intervention will be assessed by comparing the urine sodium measurements from 24-hour urine collections performed at screening, 12 weeks and 24 weeks.

Arm group label: Low Sodium Diet

Eligibility

Criteria:

Inclusion Criteria:

- Men or women at least 21 years of age: The lower age limit was chosen based on the National Institutes of Health (NIH) definition of adults for participation in research

- Any race or ethnicity: The investigators expect to recruit 50-60% African American and 40-50% non-African American (White, Hispanic, and Asian Americans), with the vast majority of the latter being non-Hispanic Whites.

- eGFR < 90 mL/min/1.73m2 but > 30 mL/min/1.73m2. The upper limit for eGFR was chosen to include participants with a clinically significant decrease in renal function. The investigators chose an upper eGFR limit slightly higher than the Kidney Disease Outcomes Quality Initiative (KDOQI) definition of moderately reduced glomerular filtration rate (GFR) to be more inclusive of patients with mild reduction in GFR but significant proteinuria. The lower eGFR limit was set to exclude patients with advanced CKD, where the potential effects of dietary sodium reduction on proteinuria may not be apparent or greatly alter CKD progression. The eGFR to define eligibility will be calculated using calibrated serum creatinine values and the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) estimating equation.

- Albumin-to-creatinine ratio > 30mg/g

Exclusion Criteria:

- Albuminuria ≥1.5 g/g or kidney structural change

- Prior kidney transplant based on self-report

- Immunosuppression or other immunotherapy within the past six months prior to enrollment based on patient self-report

- History of cancer other than non-melanoma skin cancer within two years prior to enrollment based on patient self-report

- History of polycystic kidney disease

- Currently receiving dialysis treatment

- History of human immunodeficiency virus (HIV)

- Current pregnancy, breastfeeding or plans to become pregnant during the study

- Consumption of ≥14 alcoholic drinks/week or consumption of ≥6 drinks/occasion

- Current participation in another lifestyle intervention trial

- Current residence or planned residence make it difficult to meet trial requirements

- Other concerns regarding ability to meet trial requirements, at the discretion of the principal investigator

Gender: All

Minimum age: 21 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Katherine T Mills, PhD, MSPH Principal Investigator Tulane University School of Public Health and Tropical Medicine
Overall Contact

Last name: Erin B Mahone, RN

Phone: 504-988-4361

Email: [email protected]

Location
facility status contact Tulane University Katherine T Mills, PhD 504-988-4749 [email protected]
Location Countries

United States

Verification Date

April 2019

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Tulane University School of Public Health and Tropical Medicine

Investigator full name: Katherine T Mills

Investigator title: Assistant Professor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Low Sodium Diet

Arm group type: Experimental

Description: Behavioral modification to decrease dietary sodium intake to ≤2,300 mg/day for 24 weeks. The intervention program consists of two phases. An initial 12-week intensive phase will include weekly individual and group sessions. This will be followed by a 12-week maintenance phase that includes telephone counseling sessions every 2 weeks.

Arm group label: Usual Diet

Arm group type: No Intervention

Description: No dietary intervention.

Acronym SUPER
Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Prevention

Masking: None (Open Label)

Source: ClinicalTrials.gov