Sodium Lowering and Urinary Protein Reduction Trial

NCT ID: NCT02945969

Last Updated: 2022-12-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 151 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2021-01-31

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.

Conditions

Chronic Kidney Disease; Albuminuria

Keywords

dietary sodium; albuminuria; chronic kidney disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Low Sodium Diet

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.

Group Type: EXPERIMENTAL

Low Sodium Diet

Intervention Type: BEHAVIORAL

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.

Usual Diet

No dietary intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Low Sodium Diet

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tulane University School of Public Health and Tropical Medicine

OTHER

Sponsor Role: lead

Responsible Party

Katherine T Mills

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Katherine T Mills, PhD, MSPH

Role: PRINCIPAL_INVESTIGATOR

Tulane University School of Public Health and Tropical Medicine

Locations

Tulane University

New Orleans, Louisiana, United States

Countries

United States

References

McMahon EJ, Campbell KL, Bauer JD, Mudge DW, Kelly JT. Altered dietary salt intake for people with chronic kidney disease. Cochrane Database Syst Rev. 2021 Jun 24;6(6):CD010070. doi: 10.1002/14651858.CD010070.pub3.

Reference Type: DERIVED

PMID: 34164803 (View on PubMed)

Other Identifiers

1P20GM109036

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1P20GM109036-P1

Identifier Type: -

Identifier Source: org_study_id