Sodium Lowering and Urinary Protein Reduction Trial (SUPER)
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|ClinicalTrials.gov Identifier: NCT02945969|
Recruitment Status : Completed
First Posted : October 26, 2016
Last Update Posted : March 9, 2021
|Condition or disease||Intervention/treatment||Phase|
|Chronic Kidney Disease Albuminuria||Behavioral: Low Sodium Diet||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||151 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Dietary Sodium Reduction in Kidney Disease Patients With Albuminuria|
|Study Start Date :||November 2016|
|Actual Primary Completion Date :||January 2021|
|Actual Study Completion Date :||January 2021|
Experimental: 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.
Behavioral: 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.
No Intervention: Usual Diet
No dietary intervention.
- Net Change in Urinary Albumin-to-Creatinine Ratio (ACR) [ Time Frame: Assessed twice at baseline, once at week 12, and twice at week 24 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02945969
|United States, Louisiana|
|New Orleans, Louisiana, United States, 70112|
|Principal Investigator:||Katherine T Mills, PhD, MSPH||Tulane University School of Public Health and Tropical Medicine|