Status:
COMPLETED
Five, Plus Nuts and Beans for Kidneys
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
National Institute on Minority Health and Health Disparities (NIMHD)
Conditions:
Chronic Kidney Disease
Hypertension
Eligibility:
All Genders
21-100 years
Phase:
NA
Brief Summary
This Five, Plus Nuts and Beans for Kidneys Study is a single center, randomized controlled trial with 2 parallel arms testing the hypothesis that delivery of nutritional advice to adopt a Dietary Appr...
Detailed Description
This study will test the effectiveness of dietary advice delivered by a study coach and assistance with weekly online ordering of $30/week worth of potassium rich foods delivered by a local grocer to ...
Eligibility Criteria
Inclusion
- Self-identified African American race
- Age 21 years or older
- Clinical diagnosis of hypertension and have a urine Albumin-Creatinine Ratio (ACR) of ≥30 mg/g with or without estimated Glomerular Filtration Rate (GFR) 30-59 ml/min/1.73m2.
- Must be under regular care with their Johns Hopkins Community Physicians (JHCP) or Johns Hopkins Outpatient Center (JHOC) physician (seen within the past 12 months).
- Must have a systolic blood pressure of \<=160 mmHg and a diastolic blood pressure of \<=100 mmHg (average of two visits)
- Be on stable doses of antihypertensive medications for a minimum of two months prior to randomization.
Exclusion
- Cardiovascular (CV) event within 6 months
- Chronic disease that might interfere with trial participation (e.g. stage 4 or 5 Chronic Kidney Disease, Estimated Glomerular Filtration Rate \<30 ml/min/1.73m2)
- Unwillingness or inability to adopt a DASH-like diet
- Consumes over 14 alcoholic drinks per week
- Poorly controlled diabetes (Hemoglobin A1c \>9%).
- Patients with a serum potassium \>4.6 milliequivalent (mEq) /L45
- Urine ACR ≥ 1,000 mg/g
Key Trial Info
Start Date :
February 22 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 8 2021
Estimated Enrollment :
142 Patients enrolled
Trial Details
Trial ID
NCT03299816
Start Date
February 22 2018
End Date
December 8 2021
Last Update
June 22 2023
Active Locations (1)
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1
East Baltimore Medical Campus
Baltimore, Maryland, United States, 21202