N/A N=31 Randomized Treatment

Diet and Hypertension Management in African Americans With Chronic Kidney Disease

Chronic Kidney Diseases · High Blood Pressure

Bottom Line

View on ClinicalTrials.gov: NCT04084574 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2025

Primary outcome: Primary: Number of Group Counseling Sessions Attended by Participants Randomized to the Treatment Arm — 8.9 sessions per participant

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: DASH diet counseling (Behavioral)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: Duke University
Primary completion: Aug 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Group Counseling Sessions Attended by Participants Randomized to the Treatment Arm	8.9	—
PRIMARY Number of Participants Who Completed Data Collection Visits at Scheduled Study Timepoints	16; 15; 14; 15; 14; 14	—
PRIMARY Change in 24-hour Mean Systolic Blood Pressure	-0.9; 4.0	0.3968
PRIMARY Change in Serum Potassium Concentration	0.06; 0.01	0.07926
PRIMARY Change in 24 Hour Urine Sodium Concentration	-8.2; -19.9	0.0673
PRIMARY Change in 24 Hour Urine Phosphorus Concentration	-73.0; -62.3	0.8821
PRIMARY Change in 24 Hour Urine Urea Nitrogen Concentration	-0.5; -1.07	0.6479
SECONDARY Change in Clinic Mean Systolic Blood Pressure	4.6; -2.4	0.4044
SECONDARY Change in Body Weight	0.16; -1.18	0.2374
SECONDARY Change in Mean Clinic Systolic Blood Pressure From 12 Weeks (End of Treatment) to 24 Week Observation	-7.9; -5.2	0.6188
SECONDARY Change in Body Weight From 12 Weeks (End of Treatment) to 24 Week Observation	-0.77; 0.62	0.0546
SECONDARY Change in DASH Diet Score From 12 Weeks (End of Treatment) to 24 Week Observation	0.25; 0.25	1.00
SECONDARY Change in DASH Diet Score From Baseline to 12 Weeks (End of Treatment)	0.15; -0.14	1.00

Summary

The purpose of this study is to determine cultural and disease-related barriers and facilitators to following the Dietary Approaches to Stop Hypertension (DASH) dietary pattern among Black Americans with moderate chronic kidney disease (CKD) and test the impact of a behavioral diet counseling intervention on DASH diet adherence, blood pressure, and CKD-relevant outcomes.

Eligibility Criteria

Inclusion Criteria

Black race (self-identified)
≥21 years old
CKD defined as an eGFR of 30-59 ml/min/1.73m2

Exclusion Criteria

History of kidney transplant
Pregnant of breast-feeding
Risk factors for hyperkalemia including insulin-dependent diabetes mellitus, diabetes with poor blood glucose control (A1C >10), baseline serum potassium ≥4.8 mg/dl, and serum bicarbonate <18 mg/dl
History of hypertension in the preceding 6 months defined as serum potassium greater than 5.1 mg/dl
Risk for hypotension or severe hypertension (SBP <120 or ≥180 or DBP ≥110 mmHg)
History of kidney transplant
Lack of English language proficiency

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04084574). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.