Dietary Sodium Intake and Blood Pressure in Living Kidney Donors

NCT05041829 | Suspended DMC

• 1 other identifier: 20216478
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot study to determine the feasibility of the study design and examine the main outcome whether low dietary sodium intake is superior to high dietary sodium intake in controlling blood pressure to be within the normotensive range in living kidney donors.

Conditions

Hypertension; Living Kidney Donor; Dietary Sodium Intake

Keywords

Living kidney donor; High blood pressure; Salt intake; Clinical trial

Outcome Measures

Primary Outcomes (1)

• Change in systolic and diastolic blood pressure from baseline to post-treatment between the two treatment groups

  Change in systolic and diastolic blood pressure from baseline to post-treatment between the two treatment groups, adjusting for patients' demographic and clinical differences (age, gender, BMI, and comorbidities) between the two treatment groups

  4 weeks after dietary intervention pre-crossover and 4 weeks after dietary intervention post-crossover

Secondary Outcomes (4)

• Hypertension

  4 weeks after dietary intervention pre-crossover and 4 weeks after dietary intervention post-crossover

• Worsening kidney function

  4 weeks after dietary intervention pre-crossover and 4 weeks after dietary intervention post-crossover

• Worsening proteinuria

  4 weeks after dietary intervention pre-crossover and 4 weeks after dietary intervention post-crossover

• Proteinuria

  4 weeks after dietary intervention pre-crossover and 4 weeks after dietary intervention post-crossover

Study Arms (2)

lowsodium

EXPERIMENTAL

Participants in this arm will be guided to have low dietary sodium intake of \<2.3 g/day (\<100 mmol/day) for 4 weeks.

Other: Dietary sodium

highsodium

ACTIVE COMPARATOR

Participants in this arm will be guided to have low dietary sodium intake of ≥4 - \<6 g/day (≥174 - \<261 mmo/day) for 4 weeks.

Other: Dietary sodium

Interventions

Dietary sodium OTHER

Low sodium diet with sodium of \<2.3 g/day (\<100 mmol/day) and high sodium diet with sodium of ≥4 - \<6 g/day (≥174 - \<261 mmo/day)

highsodium; lowsodium

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Living kidney donors who underwent a living kidney donation at least 5 months ago but not more than 12 months
• Age ≥18 years old
• Agree to perform the procedure as per study protocol (Table 1)
• Living kidney donors with an average sitting SBP \<160 mmHg at 5-month post-donation measured by automatic office blood pressure (AOBP)
• Able to sign informed consent
• Able to attend all research visits
• Woman using birth control methods other than hormonal contraception

You may not qualify if:

• History of previous cardiovascular (CV) events including acute MI, HF, and stroke
• Symptomatic heart failure within 5 months after living kidney donation or left ventricular ejection fraction (by any method) \<35%
• CV event or procedure or hospitalization for hypertensive-related disorders within 5 months after living kidney donation
• Diagnosed with HTN or on antihypertensive medication(s) before living kidney donation
• Patients who are supposed to take BP lowering medications for reasons other than BP control but do not take those medications or take them with in appropriate doses
• Arm circumference is too small or large to allow accurate BP measurement with available 24-h ABPM machines.
• An average standing SBP ≥160 mmHg at 5-month post-donation measured by automatic office blood pressure (AOBP)
• Albuminuria that equals or is equivalent to 1 g per day by using spot urinary albumin per urine creatinine ratio (UACR) or 24-hour urinary albumin excretion rate by a 24-hour urine collection within 5 months post-donation
• Advanced kidney function defined by estimated glomerular filtration rate (eGFR) by using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation22 of \<20 ml/min/1.73m2 or requiring dialysis after living kidney donation
• Drink coffee \> two 8-ounce (237 mL) cup a day or equivalence
• Drinks alcohol \>3 drinks/day or \>30 ml/day
• Smoking cigarette ≥10 cigarettes/day
• Take Nonsteroidal anti-inflammatory drugs (NSAIDS)
• Use hormone replacement therapy or oral contraceptives
• Pregnancy, currently trying to become pregnant

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

University of California Irvine Medical Center

Orange, California, 92868, United States

Location

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  RESULT

MeSH Terms

Conditions

Hypertension

Interventions

Sodium, Dietary

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Sodium Compounds; Inorganic Chemicals

Study Officials

• Ekamol Tantisattamo, MD, MPH

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Investigator will be masked for assigned amount of dietary sodium intake of participants.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Clinical Professor of Medicine

Model Details: There are two 4-week experimental periods, each participant will received low and high sodium diet during one of the periods and the order of the amount of sodium diet will be determined by randomization.

Study Record Dates

• First Submitted: September 3, 2021
• First Posted: September 13, 2021
• Study Start: November 3, 2021
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: August 21, 2025

Record last verified: 2025-08

Locations

US (1)