Dietary Sodium Intake and Blood Pressure in Living Kidney Donors (SPLID)

November 30, 2022 updated by: Ekamol Tantisattamo, MD, MPH, University of California, Irvine

Dietary Sodium Intake and Blood Pressure in Living Kidney Donors: A Pilot Single-Center Crossover Single-Blind Randomized Controlled Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a pilot study to determine the feasibility of the study design and examine the main outcome whether low dietary sodium intake <2.3 g/day (<100 mmol/day) is superior to high dietary sodium intake ≥4 - <6 g/day (≥174 - <261 mmo/day) in controlling blood pressure (BP) to be within normotensive range, lowering systolic and diastolic blood pressures (SBP and DBP) from the baseline blood pressures, and decreasing the risk of hypertension, worsening kidney function, and proteinuria in living kidney donors between 5 and 12 months after living kidney donation?.

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Orange, California, United States, 92868
        • Recruiting
        • University of California Irvine Medical Center
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Using birth control pills
  • A medical condition likely to limit survival to less than 2 years

  • Any factors that are likely to limit adherence to interventions. For example,

    • Living kidney donors who cannot come to follow up regularly per study protocol to logistically collect data from enrolled participants.
    • Active alcohol or substance abuse within the last 5 months of living kidney donation
    • Plans to move outside the clinic catchment area in the next 4 months without the ability to transfer to come to follow up at SPLID study site.
    • Significant history of poor adherences with medications or attendance at clinic visits
    • Significant concerns about participation in the study from spouse, significant other, or family members
    • Lack of support from primary health care provider
    • Residence too far from the study clinic site such that transportation is a barrier including persons who require transportation assistance provided by the SPLID clinic funds for screening or randomization visits
    • Residence in a nursing home or an assisted living
    • Clinical dementia with or without treatment with medications and cognitively unable to follow the protocol
    • Other medical, psychiatric, or behavioral factors that may interfere with study participation or the ability to follow the intervention protocol
    • Inability to obtain informed consent from participant
    • Living in the same household as an already randomized SPLID participant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: lowsodium
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
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)
Active Comparator: highsodium
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
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in systolic and diastolic blood pressure from baseline to post-treatment between the two treatment groups
Time Frame: 4 weeks after dietary intervention pre-crossover and 4 weeks after dietary intervention post-crossover
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hypertension
Time Frame: 4 weeks after dietary intervention pre-crossover and 4 weeks after dietary intervention post-crossover
New-onset hypertension defined as systolic blood pressure >/= 130 or diastolic blood pressure >/=80 mmHg
4 weeks after dietary intervention pre-crossover and 4 weeks after dietary intervention post-crossover
Worsening kidney function
Time Frame: 4 weeks after dietary intervention pre-crossover and 4 weeks after dietary intervention post-crossover
Increased estimated glomerular filtration rate (eGFR) >/= 25 ml/min/1.73 m2 or increased serum creatinine >/= 0.3 mg/dL
4 weeks after dietary intervention pre-crossover and 4 weeks after dietary intervention post-crossover
Worsening proteinuria
Time Frame: 4 weeks after dietary intervention pre-crossover and 4 weeks after dietary intervention post-crossover
Increase in urinary albumin excretion rate (AER) ≥30 mg/day
4 weeks after dietary intervention pre-crossover and 4 weeks after dietary intervention post-crossover
Proteinuria
Time Frame: 4 weeks after dietary intervention pre-crossover and 4 weeks after dietary intervention post-crossover
New-onset urinary albumin excretion rate (AER) ≥30 mg/day
4 weeks after dietary intervention pre-crossover and 4 weeks after dietary intervention post-crossover

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Irvine

Investigators

  • Principal Investigator: Ekamol Tantisattamo, MD, MPH, University of California, Irvine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 3, 2021

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

September 3, 2021

First Submitted That Met QC Criteria

September 3, 2021

First Posted (Actual)

September 13, 2021

Study Record Updates

Last Update Posted (Actual)

December 2, 2022

Last Update Submitted That Met QC Criteria

November 30, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS#2021-6478

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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