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Low Sodium Diet for High Blood Pressure in Kidney Donors (SPLID Trial)
N/A
Recruiting
Led By Ekamol Tantisattamo, MD, MPH
Research Sponsored by University of California, Irvine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks after dietary intervention pre-crossover and 4 weeks after dietary intervention post-crossover
Awards & highlights
SPLID Trial Summary
This trial is to see if a low sodium diet can help control blood pressure in kidney donors.
Who is the study for?
This trial is for living kidney donors aged 18 or older who donated a kidney 5-12 months ago, have blood pressure below 160 mmHg, and can attend all study visits. They must not smoke heavily, drink excessively, have advanced kidney issues or certain medical conditions that limit survival or adherence to the study protocol.Check my eligibility
What is being tested?
The study tests if a low sodium diet helps maintain normal blood pressure in living kidney donors compared to a high sodium diet. It's designed to check how feasible this approach is and whether it effectively controls blood pressure post-donation.See study design
What are the potential side effects?
Since the intervention involves dietary changes rather than medication, side effects may include symptoms related to dietary adjustment such as cravings or temporary discomfort but are generally minimal compared to drug interventions.
SPLID Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks after dietary intervention pre-crossover and 4 weeks after dietary intervention post-crossover
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks after dietary intervention pre-crossover and 4 weeks after dietary intervention post-crossover
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in systolic and diastolic blood pressure from baseline to post-treatment between the two treatment groups
Secondary outcome measures
Hypertension
Proteinuria
Worsening kidney function
+1 moreSPLID Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: lowsodiumExperimental Treatment1 Intervention
Participants in this arm will be guided to have low dietary sodium intake of <2.3 g/day (<100 mmol/day) for 4 weeks.
Group II: highsodiumActive Control1 Intervention
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.
Find a Location
Who is running the clinical trial?
University of California, IrvineLead Sponsor
542 Previous Clinical Trials
1,921,977 Total Patients Enrolled
Ekamol Tantisattamo, MD, MPHPrincipal InvestigatorUniversity of California, Irvine
Media Library
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the current study enrolling new participants?
"According to clinicaltrials.gov, this research study is presently enrolling participants and has been since November 3rd 2021 - the last update was on November 30th 2022."
Answered by AI
What is the maximum capacity of participants in this experiment?
"Correct. According to information on clinicaltrials.gov, the trial first posted on November 3rd 2021 is actively looking for enrollees. A total of 24 patients from 2 different sites need to be recruited."
Answered by AI
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