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NCT04764253 · ClinicalTrials.gov registry record · NA
Examining the Individual Response to a Restricted Sodium Diet in Hypertensive Patients
A NA study of Hypertension, sponsored by The University of Texas Health Science Center at San Antonio.
- Completed
- Registry status
- NA
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT04764253: Completed NA study of Hypertension, sponsored by The University of Texas Health Science Center at San Antonio.
NCT04764253 is a NA study of Hypertension that has completed, run by The University of Texas Health Science Center at San Antonio. The registered enrollment target is 40 participants, below the 3,507-participant average among 470 other Hypertension trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04764253, a NA study of Hypertension, has completed, sponsored by The University of Texas Health Science Center at San Antonio.
- COMPLETED
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
Excessive dietary sodium intake is an independent risk factor for hypertension and cardiovascular disease. A vast array of efforts have tried to reduce sodium consumption based on evidence indicating a public health benefit. Yet this benefit has been questioned, mainly based on studies showing variability in individual responses to a sodium-restricted diet (SRD). The effects of an SRD on blood pressure vary, and adherence to an SRD is not optimal. The original Sodium Watchers Program (R01NR012967) was developed and implemented by Dr. Misook Chung (University of Kentucky). In this pilot study, the modified Sodium Watchers Program will propose improving adherence to an SRD through education and digital self-monitoring for daily sodium intake and blood pressure. In addition, few studies have examined individuals' metabolic responses to the SRD. In a secondary analysis, we further will examine genetic variants associated with salt sensitivity and whether such a genetic component is associated with sodium excretion and BP control. A total of 40 hypertensive patients will be randomly assigned to the intervention (n=20) or control group (n=20). The intervention group will receive 8-week education sessions remotely using a video conferencing program. All participants will collect a 24-hour urine specimen for sodium excretion and a total of 4.0ml of peripheral blood will be drawn for salt sensitivity during baseline visit. All participants will be asked to log their activities in real-time, including food intake and in-home BP monitoring using Fitbit and accompanied mobile app and BP monitor.
Primary Outcome
Blood pressure (BP) will be measured using a Vital Signs Monitor 300 Series model (WelchAllyn, US). The midsection circumference of the dominant upper arm will be measured with a tape measure, and the proper sized cuff will be selected accordingly. Systolic and diastolic BP will be measured in the dominant arm twice with a 2-minute rest period between measures; two measures will be averaged.
Conditions Studied
Interventions
- BEHAVIORAL Modified Sodium Watcher Program + Digital Self-Monitoring
- BEHAVIORAL Usual care + Digital Self-Monitoring
Study Locations (1)
Texas
- The University of Texas Health Science Center at San Antonio - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2021-02-11 |
| Est. Completion | 2023-09-30 |
| Phase | NA |
What the finished NCT04764253 record still lists
NCT04764253 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 3,507-participant average among 470 other Hypertension trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Hypertension appearing as the primary indexed condition, and to 2 interventions - of which Modified Sodium Watcher Program + Digital Self-Monitoring is the first listed.
NCT04764253 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04764253 about?
NCT04764253 is a clinical study titled "Examining the Individual Response to a Restricted Sodium Diet in Hypertensive Patients". Excessive dietary sodium intake is an independent risk factor for hypertension and cardiovascular disease. A vast array of efforts have tried to reduce sodium consumption based on evidence indicating a public health benefit. Yet this benefit has been questioned, mainly based on studies showing varia...
What is the current status of trial NCT04764253?
This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2021-02-11. Estimated completion is 2023-09-30.
What conditions does trial NCT04764253 study?
This clinical trial studies the following conditions: Hypertension.
What interventions are being tested in trial NCT04764253?
The interventions under investigation include: Modified Sodium Watcher Program + Digital Self-Monitoring (BEHAVIORAL), Usual care + Digital Self-Monitoring (BEHAVIORAL).
Who is sponsoring clinical trial NCT04764253?
This trial is sponsored by The University of Texas Health Science Center at San Antonio, which has 378 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04764253 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hypertension
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04764253's enrollment target sits among peer trials
40 384th of 470 higher than 80 of 470 other Hypertension trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hypertension trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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