Trial Outcomes & Findings for Effect of Dietary Sodium Intake on Vascular Endothelium (NCT NCT01550315)
NCT ID: NCT01550315
Last Updated: 2022-01-05
Results Overview
The primary analysis will involve a non-parametric, paired, Signed Rank test of flow mediated dilation (FMD) between all subjects (POTS \& control subjects) on the high sodium diet vs low sodium diet
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
27 participants
Primary outcome timeframe
FMD was assessed on the morning of day 7, after 6 days of being on either a high salt diet or a low salt diet.
Results posted on
2022-01-05
Participant Flow
Participant milestones
| Measure |
High Sodium First- POTS
POTS patients received a high salt diet (300 mEq/day) for 6 days in a randomized crossover design and two weeks after, were crossover to receive a low high diet for 6 days
|
Low Sodium Diet First-POTS
POTS patients received a low salt diet (10 mEq/day) for 6 days in a randomized crossover design, and two weeks later received a high salt diet.
|
High Sodium First- Controls
Healthy Controls received a high salt diet (300 mEq/day) for 6 days in a randomized crossover design and two weeks after, received a low high diet for 6 days
|
Low Sodium First-Controls
Healthy Controls received a low salt diet (10 mEq/day) for 6 days in a randomized crossover design, and two weeks later received a high salt diet.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
7
|
6
|
7
|
|
Overall Study
COMPLETED
|
7
|
7
|
6
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Dietary Sodium Intake on Vascular Endothelium
Baseline characteristics by cohort
| Measure |
All Study POTS
n=14 Participants
POTS patients received high sodium diet for 4-5 days prior to study day. Then received either a high sodium diet (300 mEq/day) diet for 6 days, then after 2 weeks were randomized in a crossover design to receive a low sodium diet (10 mEq/day) diet for 6 days, or viceversa (first low then high salt diet). All POTS patients received both diets.
Evaluation of Forearm-Mediated Dilation: The arm will be kept extended and immobilized at heart level. Brachial artery diameter will be measured using a high resolution ultrasonography using a linear array probe with a 5 to 17 MHz frequency range. The brachial artery will be imaged in longitudinal sections, 5-10 cm proximal to placement of an occlusion cuff in the dominant forearm just below the antecubital fossa. The probe will be held with a stereotaxic holder with micrometer movement capabilities.
|
All Study Controls
n=13 Participants
Healthy controls received high sodium diet for 4-5 days prior to study day. Then received either a high sodium diet (300 mEq/day) diet for 6 days, then after 2 weeks were randomized in a crossover design to receive a low sodium diet (10 mEq/day) diet for 6 days, or viceversa (first low then high salt diet). All healthy controls received both diets.
Evaluation of Forearm-Mediated Dilation: The arm will be kept extended and immobilized at heart level. Brachial artery diameter will be measured using a high resolution ultrasonography using a linear array probe with a 5 to 17 MHz frequency range. The brachial artery will be imaged in longitudinal sections, 5-10 cm proximal to placement of an occlusion cuff in the dominant forearm just below the antecubital fossa. The probe will be held with a stereotaxic holder with micrometer movement capabilities.
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35 years
STANDARD_DEVIATION 8 • n=5 Participants
|
31 years
STANDARD_DEVIATION 6 • n=7 Participants
|
33 years
STANDARD_DEVIATION 7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
00 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: FMD was assessed on the morning of day 7, after 6 days of being on either a high salt diet or a low salt diet.The primary analysis will involve a non-parametric, paired, Signed Rank test of flow mediated dilation (FMD) between all subjects (POTS \& control subjects) on the high sodium diet vs low sodium diet
Outcome measures
| Measure |
High Sodium POTS
n=14 Participants
POTS patients received a high sodium diet for 4-5 days prior to study day. After enrollment, they received a high salt diet (300 mEq/day) diet for 6 days in a randomized crossover design.
Evaluation of Forearm-Mediated Dilation: The arm will be kept extended and immobilized at heart level. Brachial artery diameter will be measured using a high resolution ultrasonography using a linear array probe with a 5 to 17 MHz frequency range. The brachial artery will be imaged in longitudinal sections, 5-10 cm proximal to placement of an occlusion cuff in the dominant forearm just below the antecubital fossa. The probe will be held with a stereotaxic holder with micrometer movement capabilities.
|
Low Sodium Diet POTS
n=14 Participants
POTS patients received a high sodium diet for 4-5 days prior to study day. After enrollment, they received either a low-sodium (LS; 10 mEq/day) diet for 6 days.
Evaluation of Forearm-Mediated Dilation: The arm will be kept extended and immobilized at heart level. Brachial artery diameter will be measured using a high resolution ultrasonography using a linear array probe with a 5 to 17 MHz frequency range. The brachial artery will be imaged in longitudinal sections, 5-10 cm proximal to placement of an occlusion cuff in the dominant forearm just below the antecubital fossa. The probe will be held with a stereotaxic holder with micrometer movement capabilities.
|
High Sodium Controls
n=13 Participants
Healthy controls received a high sodium diet for 4-5 days prior to study day. After enrollment, they received a high salt diet (300 mEq/day) diet for 6 days in a randomized crossover design.
Evaluation of Forearm-Mediated Dilation: The arm will be kept extended and immobilized at heart level. Brachial artery diameter will be measured using a high resolution ultrasonography using a linear array probe with a 5 to 17 MHz frequency range. The brachial artery will be imaged in longitudinal sections, 5-10 cm proximal to placement of an occlusion cuff in the dominant forearm just below the antecubital fossa. The probe will be held with a stereotaxic holder with micrometer movement capabilities.
|
Low Sodium Controls
n=13 Participants
Healthy controls received a high sodium diet for 4-5 days prior to study day. After enrollment, they received either a low-sodium (LS; 10 mEq/day) diet for 6 days.
Evaluation of Forearm-Mediated Dilation: The arm will be kept extended and immobilized at heart level. Brachial artery diameter will be measured using a high resolution ultrasonography using a linear array probe with a 5 to 17 MHz frequency range. The brachial artery will be imaged in longitudinal sections, 5-10 cm proximal to placement of an occlusion cuff in the dominant forearm just below the antecubital fossa. The probe will be held with a stereotaxic holder with micrometer movement capabilities.
|
|---|---|---|---|---|
|
FMD (% Change)
|
12.75 percentage of change
Standard Deviation 43.77
|
11.65 percentage of change
Standard Deviation 4.93
|
11.43 percentage of change
Standard Deviation 4.26
|
12.75 percentage of change
Standard Deviation 4.49
|
Adverse Events
High Sodium - POTS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Low Sodium Diet - POTS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
High Sodium - Controls
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Low Sodium - Controls
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place