Trial Outcomes & Findings for Dietary Salt in Postural Tachycardia Syndrome (NCT NCT01547117)
NCT ID: NCT01547117
Last Updated: 2022-02-22
Results Overview
Plasma volume (PV) was determined by the indicator tracer-dilution technique, using the DAXOR Blood Volume Analyzer (BVA)-100 system (DAXOR Corporation), on Day 7 of the low sodium and high sodium dietary interventions. Outcome data are the absolute values for PV on Day 7 for each diet.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
38 participants
Primary outcome timeframe
after 7 days of each dietary sodium level
Results posted on
2022-02-22
Participant Flow
Healthy Participants: 17 were enrolled and randomized. 1 withdrew due to scheduling. 1 withdrew with migraines in phase 1 (low Na+). 2 withdrew in phase 1 (high Na+): 1 unable to tolerate study diet and another had difficulty cooperating with investigators. Postural Tachycardia Syndrome (POTS): 21 were enrolled and randomized. 6 withdrew before baseline due to age (1), pregnancy (1), prohibited meds (3), and scheduling (1). A 7th patient withdrew during phase 1 (high Na+) due to family illness.
Participant milestones
| Measure |
Healthy Participants-Low Na+ Then High Na+
Healthy controls were randomly assigned the order of dietary sodium (Na+) levels. After baseline labs on Day 0 and 1 day on diet with 150 milliequivalents (mEq) sodium/day, 12 participants consumed low Na+ diet (10 mEq sodium/day; LS) for 6 days followed in at least 1 month by baseline labs, 1 day of 150 mEq sodium/day and 6 days of high Na+ diet (300 mEq sodium/day; HS). All procedures were performed at both levels.
|
Healthy Participants-High Na+ Then Low Na+
Healthy controls were randomly assigned the order of dietary sodium (Na+) levels. After baseline labs on Day 0 and 1 day on diet with 150 mEq sodium/day, 5 participants consumed high Na+ diet (300 mEq sodium/day; HS) for 6 days followed in at least 1 month by baseline labs, 1 day of 150 mEq sodium/day and 6 days of low Na+ diet (10 mEq sodium/day; LS). All procedures were performed at both levels.
|
Patients With POTS-Low Na+ Then High Na+
Patients with POTS were randomly assigned the order of dietary sodium (Na+) levels. After baseline labs on Day 0 and 1 day on diet with 150 mEq sodium/day, 10 participants consumed low Na+ diet (10 mEq sodium/day; LS) for 6 days followed in at least 1 month by baseline labs, 1 day of 150 mEq sodium/day and 6 days of high Na+ diet (300 mEq sodium/day; HS). All procedures were performed at both levels.
|
Patients With POTS-High Na+ Then Low Na+
Patients with POTS were randomly assigned the order of dietary sodium (Na+) levels. After baseline labs on Day 0 and 1 day on diet with 150 mEq sodium/day, 11 participants consumed high Na+ diet (300 mEq sodium/day; HS) for 6 days followed in at least 1 month by baseline labs, 1 day of 150 mEq sodium/day and 6 days of low Na+ diet (10 mEq sodium/day; LS). All procedures were performed at both levels.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
5
|
10
|
11
|
|
Overall Study
Phase 1 Baseline Labs
|
12
|
4
|
8
|
7
|
|
Overall Study
Phase 1-150 mEq Sodium/Day
|
12
|
4
|
8
|
7
|
|
Overall Study
Phase 1-start Low Sodium or High Sodium Diet
|
12
|
4
|
8
|
7
|
|
Overall Study
Phase 1-finish
|
11
|
2
|
8
|
6
|
|
Overall Study
Phase 2-150 mEq Sodium/Day
|
11
|
2
|
8
|
6
|
|
Overall Study
Phase 2-start Low Sodium or High Sodium Diet
|
11
|
2
|
8
|
6
|
|
Overall Study
Phase 2-finish
|
11
|
2
|
8
|
6
|
|
Overall Study
COMPLETED
|
11
|
2
|
8
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
2
|
5
|
Reasons for withdrawal
| Measure |
Healthy Participants-Low Na+ Then High Na+
Healthy controls were randomly assigned the order of dietary sodium (Na+) levels. After baseline labs on Day 0 and 1 day on diet with 150 milliequivalents (mEq) sodium/day, 12 participants consumed low Na+ diet (10 mEq sodium/day; LS) for 6 days followed in at least 1 month by baseline labs, 1 day of 150 mEq sodium/day and 6 days of high Na+ diet (300 mEq sodium/day; HS). All procedures were performed at both levels.
|
Healthy Participants-High Na+ Then Low Na+
Healthy controls were randomly assigned the order of dietary sodium (Na+) levels. After baseline labs on Day 0 and 1 day on diet with 150 mEq sodium/day, 5 participants consumed high Na+ diet (300 mEq sodium/day; HS) for 6 days followed in at least 1 month by baseline labs, 1 day of 150 mEq sodium/day and 6 days of low Na+ diet (10 mEq sodium/day; LS). All procedures were performed at both levels.
|
Patients With POTS-Low Na+ Then High Na+
Patients with POTS were randomly assigned the order of dietary sodium (Na+) levels. After baseline labs on Day 0 and 1 day on diet with 150 mEq sodium/day, 10 participants consumed low Na+ diet (10 mEq sodium/day; LS) for 6 days followed in at least 1 month by baseline labs, 1 day of 150 mEq sodium/day and 6 days of high Na+ diet (300 mEq sodium/day; HS). All procedures were performed at both levels.
|
Patients With POTS-High Na+ Then Low Na+
Patients with POTS were randomly assigned the order of dietary sodium (Na+) levels. After baseline labs on Day 0 and 1 day on diet with 150 mEq sodium/day, 11 participants consumed high Na+ diet (300 mEq sodium/day; HS) for 6 days followed in at least 1 month by baseline labs, 1 day of 150 mEq sodium/day and 6 days of low Na+ diet (10 mEq sodium/day; LS). All procedures were performed at both levels.
|
|---|---|---|---|---|
|
Overall Study
Physician Decision
|
0
|
1
|
1
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
1
|
2
|
Baseline Characteristics
Dietary Salt in Postural Tachycardia Syndrome
Baseline characteristics by cohort
| Measure |
Healthy Participants-Low Na+ Then High Na+
n=11 Participants
Healthy controls were randomly assigned the order of dietary sodium (Na+) levels. After 1 day on diet with 150 mEq sodium/day, participants consumed low Na+ diet (10 mEq sodium/day; LS) for 6 days followed in at least 1 month by 1 day of 150 mEq sodium/day and 6 days of high Na+ diet (300 mEq sodium/day; HS). All procedures were performed at both levels.
|
Healthy Participants-High Na+ Then Low Na+
n=2 Participants
Healthy controls were randomly assigned the order of dietary sodium (Na+) levels. After 1 day on diet with 150 mEq sodium/day, participants consumed high Na+ diet (300 mEq sodium/day; HS) for 6 days followed in at least 1 month by 1 day of 150 mEq sodium/day and 6 days of low Na+ diet (10 mEq sodium/day; LS). All procedures were performed at both levels.
|
Patients With POTS-Low Na+ Then High Na+
n=8 Participants
Patients with POTS were randomly assigned the order of dietary sodium (Na+) levels. After 1 day on diet with 150 mEq sodium/day, participants consumed low Na+ diet (10 mEq sodium/day; LS) for 6 days followed in at least 1 month by 1 day of 150 mEq sodium/day and 6 days of high Na+ diet (300 mEq sodium/day; HS). All procedures were performed at both levels.
|
Patients With POTS-High Na+ Then Low Na+
n=6 Participants
Patients with POTS were randomly assigned the order of dietary sodium (Na+) levels. After 1 day on diet with 150 mEq sodium/day, participants consumed high Na+ diet (300 mEq sodium/day; HS) for 6 days followed in at least 1 month by 1 day of 150 mEq sodium/day and 6 days of low Na+ diet (10 mEq sodium/day; LS). All procedures were performed at both levels.
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
31 years
STANDARD_DEVIATION 6 • n=5 Participants
|
35 years
STANDARD_DEVIATION 10 • n=7 Participants
|
36 years
STANDARD_DEVIATION 9 • n=5 Participants
|
32 years
STANDARD_DEVIATION 6 • n=4 Participants
|
33 years
STANDARD_DEVIATION 7 • n=21 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
2 participants
n=7 Participants
|
8 participants
n=5 Participants
|
6 participants
n=4 Participants
|
27 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: after 7 days of each dietary sodium levelPopulation: No data analysis for 1 healthy control who had poor venous access on Day 7 of the high sodium diet.
Plasma volume (PV) was determined by the indicator tracer-dilution technique, using the DAXOR Blood Volume Analyzer (BVA)-100 system (DAXOR Corporation), on Day 7 of the low sodium and high sodium dietary interventions. Outcome data are the absolute values for PV on Day 7 for each diet.
Outcome measures
| Measure |
Healthy Participants Who Consumed Low Sodium Diet as Intervention A or Intervention B
n=13 Participants
Healthy controls were randomly assigned the order of dietary sodium levels. All procedures were performed at both levels. Results below were after the low sodium diet.
Plasma Volume: Using injection of iodinated I-131 tagged human serum albumin, blood samples were drawn before and 30 minutes after injection on Day 7 of the diet.
|
Healthy Participants Who Consumed High Sodium Diet as Intervention A or Intervention B
n=12 Participants
Healthy controls were randomly assigned the order of dietary sodium levels. All procedures were performed at both levels. Results below were after the high sodium diet.
Plasma Volume: Using injection of iodinated I-131 tagged human serum albumin, blood samples were drawn before and 30 minutes after injection on Day 7 of the diet.
|
Postural Tachycardia Syndrome (POTS) Participants Who Consumed Low Sodium Diet.
n=14 Participants
Patients were randomly assigned the order of dietary sodium levels. Results below were after the low sodium diet.
Plasma Volume: Using injection of I-131 tagged human serum albumin, blood samples were drawn before and 30 minutes after injection on Day 7 of the diet.
|
Postural Tachycardia Syndrome (POTS) Participants Who Consumed High Sodium Diet.
n=14 Participants
Patients were randomly assigned the order of dietary sodium levels. Results below were after the high sodium diet.
Plasma Volume: Using injection of I-131 tagged human serum albumin, blood samples were drawn before and 30 minutes after injection on Day 7 of the diet.
|
|---|---|---|---|---|
|
Plasma Volume
|
2805 mL
Interval 2445.0 to 2949.0
|
3032 mL
Interval 2620.0 to 3482.0
|
2362 mL
Interval 2161.0 to 2715.0
|
2633 mL
Interval 2468.0 to 2961.0
|
SECONDARY outcome
Timeframe: Upright blood samples were collected after up to 30 minutes of standing on the 7th day of each dietary sodium interventionPopulation: Healthy Controls on Low Sodium diet - 1 missing blood sample; Healthy Controls on High Sodium diet - 3 missing blood samples, 2 samples with insufficient volume for analysis; POTS patients on Low Sodium diet - 1 missing blood sample; POTS patients on High Sodium diet - 2 missing blood samples
Whether upright plasma renin activity was modified appropriately by changes in dietary sodium in POTS \& healthy controls. Outcome data are the absolute values for upright plasma renin activity on Day 7 of each diet.
Outcome measures
| Measure |
Healthy Participants Who Consumed Low Sodium Diet as Intervention A or Intervention B
n=12 Participants
Healthy controls were randomly assigned the order of dietary sodium levels. All procedures were performed at both levels. Results below were after the low sodium diet.
Plasma Volume: Using injection of iodinated I-131 tagged human serum albumin, blood samples were drawn before and 30 minutes after injection on Day 7 of the diet.
|
Healthy Participants Who Consumed High Sodium Diet as Intervention A or Intervention B
n=8 Participants
Healthy controls were randomly assigned the order of dietary sodium levels. All procedures were performed at both levels. Results below were after the high sodium diet.
Plasma Volume: Using injection of iodinated I-131 tagged human serum albumin, blood samples were drawn before and 30 minutes after injection on Day 7 of the diet.
|
Postural Tachycardia Syndrome (POTS) Participants Who Consumed Low Sodium Diet.
n=13 Participants
Patients were randomly assigned the order of dietary sodium levels. Results below were after the low sodium diet.
Plasma Volume: Using injection of I-131 tagged human serum albumin, blood samples were drawn before and 30 minutes after injection on Day 7 of the diet.
|
Postural Tachycardia Syndrome (POTS) Participants Who Consumed High Sodium Diet.
n=12 Participants
Patients were randomly assigned the order of dietary sodium levels. Results below were after the high sodium diet.
Plasma Volume: Using injection of I-131 tagged human serum albumin, blood samples were drawn before and 30 minutes after injection on Day 7 of the diet.
|
|---|---|---|---|---|
|
Magnitude of Suppression of Plasma Renin Activity (From Low Sodium to High Sodium Diets)
|
7.8 ng/mL/hr
Interval 3.3 to 13.9
|
1.0 ng/mL/hr
Interval 0.8 to 1.9
|
24.4 ng/mL/hr
Interval 10.1 to 26.7
|
2.7 ng/mL/hr
Interval 0.7 to 4.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Upright blood samples were collected after up to 30 minutes of standing on the 7th day of each dietary sodium interventionPopulation: Samples were analyzed from each participant
Whether upright serum aldosterone was modified appropriately by changes in dietary sodium in POTS patients \& healthy controls. Outcome data are the absolute values for upright serum aldosterone on Day 7 of each diet.
Outcome measures
| Measure |
Healthy Participants Who Consumed Low Sodium Diet as Intervention A or Intervention B
n=13 Participants
Healthy controls were randomly assigned the order of dietary sodium levels. All procedures were performed at both levels. Results below were after the low sodium diet.
Plasma Volume: Using injection of iodinated I-131 tagged human serum albumin, blood samples were drawn before and 30 minutes after injection on Day 7 of the diet.
|
Healthy Participants Who Consumed High Sodium Diet as Intervention A or Intervention B
n=13 Participants
Healthy controls were randomly assigned the order of dietary sodium levels. All procedures were performed at both levels. Results below were after the high sodium diet.
Plasma Volume: Using injection of iodinated I-131 tagged human serum albumin, blood samples were drawn before and 30 minutes after injection on Day 7 of the diet.
|
Postural Tachycardia Syndrome (POTS) Participants Who Consumed Low Sodium Diet.
n=14 Participants
Patients were randomly assigned the order of dietary sodium levels. Results below were after the low sodium diet.
Plasma Volume: Using injection of I-131 tagged human serum albumin, blood samples were drawn before and 30 minutes after injection on Day 7 of the diet.
|
Postural Tachycardia Syndrome (POTS) Participants Who Consumed High Sodium Diet.
n=14 Participants
Patients were randomly assigned the order of dietary sodium levels. Results below were after the high sodium diet.
Plasma Volume: Using injection of I-131 tagged human serum albumin, blood samples were drawn before and 30 minutes after injection on Day 7 of the diet.
|
|---|---|---|---|---|
|
Magnitude of Suppression of Serum Aldosterone (From Low Sodium to High Sodium Diets)
|
444 ng/dL
Interval 277.0 to 515.0
|
74 ng/dL
Interval 52.0 to 129.0
|
455 ng/dL
Interval 359.0 to 650.0
|
64 ng/dL
Interval 52.0 to 91.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Supine and upright heart rates were measured on Day 7 of High Sodium and Low Sodium diet.Population: Data is not included for 1 patient with POTS on a Low Sodium diet since that patient was unable to stand for even 1 minute.
Whether the magnitude of the heart rate increase that occurs in patients with POTS when moving from a supine to an upright position is attenuated by a High Sodium diet relative to a Low Sodium diet. Heart rate was assessed after overnight rest and fasting after midnight, following at least 60 minutes of lying quietly. Heart rate was then measured at intervals after subjects had been standing for up to 30 minutes (as tolerated). Orthostatic tachycardia was calculated as the difference between standing and lying heart rates. Data are presented for 5 minutes standing (or maximal stand if \<5 minutes) since several patients were unable to stand for 10 minutes. Data in POTS patients were compared to that of Healthy Controls.
Outcome measures
| Measure |
Healthy Participants Who Consumed Low Sodium Diet as Intervention A or Intervention B
n=13 Participants
Healthy controls were randomly assigned the order of dietary sodium levels. All procedures were performed at both levels. Results below were after the low sodium diet.
Plasma Volume: Using injection of iodinated I-131 tagged human serum albumin, blood samples were drawn before and 30 minutes after injection on Day 7 of the diet.
|
Healthy Participants Who Consumed High Sodium Diet as Intervention A or Intervention B
n=13 Participants
Healthy controls were randomly assigned the order of dietary sodium levels. All procedures were performed at both levels. Results below were after the high sodium diet.
Plasma Volume: Using injection of iodinated I-131 tagged human serum albumin, blood samples were drawn before and 30 minutes after injection on Day 7 of the diet.
|
Postural Tachycardia Syndrome (POTS) Participants Who Consumed Low Sodium Diet.
n=13 Participants
Patients were randomly assigned the order of dietary sodium levels. Results below were after the low sodium diet.
Plasma Volume: Using injection of I-131 tagged human serum albumin, blood samples were drawn before and 30 minutes after injection on Day 7 of the diet.
|
Postural Tachycardia Syndrome (POTS) Participants Who Consumed High Sodium Diet.
n=14 Participants
Patients were randomly assigned the order of dietary sodium levels. Results below were after the high sodium diet.
Plasma Volume: Using injection of I-131 tagged human serum albumin, blood samples were drawn before and 30 minutes after injection on Day 7 of the diet.
|
|---|---|---|---|---|
|
Magnitude of Orthostatic Tachycardia
|
23 beats per minute
Interval 19.0 to 36.0
|
19 beats per minute
Interval 11.0 to 32.0
|
60 beats per minute
Interval 55.0 to 64.0
|
46 beats per minute
Interval 32.0 to 55.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Upright symptoms were assessed on the 7th day of diet.Population: Upright symptom scores were inadvertently not obtained for the following number of participants: Healthy Participants on Low Sodium diet: 3 Healthy Participants on High Sodium diet: 2 Patients with POTS on Low Sodium diet: 5 Patients with POTS on High Sodium diet: 6
Whether upright symptoms were improved in patients with POTS on a High Sodium diet relative to a Low Sodium diet. Patients were asked to report their standing symptom burden at the end of the Stand portion of the posture study, using the Vanderbilt Orthostatic Symptoms Scale (VOSS). They rated the severity of nine symptoms (palpitations, lightheadedness, mental confusion, blurred vision, shortness of breath, tremulousness, chest discomfort, headache, and nausea) on a scale from a minimum of 0 (reflecting an absence of symptoms) to a maximum of 10. The sum of the scores for the 9 symptoms was used to measure orthostatic symptom burden. Higher scores represent worse symptoms.
Outcome measures
| Measure |
Healthy Participants Who Consumed Low Sodium Diet as Intervention A or Intervention B
n=10 Participants
Healthy controls were randomly assigned the order of dietary sodium levels. All procedures were performed at both levels. Results below were after the low sodium diet.
Plasma Volume: Using injection of iodinated I-131 tagged human serum albumin, blood samples were drawn before and 30 minutes after injection on Day 7 of the diet.
|
Healthy Participants Who Consumed High Sodium Diet as Intervention A or Intervention B
n=11 Participants
Healthy controls were randomly assigned the order of dietary sodium levels. All procedures were performed at both levels. Results below were after the high sodium diet.
Plasma Volume: Using injection of iodinated I-131 tagged human serum albumin, blood samples were drawn before and 30 minutes after injection on Day 7 of the diet.
|
Postural Tachycardia Syndrome (POTS) Participants Who Consumed Low Sodium Diet.
n=9 Participants
Patients were randomly assigned the order of dietary sodium levels. Results below were after the low sodium diet.
Plasma Volume: Using injection of I-131 tagged human serum albumin, blood samples were drawn before and 30 minutes after injection on Day 7 of the diet.
|
Postural Tachycardia Syndrome (POTS) Participants Who Consumed High Sodium Diet.
n=8 Participants
Patients were randomly assigned the order of dietary sodium levels. Results below were after the high sodium diet.
Plasma Volume: Using injection of I-131 tagged human serum albumin, blood samples were drawn before and 30 minutes after injection on Day 7 of the diet.
|
|---|---|---|---|---|
|
Upright Symptom Score
|
1 score on a scale
Interval 0.0 to 4.0
|
0 score on a scale
Interval 0.0 to 3.0
|
30 score on a scale
Interval 18.0 to 39.0
|
19 score on a scale
Interval 10.0 to 26.0
|
Adverse Events
Healthy Participants Who Consumed Low Sodium Diet as Intervention A or Intervention B
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Healthy Participants Who Consumed High Sodium Diet as Intervention A or Intervention B
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Postural Tachycardia Syndrome (POTS) Participants Who Consumed Low Sodium Diet.
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Postural Tachycardia Syndrome (POTS) Participants Who Consumed High Sodium Diet.
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Healthy Participants Who Consumed Low Sodium Diet as Intervention A or Intervention B
n=13 participants at risk
Healthy controls were randomly assigned the order of dietary sodium levels. All procedures were performed at both levels. Results below were after the low sodium diet.
|
Healthy Participants Who Consumed High Sodium Diet as Intervention A or Intervention B
n=13 participants at risk
Healthy controls were randomly assigned the order of dietary sodium levels. All procedures were performed at both levels. Results below were after the high sodium diet.
|
Postural Tachycardia Syndrome (POTS) Participants Who Consumed Low Sodium Diet.
n=14 participants at risk
Patients were randomly assigned the order of dietary sodium levels. Results below were after the low sodium diet.
|
Postural Tachycardia Syndrome (POTS) Participants Who Consumed High Sodium Diet.
n=14 participants at risk
Patients were randomly assigned the order of dietary sodium levels. Results below were after the high sodium diet.
|
|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
mass
|
0.00%
0/13 • Adverse event data were collected through discharge on the last day of phase 2 of the study. This would have been Day 8 if Low Sodium diet or Day 7 if High Sodium diet.
Adverse event information was collected for any untoward or unfavorable medical occurence in a participant including any abnormal sign, symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Events were self-reported by participants.
|
7.7%
1/13 • Number of events 1 • Adverse event data were collected through discharge on the last day of phase 2 of the study. This would have been Day 8 if Low Sodium diet or Day 7 if High Sodium diet.
Adverse event information was collected for any untoward or unfavorable medical occurence in a participant including any abnormal sign, symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Events were self-reported by participants.
|
0.00%
0/14 • Adverse event data were collected through discharge on the last day of phase 2 of the study. This would have been Day 8 if Low Sodium diet or Day 7 if High Sodium diet.
Adverse event information was collected for any untoward or unfavorable medical occurence in a participant including any abnormal sign, symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Events were self-reported by participants.
|
0.00%
0/14 • Adverse event data were collected through discharge on the last day of phase 2 of the study. This would have been Day 8 if Low Sodium diet or Day 7 if High Sodium diet.
Adverse event information was collected for any untoward or unfavorable medical occurence in a participant including any abnormal sign, symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Events were self-reported by participants.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place