Trial Outcomes & Findings for Dietary Sodium's Effect on Urinary Sodium and Dopamine Excretion in Patients With Postural Tachycardia Syndrome (NCT NCT01563107)
NCT ID: NCT01563107
Last Updated: 2022-01-25
Results Overview
Amount of sodium excreted in urine over 24hr ending on Day 7
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
38 participants
Primary outcome timeframe
Day 6 am - Day 7 am for each dietary sodium level
Results posted on
2022-01-25
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 with150 milliequivalent (mEq) sodium/day, 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 milliequivalents (mEq) sodium/day,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, 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 with150 mEq sodium/day, 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 with150 milliequivalent (mEq) sodium/day, 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 milliequivalents (mEq) sodium/day,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, 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 with150 mEq sodium/day, 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 Sodium's Effect on Urinary Sodium and Dopamine Excretion in Patients With 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
|
HealthyParticipants-HighNa+ 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: Day 6 am - Day 7 am for each dietary sodium levelPopulation: 24hr urine samples ending on Day 7 were collected for 13 healthy controls and 14 patients with POTS
Amount of sodium excreted in urine over 24hr ending on Day 7
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. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the final urine collection which ended on Day 7.
|
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. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the final urine collection which ended on Day 7.
|
Postural Tachycardia Syndrome (POTS) Participants Who Consumed Low Sodium Diet.
n=14 Participants
Patients with POTS were randomly assigned the order of dietary sodium levels. All procedures were performed at both levels. Results below were after the low sodium diet. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the final urine collection which ended on Day 7.
|
Postural Tachycardia Syndrome (POTS) Participants Who Consumed High Sodium Diet
n=14 Participants
Patients with POTS were randomly assigned the order of dietary sodium levels. All procedures were performed at both levels. Results below were after the high sodium diet. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the final urine collection which ended on Day 7.
|
|---|---|---|---|---|
|
24hr Urinary Sodium
|
16.8 milliequivalents
Interval 12.0 to 26.6
|
280 milliequivalents
Interval 232.0 to 306.0
|
14.7 milliequivalents
Interval 10.8 to 22.6
|
245 milliequivalents
Interval 189.0 to 264.0
|
PRIMARY outcome
Timeframe: Between Day 6 am - Day 7 am of each dietary sodium levelPopulation: 24hr urine samples ending on Day 7 were collected for 13 healthy controls and 14 patients with POTS
Amount of dopamine excreted in urine over 24 hours ending on Day 7
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. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the final urine collection which ended on Day 7.
|
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. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the final urine collection which ended on Day 7.
|
Postural Tachycardia Syndrome (POTS) Participants Who Consumed Low Sodium Diet.
n=14 Participants
Patients with POTS were randomly assigned the order of dietary sodium levels. All procedures were performed at both levels. Results below were after the low sodium diet. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the final urine collection which ended on Day 7.
|
Postural Tachycardia Syndrome (POTS) Participants Who Consumed High Sodium Diet
n=14 Participants
Patients with POTS were randomly assigned the order of dietary sodium levels. All procedures were performed at both levels. Results below were after the high sodium diet. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the final urine collection which ended on Day 7.
|
|---|---|---|---|---|
|
24hr Urinary Dopamine
|
223 micrograms
Interval 179.0 to 256.0
|
236 micrograms
Interval 177.0 to 289.0
|
202 micrograms
Interval 150.0 to 258.0
|
205 micrograms
Interval 171.0 to 229.0
|
SECONDARY 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 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. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the final urine collection which ended on Day 7.
|
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. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the final urine collection which ended on Day 7.
|
Postural Tachycardia Syndrome (POTS) Participants Who Consumed Low Sodium Diet.
n=14 Participants
Patients with POTS were randomly assigned the order of dietary sodium levels. All procedures were performed at both levels. Results below were after the low sodium diet. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the final urine collection which ended on Day 7.
|
Postural Tachycardia Syndrome (POTS) Participants Who Consumed High Sodium Diet
n=14 Participants
Patients with POTS were randomly assigned the order of dietary sodium levels. All procedures were performed at both levels. Results below were after the high sodium diet. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the final urine collection which ended on Day 7.
|
|---|---|---|---|---|
|
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: Supine and upright heart rate were measured after 6 days of each dietary sodium levelPopulation: 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). Differences between supine and standing values 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. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the final urine collection which ended on Day 7.
|
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. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the final urine collection which ended on Day 7.
|
Postural Tachycardia Syndrome (POTS) Participants Who Consumed Low Sodium Diet.
n=13 Participants
Patients with POTS were randomly assigned the order of dietary sodium levels. All procedures were performed at both levels. Results below were after the low sodium diet. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the final urine collection which ended on Day 7.
|
Postural Tachycardia Syndrome (POTS) Participants Who Consumed High Sodium Diet
n=14 Participants
Patients with POTS were randomly assigned the order of dietary sodium levels. All procedures were performed at both levels. Results below were after the high sodium diet. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the final urine collection which ended on Day 7.
|
|---|---|---|---|---|
|
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
|
SECONDARY outcome
Timeframe: Upright symptoms were assessed on the 6th day of low or high sodium 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 ranging from a minimum of 0 (reflecting an absence of symptoms) to a maximum score of 10. The sum of the individual symptom scores was used to calculate orthostatic symptom burden for each participant. The lowest possible total score was 0, if a participant scored all 9 questions as 0, and the highest possible score was 90, if a participant scored all 9 questions as 10. Higher scores indicated 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. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the final urine collection which ended on Day 7.
|
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. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the final urine collection which ended on Day 7.
|
Postural Tachycardia Syndrome (POTS) Participants Who Consumed Low Sodium Diet.
n=9 Participants
Patients with POTS were randomly assigned the order of dietary sodium levels. All procedures were performed at both levels. Results below were after the low sodium diet. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the final urine collection which ended on Day 7.
|
Postural Tachycardia Syndrome (POTS) Participants Who Consumed High Sodium Diet
n=8 Participants
Patients with POTS were randomly assigned the order of dietary sodium levels. All procedures were performed at both levels. Results below were after the high sodium diet. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the final urine collection which ended on Day 7.
|
|---|---|---|---|---|
|
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
|
SECONDARY outcome
Timeframe: 24 hour collections ending on Day 2 of each diet phasePopulation: One healthy control neglected to collect urine during this time interval on low sodium diet, and a urine sample for another healthy control on high sodium diet was inadvertently not analyzed for sodium
Urinary sodium excretion will be measured every 24 hours as the participant adapts from the 150 mEq Na/day diet to the 10 and 300 mEq Na/day diets.
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. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the final urine collection which ended on Day 7.
|
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. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the final urine collection which ended on Day 7.
|
Postural Tachycardia Syndrome (POTS) Participants Who Consumed Low Sodium Diet.
n=14 Participants
Patients with POTS were randomly assigned the order of dietary sodium levels. All procedures were performed at both levels. Results below were after the low sodium diet. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the final urine collection which ended on Day 7.
|
Postural Tachycardia Syndrome (POTS) Participants Who Consumed High Sodium Diet
n=14 Participants
Patients with POTS were randomly assigned the order of dietary sodium levels. All procedures were performed at both levels. Results below were after the high sodium diet. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the final urine collection which ended on Day 7.
|
|---|---|---|---|---|
|
Urinary Sodium Following Change in Dietary Sodium Days 1-2
|
145 milliequivalents
Interval 118.0 to 183.0
|
134 milliequivalents
Interval 96.0 to 178.0
|
143 milliequivalents
Interval 103.0 to 171.0
|
160 milliequivalents
Interval 95.0 to 180.0
|
SECONDARY outcome
Timeframe: 24 hour collections ending on Day 2 of each dietary sodium phasePopulation: One healthy control neglected to collect urine during this time interval on the low sodium diet
Urinary dopamine excretion will be measured every 24 hours as the participant adapts from the 150 mEq Na/day diet to the 10 and 300 mEq Na/day diets.
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. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the final urine collection which ended on Day 7.
|
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. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the final urine collection which ended on Day 7.
|
Postural Tachycardia Syndrome (POTS) Participants Who Consumed Low Sodium Diet.
n=14 Participants
Patients with POTS were randomly assigned the order of dietary sodium levels. All procedures were performed at both levels. Results below were after the low sodium diet. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the final urine collection which ended on Day 7.
|
Postural Tachycardia Syndrome (POTS) Participants Who Consumed High Sodium Diet
n=14 Participants
Patients with POTS were randomly assigned the order of dietary sodium levels. All procedures were performed at both levels. Results below were after the high sodium diet. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the final urine collection which ended on Day 7.
|
|---|---|---|---|---|
|
Urinary Dopamine Following Change in Dietary Sodium Days1-2
|
228 micrograms
Interval 153.0 to 265.0
|
200 micrograms
Interval 141.0 to 256.0
|
207 micrograms
Interval 144.0 to 262.0
|
202 micrograms
Interval 159.0 to 228.0
|
SECONDARY outcome
Timeframe: 24 hour collections ending on Day 3 of each diet phasePopulation: 24hr urine samples were collected and analyzed for 13 healthy controls and 14 patients with POTS during both the low sodium and high sodium diet phases
Urinary sodium excretion will be measured every 24 hours as the participant adapts from the 150 mEq Na/day diet to the 10 and 300 mEq Na/day diets.
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. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the final urine collection which ended on Day 7.
|
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. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the final urine collection which ended on Day 7.
|
Postural Tachycardia Syndrome (POTS) Participants Who Consumed Low Sodium Diet.
n=14 Participants
Patients with POTS were randomly assigned the order of dietary sodium levels. All procedures were performed at both levels. Results below were after the low sodium diet. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the final urine collection which ended on Day 7.
|
Postural Tachycardia Syndrome (POTS) Participants Who Consumed High Sodium Diet
n=14 Participants
Patients with POTS were randomly assigned the order of dietary sodium levels. All procedures were performed at both levels. Results below were after the high sodium diet. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the final urine collection which ended on Day 7.
|
|---|---|---|---|---|
|
Urinary Sodium Following Change in Dietary Sodium Days 2-3
|
88.0 milliequivalents
Interval 73.1 to 97.4
|
199 milliequivalents
Interval 165.0 to 209.0
|
70.1 milliequivalents
Interval 60.2 to 84.6
|
154 milliequivalents
Interval 132.0 to 194.0
|
SECONDARY outcome
Timeframe: 24 hour collections ending on Day 4 of each diet phasePopulation: 24hr urine samples were collected and analyzed for 13 healthy controls and 14 patients with POTS during both the low sodium and high sodium diet phases
Urinary sodium excretion will be measured every 24 hours as the participant adapts from the 150 mEq Na/day diet to the 10 and 300 mEq Na/day diets.
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. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the final urine collection which ended on Day 7.
|
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. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the final urine collection which ended on Day 7.
|
Postural Tachycardia Syndrome (POTS) Participants Who Consumed Low Sodium Diet.
n=14 Participants
Patients with POTS were randomly assigned the order of dietary sodium levels. All procedures were performed at both levels. Results below were after the low sodium diet. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the final urine collection which ended on Day 7.
|
Postural Tachycardia Syndrome (POTS) Participants Who Consumed High Sodium Diet
n=14 Participants
Patients with POTS were randomly assigned the order of dietary sodium levels. All procedures were performed at both levels. Results below were after the high sodium diet. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the final urine collection which ended on Day 7.
|
|---|---|---|---|---|
|
Urinary Sodium Following Change in Dietary Sodium Days 3-4
|
32.7 milliequivalents
Interval 22.6 to 64.7
|
230 milliequivalents
Interval 177.0 to 261.0
|
28.9 milliequivalents
Interval 19.4 to 38.9
|
222 milliequivalents
Interval 203.0 to 265.0
|
SECONDARY outcome
Timeframe: 24 hour collections ending on Day 5 of each diet phasePopulation: The urine sample for 1 patient with POTS was collected during this time interval during high sodium diet but it was inadvertently not analyzed.
Urinary sodium excretion will be measured every 24 hours as the participant adapts from the 150 mEq Na/day diet to the 10 and 300 mEq Na/day diets
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. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the final urine collection which ended on Day 7.
|
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. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the final urine collection which ended on Day 7.
|
Postural Tachycardia Syndrome (POTS) Participants Who Consumed Low Sodium Diet.
n=14 Participants
Patients with POTS were randomly assigned the order of dietary sodium levels. All procedures were performed at both levels. Results below were after the low sodium diet. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the final urine collection which ended on Day 7.
|
Postural Tachycardia Syndrome (POTS) Participants Who Consumed High Sodium Diet
n=13 Participants
Patients with POTS were randomly assigned the order of dietary sodium levels. All procedures were performed at both levels. Results below were after the high sodium diet. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the final urine collection which ended on Day 7.
|
|---|---|---|---|---|
|
Urinary Sodium Following Change in Dietary Sodium Days 4-5
|
17.3 milliequivalents
Interval 14.1 to 28.7
|
216 milliequivalents
Interval 182.0 to 249.0
|
21.6 milliequivalents
Interval 17.6 to 26.7
|
264 milliequivalents
Interval 258.0 to 309.0
|
SECONDARY outcome
Timeframe: 24 hour collections ending on Day 6 of each diet phasePopulation: 24hr urine samples were collected and analyzed for 13 healthy controls and 14 patients with POTS during both the low sodium and high sodium diet phases
Urinary sodium excretion will be measured every 24 hours as the participant adapts from the 150 mEq Na/day diet to the 10 and 300 mEq Na/day diets.
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. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the final urine collection which ended on Day 7.
|
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. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the final urine collection which ended on Day 7.
|
Postural Tachycardia Syndrome (POTS) Participants Who Consumed Low Sodium Diet.
n=14 Participants
Patients with POTS were randomly assigned the order of dietary sodium levels. All procedures were performed at both levels. Results below were after the low sodium diet. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the final urine collection which ended on Day 7.
|
Postural Tachycardia Syndrome (POTS) Participants Who Consumed High Sodium Diet
n=14 Participants
Patients with POTS were randomly assigned the order of dietary sodium levels. All procedures were performed at both levels. Results below were after the high sodium diet. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the final urine collection which ended on Day 7.
|
|---|---|---|---|---|
|
Urinary Sodium Following Change in Dietary Sodium Days 5-6
|
21.6 milliequivalents
Interval 14.6 to 31.6
|
260 milliequivalents
Interval 187.0 to 293.0
|
18.2 milliequivalents
Interval 11.6 to 25.8
|
242 milliequivalents
Interval 201.0 to 286.0
|
SECONDARY outcome
Timeframe: 24 hour collections ending on Day 3 of each dietary sodium phasePopulation: The urine sample for 1 healthy control was collected during this interval of the low sodium diet phase, but the sample was inadvertently sent to the wrong lab for analysis
Urinary dopamine excretion will be measured every 24 hours as the participant adapts from the 150 mEq Na/day diet to the 10 and 300 mEq Na/day diets.
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. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the final urine collection which ended on Day 7.
|
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. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the final urine collection which ended on Day 7.
|
Postural Tachycardia Syndrome (POTS) Participants Who Consumed Low Sodium Diet.
n=14 Participants
Patients with POTS were randomly assigned the order of dietary sodium levels. All procedures were performed at both levels. Results below were after the low sodium diet. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the final urine collection which ended on Day 7.
|
Postural Tachycardia Syndrome (POTS) Participants Who Consumed High Sodium Diet
n=14 Participants
Patients with POTS were randomly assigned the order of dietary sodium levels. All procedures were performed at both levels. Results below were after the high sodium diet. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the final urine collection which ended on Day 7.
|
|---|---|---|---|---|
|
Urinary Dopamine Following Change in Dietary Sodium Days 2-3
|
183 micrograms
Interval 138.0 to 271.0
|
185 micrograms
Interval 126.0 to 250.0
|
205 micrograms
Interval 158.0 to 236.0
|
171 micrograms
Interval 144.0 to 226.0
|
SECONDARY outcome
Timeframe: 24 hour collections ending on Day 4 of each dietary sodium phasePopulation: The urine sample for 1 healthy control was collected during this interval of the low sodium diet phase, but the sample was inadvertently sent to the wrong lab for analysis
Urinary dopamine excretion will be measured every 24 hours as the participant adapts from the 150 mEq Na/day diet to the 10 and 300 mEq Na/day diets.
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. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the final urine collection which ended on Day 7.
|
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. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the final urine collection which ended on Day 7.
|
Postural Tachycardia Syndrome (POTS) Participants Who Consumed Low Sodium Diet.
n=14 Participants
Patients with POTS were randomly assigned the order of dietary sodium levels. All procedures were performed at both levels. Results below were after the low sodium diet. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the final urine collection which ended on Day 7.
|
Postural Tachycardia Syndrome (POTS) Participants Who Consumed High Sodium Diet
n=14 Participants
Patients with POTS were randomly assigned the order of dietary sodium levels. All procedures were performed at both levels. Results below were after the high sodium diet. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the final urine collection which ended on Day 7.
|
|---|---|---|---|---|
|
Urinary Dopamine Following Change in Dietary Sodium Days 3-4
|
222 micrograms
Interval 152.0 to 259.0
|
193 micrograms
Interval 128.0 to 244.0
|
203 micrograms
Interval 154.0 to 235.0
|
177 micrograms
Interval 136.0 to 211.0
|
SECONDARY outcome
Timeframe: 24 hour collections ending on Day 5 of each dietary sodium phasePopulation: Urine was collected and analyzed for 13 healthy controls and 14 patients with POTS during this time interval of the low sodium and high sodium diets
Urinary dopamine excretion will be measured every 24 hours as the participant adapts from the 150 mEq Na/day diet to the 10 and 300 mEq Na/day diets.
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. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the final urine collection which ended on Day 7.
|
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. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the final urine collection which ended on Day 7.
|
Postural Tachycardia Syndrome (POTS) Participants Who Consumed Low Sodium Diet.
n=14 Participants
Patients with POTS were randomly assigned the order of dietary sodium levels. All procedures were performed at both levels. Results below were after the low sodium diet. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the final urine collection which ended on Day 7.
|
Postural Tachycardia Syndrome (POTS) Participants Who Consumed High Sodium Diet
n=14 Participants
Patients with POTS were randomly assigned the order of dietary sodium levels. All procedures were performed at both levels. Results below were after the high sodium diet. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the final urine collection which ended on Day 7.
|
|---|---|---|---|---|
|
Urinary Dopamine Following Change in Dietary Sodium Days 4-5
|
213 micrograms
Interval 145.0 to 253.0
|
202 micrograms
Interval 150.0 to 261.0
|
205 micrograms
Interval 145.0 to 257.0
|
214 micrograms
Interval 189.0 to 280.0
|
SECONDARY outcome
Timeframe: 24 hour collections ending on Day 6 of each dietary sodium phasePopulation: Urine was collected and analyzed for 13 healthy controls and 14 patients with POTS during this time interval of the low sodium and high sodium diets
Urinary dopamine excretion will be measured every 24 hours as the participant adapts from the 150 mEq Na/day diet to the 10 and 300 mEq Na/day diets.
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. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the final urine collection which ended on Day 7.
|
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. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the final urine collection which ended on Day 7.
|
Postural Tachycardia Syndrome (POTS) Participants Who Consumed Low Sodium Diet.
n=14 Participants
Patients with POTS were randomly assigned the order of dietary sodium levels. All procedures were performed at both levels. Results below were after the low sodium diet. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the final urine collection which ended on Day 7.
|
Postural Tachycardia Syndrome (POTS) Participants Who Consumed High Sodium Diet
n=14 Participants
Patients with POTS were randomly assigned the order of dietary sodium levels. All procedures were performed at both levels. Results below were after the high sodium diet. Urine was collected daily for a 24hr period ending at approximately 8am. These results are for the final urine collection which ended on Day 7.
|
|---|---|---|---|---|
|
Urinary Dopamine Following Change in Dietary Sodium Days 5-6
|
227 micrograms
Interval 160.0 to 258.0
|
210 micrograms
Interval 169.0 to 263.0
|
211 micrograms
Interval 156.0 to 263.0
|
199 micrograms
Interval 168.0 to 251.0
|
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 with POTS were randomly assigned the order of dietary sodium levels. All procedures were performed at both 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 with POTS were randomly assigned the order of dietary sodium levels. All procedures were performed at both 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