Trial Outcomes & Findings for Study of Vitamin D and Uric Acid Lowering on Kidney and Blood Vessel Function (NCT NCT01320722)
NCT ID: NCT01320722
Last Updated: 2017-06-29
Results Overview
Change in RPF in response to captopril is a measure of the vasodilator effect from inhibiting angiotensin II (AngII)- mediated vascular tone and therefore the degree of kidney specific Renin Angiotensin System (RAS) activity. Participants consumed a high sodium diet 3 days prior to the test. Following an 8 hour fast, participants remained in a supine (lying down) position and had an intravenous (IV) catheter inserted in each arm, one for infusion and one for blood collection. An 8 milligrams (mg)/kilogram(kg) loading dose of para-aminohippuric acid (PAH) was given, immediately followed by a continuous PAH infusion at 12 mg/minute. After 60 minutes a single dose of 25 mg of captopril was administered. Three pre-captopril measurements and three post-captopril measurements of RPF were made. RPF was normalized to body surface area of 1.73 meters squared (m\^2). The change in RPF was calculated as post-captopril RPF- pre-captopril RPF.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
242 participants
Primary outcome timeframe
Week 8 (pre and post captopril)
Results posted on
2017-06-29
Participant Flow
Participant milestones
| Measure |
Vitamin D
Vitamin D ergocalciferol 50,000 unit soft gel capsule once per week for 8 weeks.
|
Placebo- Vitamin D
Placebo soft gel once per week for 8 weeks.
|
Probenecid
Probenecid 500 mg tablet once per day for 4 weeks, then either 500 mg tablet once per day for 4 weeks or 1000 mg once per day for 4 weeks (8 weeks total).
|
Allopurinol
Allopurinol 300 mg tablet once per day for 4 weeks then either 300 mg once per day or 600 mg once per day for 4 weeks (8 weeks total).
|
Placebo- Uric Acid
Placebo tablet once per day for 4 weeks then twice per day for 4 weeks (eight weeks total).
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
46
|
47
|
47
|
49
|
53
|
|
Overall Study
Received Intervention
|
43
|
45
|
46
|
48
|
51
|
|
Overall Study
COMPLETED
|
43
|
41
|
40
|
35
|
45
|
|
Overall Study
NOT COMPLETED
|
3
|
6
|
7
|
14
|
8
|
Reasons for withdrawal
| Measure |
Vitamin D
Vitamin D ergocalciferol 50,000 unit soft gel capsule once per week for 8 weeks.
|
Placebo- Vitamin D
Placebo soft gel once per week for 8 weeks.
|
Probenecid
Probenecid 500 mg tablet once per day for 4 weeks, then either 500 mg tablet once per day for 4 weeks or 1000 mg once per day for 4 weeks (8 weeks total).
|
Allopurinol
Allopurinol 300 mg tablet once per day for 4 weeks then either 300 mg once per day or 600 mg once per day for 4 weeks (8 weeks total).
|
Placebo- Uric Acid
Placebo tablet once per day for 4 weeks then twice per day for 4 weeks (eight weeks total).
|
|---|---|---|---|---|---|
|
Overall Study
Did not Receive Intervention
|
3
|
2
|
1
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
1
|
3
|
|
Overall Study
Not Available for the 8 Week Visit
|
0
|
3
|
0
|
0
|
0
|
|
Overall Study
Participant Developed a Rash
|
0
|
0
|
2
|
1
|
1
|
|
Overall Study
Non-compliant with Medication
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
3
|
6
|
0
|
|
Overall Study
Not Compliant with Study Procedures
|
0
|
0
|
0
|
4
|
0
|
|
Overall Study
Pregnancy
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Started an Exclusionary Medication
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrew due to Health Condition
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
All randomized participants in the Vitamin D arms.
Baseline characteristics by cohort
| Measure |
Vitamin D
n=46 Participants
Vitamin D ergocalciferol 50,000 unit soft gel capsule once per week for 8 weeks.
|
Placebo- Vitamin D
n=47 Participants
Placebo soft gel once per week for 8 weeks.
|
Probenecid
n=47 Participants
Probenecid 500 mg tablet once per day for 4 weeks, then either 500 mg tablet once per day for 4 weeks or 1000 mg once per day for 4 weeks (8 weeks total).
|
Allopurinol
n=49 Participants
Allopurinol 300 mg tablet once per day for 4 weeks then either 300 mg once per day or 600 mg once per day for 4 weeks (8 weeks total).
|
Placebo- Uric Acid
n=53 Participants
Placebo tablet once per day for 4 weeks then twice per day for 4 weeks (eight weeks total).
|
Total
n=242 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
39 years
STANDARD_DEVIATION 13 • n=46 Participants • All randomized participants in the Vitamin D arms.
|
35 years
STANDARD_DEVIATION 11 • n=47 Participants • All randomized participants in the Vitamin D arms.
|
37 years
STANDARD_DEVIATION 14 • n=47 Participants • All randomized participants in the Uric Acid arms.
|
43 years
STANDARD_DEVIATION 12.5 • n=49 Participants • All randomized participants in the Uric Acid arms.
|
41 years
STANDARD_DEVIATION 14 • n=53 Participants • All randomized participants in the Uric Acid arms.
|
41 years
STANDARD_DEVIATION 14 • n=149 Participants • All randomized participants in the Uric Acid arms.
|
|
Sex: Female, Male
Female
|
31 Participants
n=46 Participants
|
31 Participants
n=47 Participants
|
23 Participants
n=47 Participants
|
24 Participants
n=49 Participants
|
28 Participants
n=53 Participants
|
137 Participants
n=242 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=46 Participants
|
16 Participants
n=47 Participants
|
24 Participants
n=47 Participants
|
25 Participants
n=49 Participants
|
25 Participants
n=53 Participants
|
105 Participants
n=242 Participants
|
|
Change in Renal Plasma Flow (RPF) in Response to Captopril [Vitamin D]
|
33.9 milliliters(mL)/minute(min) per 1.73 m^2
STANDARD_DEVIATION 56.1 • n=43 Participants • All randomized participants in the Vitamin D arms with data available for RPF.
|
37.3 milliliters(mL)/minute(min) per 1.73 m^2
STANDARD_DEVIATION 46.9 • n=41 Participants • All randomized participants in the Vitamin D arms with data available for RPF.
|
—
|
—
|
—
|
35.6 milliliters(mL)/minute(min) per 1.73 m^2
STANDARD_DEVIATION 50.0 • n=84 Participants • All randomized participants in the Vitamin D arms with data available for RPF.
|
|
Change in RPF in Response to Captopril [Uric Acid]
|
—
|
—
|
38 mL/min per 1.73 m^2
STANDARD_DEVIATION 46.0 • n=40 Participants • All randomized participants in the Uric Acid arms with data available for RPF.
|
41 mL/min per 1.73 m^2
STANDARD_DEVIATION 32.2 • n=45 Participants • All randomized participants in the Uric Acid arms with data available for RPF.
|
30 mL/min per 1.73 m^2
STANDARD_DEVIATION 35.5 • n=53 Participants • All randomized participants in the Uric Acid arms with data available for RPF.
|
36.3 mL/min per 1.73 m^2
STANDARD_DEVIATION 38.7 • n=138 Participants • All randomized participants in the Uric Acid arms with data available for RPF.
|
|
Plasma Renin Activity (PRA) [Vitamin D]
|
0.34 nanograms (ng)/mL per hour
STANDARD_DEVIATION 0.37 • n=43 Participants • All randomized participants in the Vitamin D arms with data available for PRA.
|
0.42 nanograms (ng)/mL per hour
STANDARD_DEVIATION 0.44 • n=41 Participants • All randomized participants in the Vitamin D arms with data available for PRA.
|
—
|
—
|
—
|
0.38 nanograms (ng)/mL per hour
STANDARD_DEVIATION 0.40 • n=84 Participants • All randomized participants in the Vitamin D arms with data available for PRA.
|
|
Plasma Renin Activity (PRA) [Uric Acid]
|
—
|
—
|
0.3 ng/mL
STANDARD_DEVIATION 0.52 • n=39 Participants • All randomized participants in the Uric Acid arms with data available for PRA.
|
0.3 ng/mL
STANDARD_DEVIATION 0.33 • n=35 Participants • All randomized participants in the Uric Acid arms with data available for PRA.
|
0.2 ng/mL
STANDARD_DEVIATION 0.33 • n=43 Participants • All randomized participants in the Uric Acid arms with data available for PRA.
|
0.27 ng/mL
STANDARD_DEVIATION 0.40 • n=117 Participants • All randomized participants in the Uric Acid arms with data available for PRA.
|
|
Angiotensin II Concentration (ATII) [Vitamin D]
|
19.9 picogram(pg)/mL
STANDARD_DEVIATION 5.9 • n=43 Participants • All randomized participants in the Vitamin D arms with data available for ATII.
|
19.9 picogram(pg)/mL
STANDARD_DEVIATION 4.5 • n=41 Participants • All randomized participants in the Vitamin D arms with data available for ATII.
|
—
|
—
|
—
|
19.9 picogram(pg)/mL
STANDARD_DEVIATION 5.0 • n=84 Participants • All randomized participants in the Vitamin D arms with data available for ATII.
|
|
Angiotensin II Concentration (ATII) [Uric Acid]
|
—
|
—
|
19.6 pg/mL
STANDARD_DEVIATION 5.0 • n=40 Participants • All randomized participants in the Uric Acid arms with data available for ATII.
|
18.9 pg/mL
STANDARD_DEVIATION 4.0 • n=34 Participants • All randomized participants in the Uric Acid arms with data available for ATII.
|
18.8 pg/mL
STANDARD_DEVIATION 4.8 • n=45 Participants • All randomized participants in the Uric Acid arms with data available for ATII.
|
19.1 pg/mL
STANDARD_DEVIATION 4.6 • n=119 Participants • All randomized participants in the Uric Acid arms with data available for ATII.
|
PRIMARY outcome
Timeframe: Week 8 (pre and post captopril)Population: All randomized enrolled participants included in the analysis.
Change in RPF in response to captopril is a measure of the vasodilator effect from inhibiting angiotensin II (AngII)- mediated vascular tone and therefore the degree of kidney specific Renin Angiotensin System (RAS) activity. Participants consumed a high sodium diet 3 days prior to the test. Following an 8 hour fast, participants remained in a supine (lying down) position and had an intravenous (IV) catheter inserted in each arm, one for infusion and one for blood collection. An 8 milligrams (mg)/kilogram(kg) loading dose of para-aminohippuric acid (PAH) was given, immediately followed by a continuous PAH infusion at 12 mg/minute. After 60 minutes a single dose of 25 mg of captopril was administered. Three pre-captopril measurements and three post-captopril measurements of RPF were made. RPF was normalized to body surface area of 1.73 meters squared (m\^2). The change in RPF was calculated as post-captopril RPF- pre-captopril RPF.
Outcome measures
| Measure |
Vitamin D
n=43 Participants
Vitamin D ergocalciferol 50,000 unit soft gel capsule once per week for 8 weeks.
|
Placebo- Vitamin D
n=41 Participants
Placebo soft gel once per week for 8 weeks.
|
Placebo- Uric Acid
Placebo tablet once per day for 4 weeks then twice per day for 4 weeks (eight weeks total).
|
Allopurinol
Allopurinol 300 mg tablet once per day for 4 weeks then either 300 mg once per day or 600 mg once per day for 4 weeks (8 weeks total).
|
Placebo- Uric Acid
Placebo tablet once per day for 4 weeks then twice per day for 4 weeks (eight weeks total).
|
|---|---|---|---|---|---|
|
Change in Renal Plasma Flow (RPF) in Response to Captopril in High Sodium Balance [Vitamin D]
|
35.7 mL/min per 1.73 m^2
Standard Deviation 47.7
|
35.9 mL/min per 1.73 m^2
Standard Deviation 26.2
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Week 8Population: All randomized enrolled participants included in the analysis.
PRA is a measure of systemic renin angiotensin system (RAS) activation. Blood was collected and plasma PRA was analyzed using a competitive binding radioimmunoassay (RIA) laboratory test.
Outcome measures
| Measure |
Vitamin D
n=43 Participants
Vitamin D ergocalciferol 50,000 unit soft gel capsule once per week for 8 weeks.
|
Placebo- Vitamin D
n=41 Participants
Placebo soft gel once per week for 8 weeks.
|
Placebo- Uric Acid
Placebo tablet once per day for 4 weeks then twice per day for 4 weeks (eight weeks total).
|
Allopurinol
Allopurinol 300 mg tablet once per day for 4 weeks then either 300 mg once per day or 600 mg once per day for 4 weeks (8 weeks total).
|
Placebo- Uric Acid
Placebo tablet once per day for 4 weeks then twice per day for 4 weeks (eight weeks total).
|
|---|---|---|---|---|---|
|
Plasma Renin Activity (PRA) [Vitamin D]
|
0.36 ng/mL per hour
Standard Deviation 0.44
|
0.44 ng/mL per hour
Standard Deviation 0.8
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Week 8Population: All randomized enrolled participants included in the analysis.
ATII concentration is a measure of systemic renin angiotensin system (RAS) activation. Blood was collected and plasma ATII was analyzed using a double-antibody radioimmunoassay (RIA) laboratory test.
Outcome measures
| Measure |
Vitamin D
n=43 Participants
Vitamin D ergocalciferol 50,000 unit soft gel capsule once per week for 8 weeks.
|
Placebo- Vitamin D
n=41 Participants
Placebo soft gel once per week for 8 weeks.
|
Placebo- Uric Acid
Placebo tablet once per day for 4 weeks then twice per day for 4 weeks (eight weeks total).
|
Allopurinol
Allopurinol 300 mg tablet once per day for 4 weeks then either 300 mg once per day or 600 mg once per day for 4 weeks (8 weeks total).
|
Placebo- Uric Acid
Placebo tablet once per day for 4 weeks then twice per day for 4 weeks (eight weeks total).
|
|---|---|---|---|---|---|
|
Angiotensin II (ATII) Concentration [Vitamin D]
|
19.5 pg/mL
Standard Deviation 4.4
|
19.7 pg/mL
Standard Deviation 7.1
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Week 8 (pre and post captopril)Population: All randomized enrolled participants with data available for analysis.
RPF in response to captopril iis a measure of the vasodilator effect from inhibiting angiotensin II (AngII)- mediated vascular tone and therefore the degree of kidney specific Renin Angiotensin System (RAS) activity. Participants consumed a high sodium diet 3 days prior to the test. Following an 8 hour fast, participants remained in a supine (lying down) position and had an intravenous (IV) catheter inserted in each arm, one for infusion and one for blood collection. An 8 milligrams (mg)/kilogram(kg) loading dose of para-aminohippuric acid (PAH) was given, immediately followed by a continuous PAH infusion at 12 mg/minute. After 60 minutes a single dose of 25 mg of captopril was administered. Three pre-captopril measurements and three post-captopril measurements of RPF were made. RPF was normalized to body surface area of 1.73 meters squared (m\^2). The change in RPF was calculated as post-captopril RPF- pre-captopril RPF.
Outcome measures
| Measure |
Vitamin D
n=40 Participants
Vitamin D ergocalciferol 50,000 unit soft gel capsule once per week for 8 weeks.
|
Placebo- Vitamin D
n=34 Participants
Placebo soft gel once per week for 8 weeks.
|
Placebo- Uric Acid
n=45 Participants
Placebo tablet once per day for 4 weeks then twice per day for 4 weeks (eight weeks total).
|
Allopurinol
Allopurinol 300 mg tablet once per day for 4 weeks then either 300 mg once per day or 600 mg once per day for 4 weeks (8 weeks total).
|
Placebo- Uric Acid
Placebo tablet once per day for 4 weeks then twice per day for 4 weeks (eight weeks total).
|
|---|---|---|---|---|---|
|
Change in Renal Plasma Flow (RPF) Response to Captopril in High Sodium Balance [Uric Acid]
|
33 mL/min per 1.73 m^2
Interval 12.0 to 72.0
|
36 mL/min per 1.73 m^2
Interval 17.0 to 55.0
|
30 mL/min per 1.73 m^2
Interval -1.0 to 48.0
|
—
|
—
|
PRIMARY outcome
Timeframe: Week 8Population: All randomized enrolled participants with data available for analysis.
PRA is a measure of systemic renin angiotensin system (RAS) activation. Blood was collected and plasma PRA was analyzed using a competitive binding radioimmunoassay (RIA) laboratory test.
Outcome measures
| Measure |
Vitamin D
n=40 Participants
Vitamin D ergocalciferol 50,000 unit soft gel capsule once per week for 8 weeks.
|
Placebo- Vitamin D
n=33 Participants
Placebo soft gel once per week for 8 weeks.
|
Placebo- Uric Acid
n=44 Participants
Placebo tablet once per day for 4 weeks then twice per day for 4 weeks (eight weeks total).
|
Allopurinol
Allopurinol 300 mg tablet once per day for 4 weeks then either 300 mg once per day or 600 mg once per day for 4 weeks (8 weeks total).
|
Placebo- Uric Acid
Placebo tablet once per day for 4 weeks then twice per day for 4 weeks (eight weeks total).
|
|---|---|---|---|---|---|
|
Plasma Renin Activity (PRA) [Uric Acid]
|
0.4 ng/mL per hour
Interval 0.2 to 0.7
|
0.3 ng/mL per hour
Interval 0.2 to 0.5
|
0.2 ng/mL per hour
Interval 0.1 to 0.6
|
—
|
—
|
PRIMARY outcome
Timeframe: Week 8Population: All randomized enrolled participants with data available for analysis.
ATII concentration is a measure of systemic renin angiotensin system (RAS) activation. Blood was collected and plasma ATII was analyzed using a double-antibody radioimmunoassay (RIA) laboratory test.
Outcome measures
| Measure |
Vitamin D
n=39 Participants
Vitamin D ergocalciferol 50,000 unit soft gel capsule once per week for 8 weeks.
|
Placebo- Vitamin D
n=34 Participants
Placebo soft gel once per week for 8 weeks.
|
Placebo- Uric Acid
n=45 Participants
Placebo tablet once per day for 4 weeks then twice per day for 4 weeks (eight weeks total).
|
Allopurinol
Allopurinol 300 mg tablet once per day for 4 weeks then either 300 mg once per day or 600 mg once per day for 4 weeks (8 weeks total).
|
Placebo- Uric Acid
Placebo tablet once per day for 4 weeks then twice per day for 4 weeks (eight weeks total).
|
|---|---|---|---|---|---|
|
Angiotensin II (ATII) Concentration [Uric Acid]
|
20.3 pg/mL
Interval 18.5 to 22.7
|
21.4 pg/mL
Interval 18.2 to 24.4
|
19.1 pg/mL
Interval 17.0 to 21.5
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 8 (pre and post ischaemic stimulus)Population: All randomized enrolled participants.
Endothelial function was assessed by EDV using brachial artery ultrasonography. Measurements of brachial artery diameter were made under basal conditions and reactive hyperemia following ischaemic stimulus. A blood pressure cuff on the forearm was pumped up for 5 minutes then released. Images were taken at baseline and after reactive hyperemia (increased blood flow). The maximum diameter was determined by the investigator. Change in EDV was expressed as a percent of brachial luminal diameter calculated as post-ischaemic brachial artery diameter - pre-ischaemic brachial artery diameter/pre-ischaemic brachial artery diameter \* 100.
Outcome measures
| Measure |
Vitamin D
n=46 Participants
Vitamin D ergocalciferol 50,000 unit soft gel capsule once per week for 8 weeks.
|
Placebo- Vitamin D
n=47 Participants
Placebo soft gel once per week for 8 weeks.
|
Placebo- Uric Acid
n=47 Participants
Placebo tablet once per day for 4 weeks then twice per day for 4 weeks (eight weeks total).
|
Allopurinol
n=49 Participants
Allopurinol 300 mg tablet once per day for 4 weeks then either 300 mg once per day or 600 mg once per day for 4 weeks (8 weeks total).
|
Placebo- Uric Acid
n=53 Participants
Placebo tablet once per day for 4 weeks then twice per day for 4 weeks (eight weeks total).
|
|---|---|---|---|---|---|
|
Change in Endothelium-Dependent Vasodilation (EDV)
Baseline
|
6.3 percent of brachial luminal diameter
Standard Deviation 3.6
|
7.9 percent of brachial luminal diameter
Standard Deviation 4.7
|
7.4 percent of brachial luminal diameter
Standard Deviation 5.1
|
7.6 percent of brachial luminal diameter
Standard Deviation 6.0
|
6.5 percent of brachial luminal diameter
Standard Deviation 3.8
|
|
Change in Endothelium-Dependent Vasodilation (EDV)
Week 8
|
6.1 percent of brachial luminal diameter
Standard Deviation 4.6
|
6.8 percent of brachial luminal diameter
Standard Deviation 4.7
|
8.3 percent of brachial luminal diameter
Standard Deviation 5.1
|
6.2 percent of brachial luminal diameter
Standard Deviation 4.8
|
7.1 percent of brachial luminal diameter
Standard Deviation 4.9
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: All randomized enrolled participants with complete 24-hour ABP data available for analysis.
A 24-hour mean ambulatory blood pressure was monitored using a 24 hour ABP device. The ABP device is a small box that is worn on the belt or pant/skirt line with a line that connect under the clothing to the cuff on the upper arm. Blood Pressure was recorded every 30 minutes during the day and every 60 minutes during the night for 24 hours.
Outcome measures
| Measure |
Vitamin D
n=29 Participants
Vitamin D ergocalciferol 50,000 unit soft gel capsule once per week for 8 weeks.
|
Placebo- Vitamin D
n=27 Participants
Placebo soft gel once per week for 8 weeks.
|
Placebo- Uric Acid
n=25 Participants
Placebo tablet once per day for 4 weeks then twice per day for 4 weeks (eight weeks total).
|
Allopurinol
n=27 Participants
Allopurinol 300 mg tablet once per day for 4 weeks then either 300 mg once per day or 600 mg once per day for 4 weeks (8 weeks total).
|
Placebo- Uric Acid
n=30 Participants
Placebo tablet once per day for 4 weeks then twice per day for 4 weeks (eight weeks total).
|
|---|---|---|---|---|---|
|
Mean 24-Hour Ambulatory Blood Pressure (ABP)
Overall Systolic Blood Pressure (SBP), Baseline
|
120.4 mmHg
Standard Deviation 10.2
|
123.7 mmHg
Standard Deviation 7.6
|
126.9 mmHg
Standard Deviation 10.2
|
124.1 mmHg
Standard Deviation 8.8
|
122.4 mmHg
Standard Deviation 9.7
|
|
Mean 24-Hour Ambulatory Blood Pressure (ABP)
Overall Diastolic Blood Pressure (DBP), Baseline
|
71.6 mmHg
Standard Deviation 6.4
|
73.7 mmHg
Standard Deviation 5.8
|
73.3 mmHg
Standard Deviation 7.8
|
72.1 mmHg
Standard Deviation 7.1
|
71.9 mmHg
Standard Deviation 7.4
|
|
Mean 24-Hour Ambulatory Blood Pressure (ABP)
Awake SBP, Baseline
|
122.4 mmHg
Standard Deviation 10.9
|
126.4 mmHg
Standard Deviation 7.4
|
130.0 mmHg
Standard Deviation 9.2
|
126.7 mmHg
Standard Deviation 8.4
|
125.5 mmHg
Standard Deviation 9.0
|
|
Mean 24-Hour Ambulatory Blood Pressure (ABP)
Asleep SBP, Baseline
|
113.9 mmHg
Standard Deviation 11.0
|
116.5 mmHg
Standard Deviation 8.7
|
119.2 mmHg
Standard Deviation 12.4
|
117.1 mmHg
Standard Deviation 10.0
|
113.9 mmHg
Standard Deviation 12.2
|
|
Mean 24-Hour Ambulatory Blood Pressure (ABP)
Overall SBP, Week 8
|
121.6 mmHg
Standard Deviation 8.3
|
124.7 mmHg
Standard Deviation 9.6
|
125.2 mmHg
Standard Deviation 9.1
|
123.7 mmHg
Standard Deviation 9.4
|
122.9 mmHg
Standard Deviation 9.5
|
|
Mean 24-Hour Ambulatory Blood Pressure (ABP)
Overall DBP, Week 8
|
72.0 mmHg
Standard Deviation 5.6
|
74.7 mmHg
Standard Deviation 7.2
|
73.8 mmHg
Standard Deviation 6.9
|
72.0 mmHg
Standard Deviation 6.5
|
72.6 mmHg
Standard Deviation 6.2
|
|
Mean 24-Hour Ambulatory Blood Pressure (ABP)
Awake SBP, Week 8
|
124.2 mmHg
Standard Deviation 9.1
|
127.6 mmHg
Standard Deviation 9.2
|
128.1 mmHg
Standard Deviation 9.3
|
125.1 mmHg
Standard Deviation 9.6
|
124.9 mmHg
Standard Deviation 10.1
|
|
Mean 24-Hour Ambulatory Blood Pressure (ABP)
Asleep SBP, Week 8
|
114.7 mmHg
Standard Deviation 8.1
|
117.4 mmHg
Standard Deviation 11.4
|
116.2 mmHg
Standard Deviation 9.6
|
118.6 mmHg
Standard Deviation 11.7
|
116.2 mmHg
Standard Deviation 10.5
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: All randomized enrolled participants with complete 24-hour ABP data available for analysis.
A 24-hour mean ambulatory blood pressure was monitored using a 24 hour ABP device. The ABP device is a small box that is worn on the belt or pant/skirt line with a line that connect under the clothing to the cuff on the upper arm. Blood Pressure was recorded every 30 minutes during the day and every 60 minutes during the night for 24 hours. Nocturnal dipping is the percent change lower between the daytime and nighttime values.
Outcome measures
| Measure |
Vitamin D
n=29 Participants
Vitamin D ergocalciferol 50,000 unit soft gel capsule once per week for 8 weeks.
|
Placebo- Vitamin D
n=27 Participants
Placebo soft gel once per week for 8 weeks.
|
Placebo- Uric Acid
n=25 Participants
Placebo tablet once per day for 4 weeks then twice per day for 4 weeks (eight weeks total).
|
Allopurinol
n=27 Participants
Allopurinol 300 mg tablet once per day for 4 weeks then either 300 mg once per day or 600 mg once per day for 4 weeks (8 weeks total).
|
Placebo- Uric Acid
n=30 Participants
Placebo tablet once per day for 4 weeks then twice per day for 4 weeks (eight weeks total).
|
|---|---|---|---|---|---|
|
Mean 24-Hour Ambulatory Blood Pressure (ABP) Nocturnal Dipping
Baseline
|
7.3 percent change
Standard Deviation 6.3
|
7.8 percent change
Standard Deviation 5.1
|
8.4 percent change
Standard Deviation 6.8
|
7.5 percent change
Standard Deviation 5.3
|
9.4 percent change
Standard Deviation 6.2
|
|
Mean 24-Hour Ambulatory Blood Pressure (ABP) Nocturnal Dipping
Week 8
|
7.5 percent change
Standard Deviation 5.7
|
8.1 percent change
Standard Deviation 6.0
|
9.2 percent change
Standard Deviation 6.1
|
5.2 percent change
Standard Deviation 7.1
|
6.9 percent change
Standard Deviation 6.2
|
Adverse Events
Vitamin D
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo- Vitamin D
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Probenecid
Serious events: 4 serious events
Other events: 16 other events
Deaths: 0 deaths
Allopurinol
Serious events: 6 serious events
Other events: 36 other events
Deaths: 0 deaths
Placebo- Uric Acid
Serious events: 2 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vitamin D
n=43 participants at risk
Vitamin D ergocalciferol 50,000 unit soft gel capsule once per week for 8 weeks.
|
Placebo- Vitamin D
n=45 participants at risk
Placebo soft gel once per week for 8 weeks.
|
Probenecid
n=46 participants at risk
Probenecid 500 mg tablet once per day for 4 weeks, then either 500 mg tablet once per day for 4 weeks or 1000 mg once per day for 4 weeks (8 weeks total).
|
Allopurinol
n=48 participants at risk
Allopurinol 300 mg tablet once per day for 4 weeks then either 300 mg once per day or 600 mg once per day for 4 weeks (8 weeks total).
|
Placebo- Uric Acid
n=51 participants at risk
Placebo tablet once per day for 4 weeks then twice per day for 4 weeks (eight weeks total).
|
|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/43
All randomized participants who received study intervention.
|
0.00%
0/45
All randomized participants who received study intervention.
|
4.3%
2/46
All randomized participants who received study intervention.
|
2.1%
1/48
All randomized participants who received study intervention.
|
2.0%
1/51
All randomized participants who received study intervention.
|
|
Investigations
Elevated creatinine
|
0.00%
0/43
All randomized participants who received study intervention.
|
0.00%
0/45
All randomized participants who received study intervention.
|
2.2%
1/46
All randomized participants who received study intervention.
|
6.2%
3/48
All randomized participants who received study intervention.
|
0.00%
0/51
All randomized participants who received study intervention.
|
|
Investigations
Elevated liver enzymes
|
0.00%
0/43
All randomized participants who received study intervention.
|
0.00%
0/45
All randomized participants who received study intervention.
|
0.00%
0/46
All randomized participants who received study intervention.
|
6.2%
3/48
All randomized participants who received study intervention.
|
2.0%
1/51
All randomized participants who received study intervention.
|
|
Investigations
Decreased hematocrit
|
0.00%
0/43
All randomized participants who received study intervention.
|
0.00%
0/45
All randomized participants who received study intervention.
|
2.2%
1/46
All randomized participants who received study intervention.
|
0.00%
0/48
All randomized participants who received study intervention.
|
0.00%
0/51
All randomized participants who received study intervention.
|
Other adverse events
| Measure |
Vitamin D
n=43 participants at risk
Vitamin D ergocalciferol 50,000 unit soft gel capsule once per week for 8 weeks.
|
Placebo- Vitamin D
n=45 participants at risk
Placebo soft gel once per week for 8 weeks.
|
Probenecid
n=46 participants at risk
Probenecid 500 mg tablet once per day for 4 weeks, then either 500 mg tablet once per day for 4 weeks or 1000 mg once per day for 4 weeks (8 weeks total).
|
Allopurinol
n=48 participants at risk
Allopurinol 300 mg tablet once per day for 4 weeks then either 300 mg once per day or 600 mg once per day for 4 weeks (8 weeks total).
|
Placebo- Uric Acid
n=51 participants at risk
Placebo tablet once per day for 4 weeks then twice per day for 4 weeks (eight weeks total).
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
9.3%
4/43
All randomized participants who received study intervention.
|
8.9%
4/45
All randomized participants who received study intervention.
|
2.2%
1/46
All randomized participants who received study intervention.
|
12.5%
6/48
All randomized participants who received study intervention.
|
9.8%
5/51
All randomized participants who received study intervention.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/43
All randomized participants who received study intervention.
|
2.2%
1/45
All randomized participants who received study intervention.
|
0.00%
0/46
All randomized participants who received study intervention.
|
0.00%
0/48
All randomized participants who received study intervention.
|
0.00%
0/51
All randomized participants who received study intervention.
|
|
Investigations
Elevated phosphorus
|
0.00%
0/43
All randomized participants who received study intervention.
|
2.2%
1/45
All randomized participants who received study intervention.
|
0.00%
0/46
All randomized participants who received study intervention.
|
0.00%
0/48
All randomized participants who received study intervention.
|
0.00%
0/51
All randomized participants who received study intervention.
|
|
Investigations
Elevated potassium
|
2.3%
1/43
All randomized participants who received study intervention.
|
0.00%
0/45
All randomized participants who received study intervention.
|
0.00%
0/46
All randomized participants who received study intervention.
|
0.00%
0/48
All randomized participants who received study intervention.
|
0.00%
0/51
All randomized participants who received study intervention.
|
|
Nervous system disorders
Headache
|
0.00%
0/43
All randomized participants who received study intervention.
|
0.00%
0/45
All randomized participants who received study intervention.
|
6.5%
3/46
All randomized participants who received study intervention.
|
4.2%
2/48
All randomized participants who received study intervention.
|
3.9%
2/51
All randomized participants who received study intervention.
|
|
General disorders
Fatigue
|
0.00%
0/43
All randomized participants who received study intervention.
|
0.00%
0/45
All randomized participants who received study intervention.
|
8.7%
4/46
All randomized participants who received study intervention.
|
8.3%
4/48
All randomized participants who received study intervention.
|
3.9%
2/51
All randomized participants who received study intervention.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/43
All randomized participants who received study intervention.
|
0.00%
0/45
All randomized participants who received study intervention.
|
2.2%
1/46
All randomized participants who received study intervention.
|
4.2%
2/48
All randomized participants who received study intervention.
|
5.9%
3/51
All randomized participants who received study intervention.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/43
All randomized participants who received study intervention.
|
0.00%
0/45
All randomized participants who received study intervention.
|
4.3%
2/46
All randomized participants who received study intervention.
|
6.2%
3/48
All randomized participants who received study intervention.
|
5.9%
3/51
All randomized participants who received study intervention.
|
|
Vascular disorders
Flushing
|
0.00%
0/43
All randomized participants who received study intervention.
|
0.00%
0/45
All randomized participants who received study intervention.
|
2.2%
1/46
All randomized participants who received study intervention.
|
0.00%
0/48
All randomized participants who received study intervention.
|
2.0%
1/51
All randomized participants who received study intervention.
|
|
General disorders
Tingling in extremities
|
0.00%
0/43
All randomized participants who received study intervention.
|
0.00%
0/45
All randomized participants who received study intervention.
|
0.00%
0/46
All randomized participants who received study intervention.
|
4.2%
2/48
All randomized participants who received study intervention.
|
0.00%
0/51
All randomized participants who received study intervention.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/43
All randomized participants who received study intervention.
|
0.00%
0/45
All randomized participants who received study intervention.
|
2.2%
1/46
All randomized participants who received study intervention.
|
8.3%
4/48
All randomized participants who received study intervention.
|
7.8%
4/51
All randomized participants who received study intervention.
|
|
General disorders
Altered taste
|
0.00%
0/43
All randomized participants who received study intervention.
|
0.00%
0/45
All randomized participants who received study intervention.
|
0.00%
0/46
All randomized participants who received study intervention.
|
6.2%
3/48
All randomized participants who received study intervention.
|
3.9%
2/51
All randomized participants who received study intervention.
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
0.00%
0/43
All randomized participants who received study intervention.
|
0.00%
0/45
All randomized participants who received study intervention.
|
0.00%
0/46
All randomized participants who received study intervention.
|
6.2%
3/48
All randomized participants who received study intervention.
|
3.9%
2/51
All randomized participants who received study intervention.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/43
All randomized participants who received study intervention.
|
0.00%
0/45
All randomized participants who received study intervention.
|
4.3%
2/46
All randomized participants who received study intervention.
|
2.1%
1/48
All randomized participants who received study intervention.
|
0.00%
0/51
All randomized participants who received study intervention.
|
|
Gastrointestinal disorders
Heartburn
|
0.00%
0/43
All randomized participants who received study intervention.
|
0.00%
0/45
All randomized participants who received study intervention.
|
2.2%
1/46
All randomized participants who received study intervention.
|
2.1%
1/48
All randomized participants who received study intervention.
|
0.00%
0/51
All randomized participants who received study intervention.
|
|
General disorders
Transient shortness of breath
|
0.00%
0/43
All randomized participants who received study intervention.
|
0.00%
0/45
All randomized participants who received study intervention.
|
0.00%
0/46
All randomized participants who received study intervention.
|
4.2%
2/48
All randomized participants who received study intervention.
|
0.00%
0/51
All randomized participants who received study intervention.
|
|
General disorders
Transient nose bleed
|
0.00%
0/43
All randomized participants who received study intervention.
|
0.00%
0/45
All randomized participants who received study intervention.
|
0.00%
0/46
All randomized participants who received study intervention.
|
2.1%
1/48
All randomized participants who received study intervention.
|
0.00%
0/51
All randomized participants who received study intervention.
|
|
General disorders
Transient facial swelling
|
0.00%
0/43
All randomized participants who received study intervention.
|
0.00%
0/45
All randomized participants who received study intervention.
|
0.00%
0/46
All randomized participants who received study intervention.
|
0.00%
0/48
All randomized participants who received study intervention.
|
2.0%
1/51
All randomized participants who received study intervention.
|
|
General disorders
Unusual reaction to bee sting
|
0.00%
0/43
All randomized participants who received study intervention.
|
0.00%
0/45
All randomized participants who received study intervention.
|
0.00%
0/46
All randomized participants who received study intervention.
|
0.00%
0/48
All randomized participants who received study intervention.
|
2.0%
1/51
All randomized participants who received study intervention.
|
|
Nervous system disorders
Sleepiness
|
0.00%
0/43
All randomized participants who received study intervention.
|
0.00%
0/45
All randomized participants who received study intervention.
|
0.00%
0/46
All randomized participants who received study intervention.
|
2.1%
1/48
All randomized participants who received study intervention.
|
0.00%
0/51
All randomized participants who received study intervention.
|
|
Nervous system disorders
Difficulty sleeping
|
0.00%
0/43
All randomized participants who received study intervention.
|
0.00%
0/45
All randomized participants who received study intervention.
|
0.00%
0/46
All randomized participants who received study intervention.
|
0.00%
0/48
All randomized participants who received study intervention.
|
2.0%
1/51
All randomized participants who received study intervention.
|
|
Nervous system disorders
Sensitivity to touch
|
0.00%
0/43
All randomized participants who received study intervention.
|
0.00%
0/45
All randomized participants who received study intervention.
|
0.00%
0/46
All randomized participants who received study intervention.
|
2.1%
1/48
All randomized participants who received study intervention.
|
0.00%
0/51
All randomized participants who received study intervention.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place