Trial · NCT01320722

Study of Vitamin D and Uric Acid Lowering on Kidney and Blood Vessel Function

NCT01320722, Phase 3, Completed, Brigham and Women's Hospital; results first posted 2017-06-29

3 sourcestrials-2026-11-12-0.4.0

Cite this record

ConductScience Library. Study of Vitamin D and Uric Acid Lowering on Kidney and Blood Vessel Function. Trials, record NCT01320722. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01320722

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study of Vitamin D and Uric Acid Lowering on Kidney and Blood Vessel Function
NCT number: NCT01320722
Status: Completed
Phases: Phase 3
Enrollment: 242 participants, actual
Lead sponsor: Brigham and Women's Hospital
Conditions: Renal Function, Endothelial Function, Blood Pressure, Overweight, Obesity
Interventions: Vitamin D ergocalciferol, Probenecid, Allopurinol, Placebo, Placebo
First posted: 2011-03-22
Last updated: 2017-06-29
Results first posted: 2017-06-29

Source ClinicalTrials.gov

Registered outcomes9

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Renal Plasma Flow (RPF) in Response to Captopril in High Sodium Balance [Vitamin D]	Week 8 (pre and post captopril)	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.
Primary	Plasma Renin Activity (PRA) [Vitamin D]	Week 8	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.
Primary	Angiotensin II (ATII) Concentration [Vitamin D]	Week 8	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.
Primary	Change in Renal Plasma Flow (RPF) Response to Captopril in High Sodium Balance [Uric Acid]	Week 8 (pre and post captopril)	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.
Primary	Plasma Renin Activity (PRA) [Uric Acid]	Week 8	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.
Primary	Angiotensin II (ATII) Concentration [Uric Acid]	Week 8	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.
Secondary	Change in Endothelium-Dependent Vasodilation (EDV)	Baseline and Week 8 (pre and post ischaemic stimulus)	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.
Secondary	Mean 24-Hour Ambulatory Blood Pressure (ABP)	Baseline and Week 8	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.
Secondary	Mean 24-Hour Ambulatory Blood Pressure (ABP) Nocturnal Dipping	Baseline and Week 8	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.

Source ClinicalTrials.gov

Outcomes9

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Renal Plasma Flow (RPF) in Response to Captopril in High Sodium Balance [Vitamin D]	Week 8 (pre and post captopril)	All randomized enrolled participants included in the analysis.	mL/min per 1.73 m^2	MEAN
PRIMARY	Plasma Renin Activity (PRA) [Vitamin D]	Week 8	All randomized enrolled participants included in the analysis.	ng/mL per hour	MEAN
PRIMARY	Angiotensin II (ATII) Concentration [Vitamin D]	Week 8	All randomized enrolled participants included in the analysis.	pg/mL	MEAN
PRIMARY	Change in Renal Plasma Flow (RPF) Response to Captopril in High Sodium Balance [Uric Acid]	Week 8 (pre and post captopril)	All randomized enrolled participants with data available for analysis.	mL/min per 1.73 m^2	MEDIAN
PRIMARY	Plasma Renin Activity (PRA) [Uric Acid]	Week 8	All randomized enrolled participants with data available for analysis.	ng/mL per hour	MEDIAN
PRIMARY	Angiotensin II (ATII) Concentration [Uric Acid]	Week 8	All randomized enrolled participants with data available for analysis.	pg/mL	MEDIAN
SECONDARY	Change in Endothelium-Dependent Vasodilation (EDV)	Baseline and Week 8 (pre and post ischaemic stimulus)	All randomized enrolled participants.	percent of brachial luminal diameter	MEAN
SECONDARY	Mean 24-Hour Ambulatory Blood Pressure (ABP)	Baseline and Week 8	All randomized enrolled participants with complete 24-hour ABP data available for analysis.	mmHg	MEAN
SECONDARY	Mean 24-Hour Ambulatory Blood Pressure (ABP) Nocturnal Dipping	Baseline and Week 8	All randomized enrolled participants with complete 24-hour ABP data available for analysis.	percent change	MEAN

Source ClinicalTrials.gov

Results by group75

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change in Renal Plasma Flow (RPF) in Response to Captopril in High Sodium Balance [Vitamin D]	Vitamin D	35.7	Standard Deviation 47.7	mL/min per 1.73 m^2
Change in Renal Plasma Flow (RPF) in Response to Captopril in High Sodium Balance [Vitamin D]	Placebo- Vitamin D	35.9	Standard Deviation 26.2	mL/min per 1.73 m^2
Plasma Renin Activity (PRA) [Vitamin D]	Vitamin D	0.36	Standard Deviation 0.44	ng/mL per hour
Plasma Renin Activity (PRA) [Vitamin D]	Placebo- Vitamin D	0.44	Standard Deviation 0.8	ng/mL per hour
Angiotensin II (ATII) Concentration [Vitamin D]	Vitamin D	19.5	Standard Deviation 4.4	pg/mL
Angiotensin II (ATII) Concentration [Vitamin D]	Placebo- Vitamin D	19.7	Standard Deviation 7.1	pg/mL
Change in Renal Plasma Flow (RPF) Response to Captopril in High Sodium Balance [Uric Acid]	Probenecid	33	Inter-Quartile Range 12 to 72	mL/min per 1.73 m^2
Change in Renal Plasma Flow (RPF) Response to Captopril in High Sodium Balance [Uric Acid]	Allopurinol	36	Inter-Quartile Range 17 to 55	mL/min per 1.73 m^2
Change in Renal Plasma Flow (RPF) Response to Captopril in High Sodium Balance [Uric Acid]	Placebo- Uric Acid	30	Inter-Quartile Range -1 to 48	mL/min per 1.73 m^2
Plasma Renin Activity (PRA) [Uric Acid]	Probenecid	0.4	Inter-Quartile Range 0.2 to 0.7	ng/mL per hour

1 to 10 of 75Source ClinicalTrials.gov

See all 75 results by group

Participant flow20

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Vitamin D	46
Overall Study	STARTED	Placebo- Vitamin D	47
Overall Study	STARTED	Probenecid	47
Overall Study	STARTED	Allopurinol	49
Overall Study	STARTED	Placebo- Uric Acid	53
Overall Study	Received Intervention	Vitamin D	43
Overall Study	Received Intervention	Placebo- Vitamin D	45
Overall Study	Received Intervention	Probenecid	46
Overall Study	Received Intervention	Allopurinol	48
Overall Study	Received Intervention	Placebo- Uric Acid	51

1 to 10 of 20Source ClinicalTrials.gov

See all 20 participant flow

Adverse events130

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Abdominal discomfort	Gastrointestinal disorders	Vitamin D	4	43
other	Abdominal discomfort	Gastrointestinal disorders	Placebo- Vitamin D	4	45
other	Abdominal discomfort	Gastrointestinal disorders	Probenecid	1	46
other	Abdominal discomfort	Gastrointestinal disorders	Allopurinol	6	48
other	Abdominal discomfort	Gastrointestinal disorders	Placebo- Uric Acid	5	51
other	Dry mouth	Gastrointestinal disorders	Vitamin D	0	43
other	Dry mouth	Gastrointestinal disorders	Placebo- Vitamin D	1	45
other	Dry mouth	Gastrointestinal disorders	Probenecid	0	46
other	Dry mouth	Gastrointestinal disorders	Allopurinol	0	48
other	Dry mouth	Gastrointestinal disorders	Placebo- Uric Acid	0	51

1 to 10 of 130Source ClinicalTrials.gov

See all 130 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Vitamin D
Total, all-cause mortality	Placebo- Vitamin D
Total, all-cause mortality	Probenecid
Total, all-cause mortality	Allopurinol
Total, all-cause mortality	Placebo- Uric Acid
Total, other adverse events	Vitamin D	5	43
Total, other adverse events	Placebo- Vitamin D	6	45
Total, other adverse events	Probenecid	16	46
Total, other adverse events	Allopurinol	36	48
Total, other adverse events	Placebo- Uric Acid	25	51

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R01HL105440	MODifiable Effectors of Renin System Activation: Treatment Evaluation	FORMAN, JOHN P	BRIGHAM AND WOMEN'S HOSPITAL	NATIONAL HEART, LUNG, AND BLOOD INSTITUTE	2011 to 2015

Source NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Source

Release: trials-2026-11-12-0.4.0
Release manifest SHA-256: 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
Registry capture: 2026-11-12
Results copy, AACT: 2026-03-23
NIH clinical studies file: 2026-11-13

Source ClinicalTrials.gov

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNone stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01320722

GET https://conductscience.org/api/trials/v1/NCT01320722/results?page=2

API reference For AI assistants