Trial Outcomes & Findings for The VALIDATE-D Study (NCT NCT01635062)
NCT ID: NCT01635062
Last Updated: 2017-04-11
Results Overview
The below results represent the change in Plasma Renin Activity.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
41 participants
Primary outcome timeframe
baseline and 2 weeks following calcitriol/placebo therapy
Results posted on
2017-04-11
Participant Flow
Subjects were recruited from the local Boston community A total of 41 participants were consented to participate. Subsequently, 13 were found ineligible, 5 withdrew participation, 3 were lost-to follow-up, and 2 were withdrawn for non-compliance with the washout. Therefore, 18 were randomized.
An anti-hypertensive medication washout was conducted to minimize confounding of the renin-angiotensin system. ACE inhibitors, angiotensin-receptor blockers, and mineralocorticoid receptor antagonists, beta blockers, diuretics, and calcium-channel blockers were withdrawn for 2 weeks to 2 months prior to randomization.
Participant milestones
| Measure |
Calcitriol
Subjects will receive calcitriol (titrated up to 0.75 mcg daily) for 3 weeks.
Subjects have their renin-angiotensin system, renal plasma flow, and urine protein assessed at baseline while sodium restricted and sodium loaded. They will then be randomized to receive calcitriol (up to 0.75 mcg daily) or placebo for 3 weeks, and repeat assessments again while sodium restricted and sodium loaded.
|
Placebo
Subjects will receive placebo for 3 weeks.
Subjects have their renin-angiotensin system, renal plasma flow, and urine protein assessed at baseline while sodium restricted and sodium loaded. They will then be randomized to receive calcitriol (up to 0.75 mcg daily) or placebo for 3 weeks, and repeat assessments again while sodium restricted and sodium loaded.
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
9
|
|
Overall Study
Sodium Restriction Baseline Visit
|
9
|
9
|
|
Overall Study
Sodium Loading Baseline Visit
|
9
|
9
|
|
Overall Study
Post-randomization Sodium Restriction
|
9
|
9
|
|
Overall Study
Post-Randomization Sodium Loaded
|
9
|
9
|
|
Overall Study
COMPLETED
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The VALIDATE-D Study
Baseline characteristics by cohort
| Measure |
Calcitriol
n=9 Participants
Subjects will receive calcitriol (titrated up to 0.75 mcg daily) for 3 weeks.
Subjects have their renin-angiotensin system, renal plasma flow, and urine protein assessed at baseline while sodium restricted and sodium loaded. They will then be randomized to receive calcitriol (up to 0.75 mcg daily) or placebo for 3 weeks, and repeat assessments again while sodium restricted and sodium loaded.
|
Placebo
n=9 Participants
Subjects will receive placebo for 3 weeks.
Subjects have their renin-angiotensin system, renal plasma flow, and urine protein assessed at baseline while sodium restricted and sodium loaded. They will then be randomized to receive calcitriol (up to 0.75 mcg daily) or placebo for 3 weeks, and repeat assessments again while sodium restricted and sodium loaded.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Age, Continuous
|
51.0 years
STANDARD_DEVIATION 10.4 • n=99 Participants
|
50.7 years
STANDARD_DEVIATION 5.0 • n=107 Participants
|
50.8 years
STANDARD_DEVIATION 7.9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
9 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: baseline and 2 weeks following calcitriol/placebo therapyThe below results represent the change in Plasma Renin Activity.
Outcome measures
| Measure |
Calcitriol
n=9 Participants
Subjects have their plasma renin activity assessed at baseline while sodium restricted, and again after 2 weeks of randomized therapy with calcitriol (up to 0.75 mcg daily) or placebo.
|
Placebo
n=9 Participants
Subjects have their plasma renin activity assessed at baseline while sodium restricted, and again after 2 weeks of randomized therapy with calcitriol (up to 0.75 mcg daily) or placebo.
|
|---|---|---|
|
The Change in Circulating RAS Activity After Calcitriol/Placebo Therapy
|
0 ng/mL/h
Interval -1.3 to 0.3
|
-1.3 ng/mL/h
Interval -3.6 to -0.3
|
SECONDARY outcome
Timeframe: baseline and 3 weeks following calcitriol/placebo therapySubjects had their renal plasma flow assessed at baseline while sodium loaded, and again after 3 weeks of randomized therapy with either calcitriol (up to 0.75 mcg daily) or placebo.
Outcome measures
| Measure |
Calcitriol
n=9 Participants
Subjects have their plasma renin activity assessed at baseline while sodium restricted, and again after 2 weeks of randomized therapy with calcitriol (up to 0.75 mcg daily) or placebo.
|
Placebo
n=9 Participants
Subjects have their plasma renin activity assessed at baseline while sodium restricted, and again after 2 weeks of randomized therapy with calcitriol (up to 0.75 mcg daily) or placebo.
|
|---|---|---|
|
Change in Renal Plasma Flow After Calcitriol/Placebo Therapy
|
-16.4 mL/min/1.73m2
Standard Deviation 180.5
|
-0.6 mL/min/1.73m2
Standard Deviation 142.2
|
SECONDARY outcome
Timeframe: baseline and 3 weeks following calcitriol/placebo therapySubjects have their urine protein assessed at baseline while sodium loaded and again 3 weeks after randomized therapy with calcitriol or placebo.
Outcome measures
| Measure |
Calcitriol
n=9 Participants
Subjects have their plasma renin activity assessed at baseline while sodium restricted, and again after 2 weeks of randomized therapy with calcitriol (up to 0.75 mcg daily) or placebo.
|
Placebo
n=9 Participants
Subjects have their plasma renin activity assessed at baseline while sodium restricted, and again after 2 weeks of randomized therapy with calcitriol (up to 0.75 mcg daily) or placebo.
|
|---|---|---|
|
Change in Urine Protein After Calcitriol/Placebo Therapy
|
21.1 mg/24h
Standard Deviation 95.7
|
8.1 mg/24h
Standard Deviation 51.0
|
Adverse Events
Calcitriol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Anand Vaidya (Asst Professor of Medicine)
Brigham and Women's Hospital
Phone: 6175258285
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place