| Trial ID: | L2511 |
| Source ID: | NCT01635062
|
| Associated Drug: |
Calcitriol
|
| Title: |
The VALIDATE-D Study
|
| Acronym: |
VALIDATE-D
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01635062/results
|
| Conditions: |
Type 2 Diabetes|Obesity
|
| Interventions: |
DRUG: Calcitriol|DRUG: Placebo
|
| Outcome Measures: |
Primary: The Change in Circulating RAS Activity After Calcitriol/Placebo Therapy, The below results represent the change in Plasma Renin Activity., baseline and 2 weeks following calcitriol/placebo therapy | Secondary: Change in Renal Plasma Flow After Calcitriol/Placebo Therapy, Subjects 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., baseline and 3 weeks following calcitriol/placebo therapy|Change in Urine Protein After Calcitriol/Placebo Therapy, Subjects have their urine protein assessed at baseline while sodium loaded and again 3 weeks after randomized therapy with calcitriol or placebo., baseline and 3 weeks following calcitriol/placebo therapy
|
| Sponsor/Collaborators: |
Sponsor: Brigham and Women's Hospital
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
41
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: PREVENTION
|
| Start Date: |
2012-09
|
| Completion Date: |
2015-12
|
| Results First Posted: |
2017-04-11
|
| Last Update Posted: |
2017-04-11
|
| Locations: |
Brigham and Women's Hospital, Boston, Massachusetts, 02115, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01635062
|
