We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

The VALIDATE-D Study (VALIDATE-D)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01635062
First Posted: July 6, 2012
Last Update Posted: April 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Anand Vaidya, Brigham and Women's Hospital
Results First Submitted: January 6, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Conditions: Type 2 Diabetes
Obesity
Interventions: Drug: Calcitriol
Drug: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

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 Subsequently, 13 were found ineligible, 5 withdrew participation, 3 were lost-to follow-up, and 2 were withdrawn for non-compliance with the washout.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.


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

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blockers, and mineralocorticoid receptor antagonists, beta blockers, diuretics, and calcium-channel blockers were withdrawn for 2 weeks to 2 months prior to randomization.


Reporting Groups
  Description
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.


Participant Flow:   Overall Study
    Calcitriol   Placebo
STARTED   9   9 
Sodium Restriction Baseline Visit [1]   9   9 
Sodium Loading Baseline Visit [2]   9   9 
Post-randomization Sodium Restriction [3]   9   9 
Post-Randomization Sodium Loaded [4]   9   9 
COMPLETED   9   9 
NOT COMPLETED   0   0 
[1] The first study visit was a pre-randomization assessment while sodium restricted (Baseline)
[2] The second study visit was a pre-randomization assessment while sodium loaded (Baseline)
[3] This visit was an assessment while sodium restricted and following 3 weeks of study medication
[4] This visit was an assessment while sodium loaded and following 3 weeks of study medication



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

Total Total of all reporting groups

Baseline Measures
   Calcitriol   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 9   9   18 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      8  88.9%      9 100.0%      17  94.4% 
>=65 years      1  11.1%      0   0.0%      1   5.6% 
Age 
[Units: Years]
Mean (Standard Deviation)
 51.0  (10.4)   50.7  (5.0)   50.8  (7.9) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      2  22.2%      5  55.6%      7  38.9% 
Male      7  77.8%      4  44.4%      11  61.1% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   9   9   18 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   The Change in Circulating RAS Activity After Calcitriol/Placebo Therapy   [ Time Frame: baseline and 2 weeks following calcitriol/placebo therapy ]

2.  Secondary:   Change in Renal Plasma Flow After Calcitriol/Placebo Therapy   [ Time Frame: baseline and 3 weeks following calcitriol/placebo therapy ]

3.  Secondary:   Change in Urine Protein After Calcitriol/Placebo Therapy   [ Time Frame: baseline and 3 weeks following calcitriol/placebo therapy ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
This was a small physiological study, not a treatment study or a typical Phase 1-4 study. The objective was to investigate the mechanistic link between vitamin D receptor agonist therapy and the renin-angiotensin system.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Anand Vaidya (Asst Professor of Medicine)
Organization: Brigham and Women's Hospital
phone: 6175258285 ext 617
e-mail: avaidya1@partners.org


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Anand Vaidya, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01635062     History of Changes
Other Study ID Numbers: 2012P000905
First Submitted: July 2, 2012
First Posted: July 6, 2012
Results First Submitted: January 6, 2017
Results First Posted: April 11, 2017
Last Update Posted: April 11, 2017