Niacin and Endothelial Function in Early CKD

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. Identifier: NCT00852969
Recruitment Status : Completed
First Posted : February 27, 2009
Results First Posted : May 6, 2014
Last Update Posted : May 6, 2014
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Tufts Medical Center

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Chronic Kidney Disease
Interventions: Drug: Niacin
Drug: Active Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
All patients were recruited at Tufts Medical Center. Dates of recruitment were 9/2008 to 11/2011

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There was no washout period. Patients receiving Niacin were excluded from the study.

Reporting Groups
Niacin Niacin : 1000 mg tablets once per day
Placebo Active Placebo : 100 mg Niacin tablets once per day. Placebo tablets had same appearance

Participant Flow:   Overall Study
    Niacin   Placebo
STARTED   15   15 
COMPLETED   15   13 
Adverse Event                0                1 
Lost to Follow-up                0                1 

  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.
These were the number of individuals who agreed to be randomized for the study

Reporting Groups
Niacin Niacin : 1000 mg tablets once per day
Placebo Active Placebo : 100 mg Niacin tablets once per day. Placebo tablets had same appearance
Total Total of all reporting groups

Baseline Measures
   Niacin   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 15   15   30 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   10   13   23 
>=65 years   5   2   7 
[Units: Years]
Mean (Standard Deviation)
 58.1  (10.9)   50.4  (11.9)   54.2  (11.9) 
[Units: Participants]
Female   6   11   17 
Male   9   4   13 
Region of Enrollment 
[Units: Participants]
United States   15   15   30 

  Outcome Measures

1.  Primary:   Change in the Flow Mediated Dilation From Baseline   [ Time Frame: 14 weeks since baseline ]

2.  Secondary:   Change in HDL-C From Baseline to 14 Weeks   [ Time Frame: 14 weeks since baseline ]

  Serious Adverse Events

  Other Adverse Events

  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
No text entered.

  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: Mark Sarnak, MD
Organization: Tufts Medical Center
phone: 617 636-1182

Responsible Party: Tufts Medical Center Identifier: NCT00852969     History of Changes
Other Study ID Numbers: 5R21DK077368 ( U.S. NIH Grant/Contract )
5R21DK077368-02 ( U.S. NIH Grant/Contract )
First Submitted: February 26, 2009
First Posted: February 27, 2009
Results First Submitted: November 27, 2013
Results First Posted: May 6, 2014
Last Update Posted: May 6, 2014