The Effect of Vitamin D Statues on Endothelial Function (CVD Cookie)
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|ClinicalTrials.gov Identifier: NCT01049048|
Recruitment Status : Completed
First Posted : January 14, 2010
Last Update Posted : October 5, 2015
In the United States, cardiovascular disease causes over one-third of all deaths and vitamin D deficiency is an epidemic. An increasing body of data suggests that low vitamin D status adversely impacts the cardiovascular system. It is our fundamental hypothesis that vitamin D deficiency is a risk factor for cardiovascular disease by causing endothelial dysfunction. Moreover, we hypothesize that vitamin D supplementation will restore endothelial function, thereby reducing cardiovascular disease risk.
This pilot research will be conducted in 64 post-menopausal women participating in an existing study of vitamin D supplementation (32 will receive vitamin D3 2,500 IU daily, the others matching placebo) and will explore the effects of vitamin D on endothelial function and arterial reactivity. Post-menopausal women aged 55-65 years are chosen due to their highest risk for development of a subsequent new cardiovascular disease diagnosis. All study participants will have fasting laboratory and noninvasive vascular ultrasound studies performed at baseline and four months later. The primary outcome measure of this pilot study is change in markers of endothelial function and arterial stiffness with vitamin D3 therapy. If our hypotheses are correct, our long-term goals include investigation of the effect of vitamin D repletion on subclinical atherosclerosis and subsequent cardiovascular events.
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Diseases Vitamin D Deficiency||Dietary Supplement: Vitamin D3 Dietary Supplement: Placebo||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||The Effect of Vitamin D Statues on Endothelial Function|
|Study Start Date :||March 2009|
|Actual Primary Completion Date :||October 2010|
|Actual Study Completion Date :||October 2010|
Placebo Comparator: Control
This group receives placebo chocolate cookies with no vitamin D3 added.
Dietary Supplement: Placebo
No (0 IU) vitamin D3 added to cookie.
Experimental: Vitamin D3
This group receives 2500 IU of Vitamin D3 added to a chocolate cookie daily.
Dietary Supplement: Vitamin D3
2500 IU Vitamin D3
- The primary outcome measure of this pilot study is change in markers of endothelial function and arterial stiffness with vitamin D3 therapy. [ Time Frame: 17 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01049048
|United States, Wisconsin|
|University of Wisconsin Osteoporosis Clinical and Research Program|
|Madison, Wisconsin, United States, 53705|
|Principal Investigator:||Rekha Ramamurthy, M.D.||University of Wisconsin Osteoporosis Clinical Center and Research Program|
|Study Director:||Neil C Binkley, M.D.||University of Wisconsin Osteoporosis Clinical Center and Research Program|