Effect of Vitamin D3 on Vascular Function
| Status: | Archived |
|---|---|
| Conditions: | Other Indications, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | July 2009 |
| End Date: | December 2010 |
The Effect of Cholecalciferol (Vitamin D3) on Vascular Function and Cardiovascular Risk Factors
Vitamin D is a natural nutrient. A little comes from our normal daily diet. Most of it comes
from our skin after we have been in sunlight. If we have darker skin, we make less vitamin
D. Vitamin D balances the calcium in our body. If our vitamin D levels get too low it can
cause health problems. It may increase our chance of getting high blood pressure or
diabetes. Another problem we may have if our vitamin D levels are low is that our blood
vessels may not work normally. These are important health problems for anyone. Because
African Americans have darker skin, they are more likely than most other racial/ethnic
groups to have low vitamin D levels. This study will look at treating African Americans with
low vitamin D levels.
The goal of this study is to see how vitamin D helps blood vessels work. The investigators
will do this study in African Americans who are overweight, have high blood pressure and
have low vitamin D levels. The investigators will see if getting the vitamin D level to a
normal value will improve how blood vessels work. The dose of vitamin D that will be given
in this study is a high dose that is given to people with low vitamin D levels.
Cardiovascular Disease (CVD) and related disorders remain the leading cause of death in the
nation. Hypovitaminosis D has been linked not only to several cardiovascular (CV) risk
factors including hypertension, diabetes, obesity but also to increased rates of CVD.
Thus,hypovitaminosis D presents a common pathway for a select subgroup with a clustering of
CV risk factors in a profile that is predominant among ethnic minorities. Indeed,
hypovitaminosis D is highly prevalent with an estimated 55% of the US adult population
having levels at or below 30 ng/ml, and over 80% of African Americans having suboptimal
values. Thus, we propose a twelve week randomized double-blind, placebo controlled pilot
trial to assess the effect on vascular function and CV risk factors of 100,000 IU Vitamin D3
given every 4 weeks to overweight, hypertensive African-Americans with hypovitaminosis D.
To our knowledge, the proposed project is the first to assess the effect of 'high-dose'
Vitamin D3 administration on vascular function.We believe this study is also the first to
examine the impact at a molecular level of Vitamin D3 repletion on the key mediators of
cardio-metabolic pathways in humans. If our study results support our working hypothesis, we
will be positioned to propose a larger scale study to detect a therapeutic effect on more
definitive, clinical cardiovascular endpoints across a more diverse population.
We found this trial at
1
site
1731 E 120th Street
Los Angeles, California 90059
Los Angeles, California 90059
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