The Effect of Vitamin D Statues on Endothelial Function
| Status: | Completed |
|---|---|
| Conditions: | Other Indications, Peripheral Vascular Disease, Gastrointestinal |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Gastroenterology, Other |
| Healthy: | No |
| Age Range: | 55 - 65 |
| Updated: | 4/21/2016 |
| Start Date: | March 2009 |
| End Date: | October 2010 |
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.
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.
Inclusion Criteria:
- Healthy, community-dwelling ambulatory post-menopausal women.
- Able and willing to sign informed consent.
- Ages: 55-65.
- Baseline serum 25OHD concentration > 10 ng/ml and < 60 ng/ml
- Not pregnant
- Willing to avoid use of cod-liver oil and non-study vitamin D supplementation;
standard multiple vitamins containing ≤ 400 IU used no more than once daily will be
allowed.
- Willing to utilize sunscreen of SPF-15 or higher when sun exposure for more than 15
minutes is expected.
- Willing to fast for 12 hours.
Exclusion Criteria:
- Current hypercalcemia (serum calcium > 10.5 mg/dl) or untreated primary
hyperparathyroidism.
- History of nephrolithiasis
- Baseline 24-hour urine calcium > 250 mg
- Known risk factors for hypercalcemia, e.g., malignancy, tuberculosis, sarcoidosis,
Paget's disease.
- History of any form of cancer within the past five years with the exception of
adequately treated squamous cell or basal cell skin carcinoma.
- Known previous personal history of cardiovascular disease.
- Renal failure; defined as a calculated creatinine clearance (using the Cockroft-Gault
approach) of ≤ 25 ml/minute.
- Severe end-organ disease, e.g., cardiovascular, hepatic, hematologic, pulmonary,
etc., which might limit the ability to complete this study.
- Treatment with any drug known to interfere with vitamin D metabolism, e.g.,
phenytoin, phenobarbital.
- Known malabsorption syndromes, e.g., celiac disease, active inflammatory bowel
disease, etc.
- Known allergy to chocolate.
- Use of medications known to alter bone turnover including bisphosphonates, estrogen,
selective estrogen receptor modulators, parathyroid hormone, testosterone or
calcitonin.
- Treatment with any active metabolites of vitamin D, e.g., calcitriol, within six
months of screening.
- Use of tanning beds or salons or unwillingness to utilize sunscreen during periods of
sun exposure of 15 minutes or longer.
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