The Effect of Vitamin D Statues on Endothelial Function
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The primary outcome measure of this pilot study is change in markers of endothelial function and arterial stiffness with vitamin D3 therapy.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 55 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy, community-dwelling ambulatory post-menopausal women.
- •Able and willing to sign informed consent.
- •Ages: 55-
- •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.
排除标准
- •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.
研究组 & 干预措施
Control
This group receives placebo chocolate cookies with no vitamin D3 added.
干预措施: Placebo (Dietary Supplement)
Vitamin D3
This group receives 2500 IU of Vitamin D3 added to a chocolate cookie daily.
干预措施: Vitamin D3 (Dietary Supplement)
结局指标
主要结局
The primary outcome measure of this pilot study is change in markers of endothelial function and arterial stiffness with vitamin D3 therapy.
时间窗: 17 months
次要结局
未报告次要终点