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临床试验/NCT00723385
NCT00723385已完成不适用

Effects of Vitamin D on Lipids

University of California, San Francisco2 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2008年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
130
试验地点
2
主要终点
LDL-cholesterol

研究概览

简要总结

The purpose of this study is to examine whether oral vitamin D supplementation in people with inadequate vitamin D concentrations will lower LDL-cholesterol and total cholesterol concentrations.

详细描述

Data from previous trials suggest a protective role of vitamin D in cardiovascular disease. A recent meta-analysis of trials with at least 5 years of follow-up of vitamin D supplementation concluded that intake of vitamin D supplements may decrease total mortality, but that the relationship between baseline vitamin D status, dose of vitamin D supplements, and total mortality rates remains to be investigated. An even more recent analysis of vitamin D concentrations found that participants with vitamin D deficiency and hypertension were about twice as likely as people without hypertension and vitamin D deficiency to have a cardiovascular event during the study.

The main hypothesis to be tested is that normalization of vitamin D levels will lower LDL-cholesterol and total cholesterol concentrations in people with inadequate vitamin D concentrations as determined by circulating 25-OH vitamin D. Subhypotheses are that HDL-cholesterol, triglycerides, lipoprotein(a), hs C-reactive protein and Hemoglobin A1c will not be affected, and that cyp3a-metabolized medication levels will decrease with vitamin D replacement.

This is a 12-week randomized double-blind dose titration study of the effects of supplementation with 1000-2000 IU vitamin D on lipid and vitamin D concentrations. Dietary intake of vitamin D will be estimated by dietary recall questionnaire or analysis of three non-consecutive 24-hour dietary intake logs.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Any medically stable person able to swallow pills
  • Inadequate vitamin D status at screening visit

排除标准

  • Clinical instability of underlying disease process (e.g., recent hospitalization, change of dosages of medications within the prior two weeks, or new medications within one month)
  • Recent transfusion
  • Severe renal failure or dialysis
  • Hypercalcemia
  • Malignancy under active treatment
  • Feeding tube
  • Intestinal bypass surgery
  • Inability to swallow tablets

结局指标

主要结局

LDL-cholesterol

时间窗: 12 weeks

次要结局

  • Vitamin D and metabolite concentrations with supplementation and time course of repletion in deficient or insufficient subjects(12 weeks)
  • Measures of inflammatory markers(12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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