Effects of High and Low Dose Vitamin D Suppletion on Postprandial Leukocyte Activation, Oxidative Stress and Vascular Function in Healthy Overweight and Obese Females
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- effect of vitamin D on leukocyte cluster of differentiation antigen 11b expression
研究概览
简要总结
Administration of vitamin D will have a beneficial effect on postprandial leukocyte activation, oxidative stress and arterial stiffness in vitamin D deficient females. High doses of vitamin D may have a more pronounced effect than low doses.
详细描述
Rationale: Postprandial lipemia, known to be associated with acute leukocyte activation, impairs endothelial function and promotes atherosclerosis. Deficiency of vitamin D is associated with increased cardiovascular risk, but the precise mechanism is still unclear. A recent pilot study performed in our laboratory showed improved postprandial vascular function by pulse wave analysis and decreased postprandial leukocyte activation after vitamin D supplementation. Interestingly, the effects on leukocyte activation were solely found in females.
Hypothesis: The beneficial effects of vitamin D administration on postprandial leukocyte activation are mediated by suppression of oxidative stress. High doses of vitamin D may have a more pronounced effect than low doses.
Objective: To estimate the effect sizes of different doses of vitamin D on postprandial leukocyte activation markers, oxidative stress and arterial stiffness in vitamin D deficient females.
Study design: Randomized, double blind pilot study. Study population: Premenopausal overweight and obese female volunteers with proven vitamin D deficiency, ≥ 18 years of age.
Intervention: Two oral fat load tests (OFLTs) will be performed. After the first OFLT, volunteers will be randomly assigned to receive a single low dose (75 000 IU) or high dose (300 000 IU) of cholecalciferol drink. One week later the OFLT will be repeated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- Female
- 接受健康志愿者
- 是
入选标准
- •Age of 18 years or older;
- •Pre-menopausal;
- •BMI ≥25.0 kg/m2;
- •Vitamin D deficiency, defined by a 25-hydroxyvitamin D level of <30ng/ml;
- •Use of oral contraceptives.
排除标准
- •The use of any kind of medication except oral contraceptives;
- •Pregnancy;
- •Participation in a clinical study less than 6 months before inclusion;
- •The use of (multi)vitamin supplements.
研究组 & 干预措施
High dose vitamin D
Volunteers assigned to this arm will receive a single dose of oral cholecalciferol 300 000 IU, in the form of 3 ml D-cura drink 100 000 IU/ml
干预措施: Cholecalciferol (Drug)
Low dose vitamin D
Volunteers assigned to this arm will receive a single dose of oral cholecalciferol 75000 IU, in the form of 3 ml D-cura drink 25 000 IU/ml
干预措施: Cholecalciferol (Drug)
结局指标
主要结局
effect of vitamin D on leukocyte cluster of differentiation antigen 11b expression
时间窗: 2, 4, 6 and 8 hours postprandial
the differential effect of 75 000 IU low dose vs. 300 000 IU high dose vitamin D on postprandial leukocyte activation markers cluster of differentiation antigen 11b
次要结局
- Effect of vitamin D on oxidative stress(2,4,6 and 8 hours postprandial)
- Effect of vitamin D on vascular function(0,2,6,8 and 8 hours postprandial)
研究者
M.A. de Vries
MD
Sint Franciscus Gasthuis