Study of Vitamin D Deficiency on Cardiovascular Disease and the Effect of Vitamin D Supplementation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The efficacy on metabolic syndrome
研究概览
简要总结
This is a 9 months, randomized, single center, open-label, parallel-group study to compare the efficacy and safety parameters of vitamin D supplementation in vitamin D deficiency subjects in China.
详细描述
This is a 9 months, randomized, single center, open-label, parallel-group study to compare the efficacy and safety parameters of vitamin D supplementation in vitamin D deficiency subjects in China.
Eligibility for participation will be determined by medical history, physical examination, and laboratory results obtained during a screening visit. About 300 subjects with vitamin D insufficiency or deficiency will be included in this study. All subjects will be given informed consent before starting any examination and test. The following data of all subject will be collected: liver and kidney function, HbA1c, fasting blood glucose, fasting lipid profile, serum calcium, serum phosphate, parathyroid hormone, 25-hydroxy vitamin D(25OHD), serum procollagen type I N propeptide, serum C-terminal telopeptide of type I collagen, s-CTX and muscle power and balance.
After baseline data are collected, eligible subjects will be randomized into each group at a 1:1 ratio (150 for control group and 150 for vitamin D supplementation group, less than 20% drop-off rate is acceptable for this study). The initial vitamin D doses will be based on 25OHD levels at basis, and this dosage may be changed according be the level of 25OHD until the end of this study.
All subjects in the control group will be followed every half year. All subjects in the vitamin D group will be followed by visiting clinic, and will be titrated their doses. Dose adjustment should be aimed at achieving the following 25OHD targets: 30ng/ml. If above 25OHD target has not been achieved, vitamin D dose should be adjusted. Clinic visit will be conducted 3 months later to collect information, such as serum calcium, 25OHD and adverse events.
Complicated examinations will be repeated again after 9 months treatments for both groups, including physical examination, liver and kidney function, HbA1c, fasting blood glucose, fasting lipid profile, serum calcium, serum phosphate, parathyroid hormone, 25-hydroxy vitamin D(25OHD), serum procollagen type I N propeptide, serum C-terminal telopeptide of type I collagen, s-CTX and muscle power and balance. Data will be collected and analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent obtained before any trial-related activities. (Trial- related activities are any procedure that would not have been performed during normal management of the subject.)
- •25OHD<30ng/ml
排除标准
- •Severe systemic disease (including severe heart, liver, kidney and lung diseases, severe infection, mental disorder and connective tissue disease)
- •Primary hyperparathyroidism, other bone disease, malabsorption and other chronic gastrointestinal disease.
- •Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures.
- •Use of systemic or inhaled glucocorticoids or other medication known to interfere with bone metabolism.
- •Use of vitamin D related agents in recent 3 months.
研究组 & 干预措施
control
A total of 150 subjects were recruited in the control group.
干预措施: control (Other)
vitamin D,capsule
A total of 150 subjects were recruited in the vitamin D supplementation group.
干预措施: vitamin D (Other)
结局指标
主要结局
The efficacy on metabolic syndrome
时间窗: 9 months
The change of metabolic syndrome after vitamin D supplementation
The efficacy on serum 25(OH)VitD level
时间窗: 9 months
The change of serum 25(OH)VitD level after vitamin D supplementation
次要结局
- The efficacy on blood lipid(9 months)
- The efficacy on bone biomarkers(9 months)
- The efficacy on blood glucose(9 months)
- The efficacy on blood pressure(9 months)
研究者
Chunlin Li
Professor
Chinese PLA General Hospital