Daylight: The Effect of Vitamin D Supplementation on Blood Pressure in Vitamin D Deficient Individuals With Pre-Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 534
- 试验地点
- 3
- 主要终点
- The primary endpoint is defined as the change in mean 24-hour ambulatory systolic blood pressure.
研究概览
简要总结
This is a randomized, double-blind, multicenter, 6-month follow-up trial of low (400 IU/day) versus high (4000 IU/day) dose vitamin D supplementation in individuals with pre- and early stage 1 hypertension and vitamin D deficiency. A total of 530 participants (265 participants per treatment arm) will be randomized between 3 sites. Approximately 2,250 participants will be screened between the 3 sites. Vital signs, 24-hour ambulatory blood pressure monitoring, clinical laboratory safety tests and adverse event assessments will be performed to evaluate the effectiveness of the two doses of vitamin D on blood pressure. Blood samples will be stored for future biomarker assessments. The total duration of the study is anticipated to be 18 months, assuming a 12 month enrollment period.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or females 18 to 50 years of age
- •Systolic blood pressure of 120 to 159 mmHg and Diastolic blood pressure ≤99 mmHg
- •Vitamin D deficiency, defined as 25-hydroxyvitamin D <25 ng/ml
- •No use of any anti-hypertensive medication in last 3 months or anticipated or planned use in next 6 months
- •No use of vitamin D supplementation in last 3 months, defined as vitamin D found in a multivitamin or supplement totaling >400 IU per day or anticipated or planned use in next 6 months
排除标准
- •Use of any anti-hypertensive medication in last 3 months or anticipated or planned use in next 6 months
- •Use of vitamin D supplementation in last 3 months, defined as vitamin D found in a multivitamin or supplement totaling >400 IU per day or anticipated or planned use in next 6 months
- •Use of St. John's wart, rifampin, any treatment for HIV, orlistat, oral glucocorticoids, phenobarbital, phenytoin, mineral oil, or bile acid sequestrants in the last 3 months or anticipated or planned use in next 6 months
- •Female who is pregnant, nursing, or of childbearing potential and planning or anticipating pregnancy in next 6 months
- •History of diabetes mellitus (including Type 1, Type 2 and diet controlled)
- •Serum creatinine >2.0 mg/dl or estimated Glomerular Filtration Rate (GFR) <30 ml/min
- •Calcium >10.0 mg/dl or phosphorus >5 mg/dl
- •History of kidney stones
- •Body mass index >38 kg/m2
- •Known cardiovascular disease: defined as prior myocardial infarction, percutaneous transluminal coronary angioplasty, coronary artery bypass or stroke
- •History of cirrhosis or severe liver disease (defined as history of GI bleeding from liver disease, jaundice or ascites)
- •Current heavy alcohol use: defined as drinking 5 or more drinks per occasion on 5 or more days in the past 30 days
- •History of ulcerative colitis, Crohn's disease, celiac disease, colostomy, pancreatic enzyme deficiency, short bowel syndrome, gastric bypass, cystic fibrosis, or dumping syndrome.
- •Allergy to coconut
- •Regular use or planned use of artificial tanning lights in next 6 months
- •Use of any investigational product or device in last 3 months or planned use in next 6 months
- •Any condition which could limit the ability to complete and comply with 6-month follow up
- •Unwillingness or inability to comply with study requirements
- •Inability to provide informed consent
研究组 & 干预措施
High Dose Arm
4000 IU/day Vitamin D3 (cholecalciferol) supplementation
干预措施: Cholecalciferol (Drug)
Low Dose Arm
400 IU/day Vitamin D3 (cholecalciferol) supplementation
干预措施: Cholecalciferol (Drug)
结局指标
主要结局
The primary endpoint is defined as the change in mean 24-hour ambulatory systolic blood pressure.
时间窗: 24 hours
次要结局
- Change in mean 24-hour ambulatory diastolic blood pressure(24 hours)
- Change in mean daytime and nighttime ambulatory systolic and diastolic blood pressure(24 hours)
- Change in mean clinic systolic and diastolic blood pressure(6 months)
- Change in mean clinic pulse pressure(6 months)
- Relation of vitamin D status to changes in clinic and 24-hour ambulatory blood pressure measurements(6 months)
研究者
Thomas J. Wang, MD
Principal Investigator
Massachusetts General Hospital