A Trial Evaluating Vitamin D Normalization on Major Adverse Cardiovascular-Related Events Among Myocardial Infarction Patients (The TARGET-D Study)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 634
- 试验地点
- 1
- 主要终点
- Composite Outcome of Death, Myocardial Infarction, Heart Failure Hospitalization, and Cerebral Vascular Accident
研究概览
简要总结
This study evaluates whether achieving 25-hydroxyvitamin D (25[OH] Vit D) levels (>40 ng/mL) among myocardial infarction patients will result in a reduction of cardiovascular-related adverse events. Half of the patients will be randomized to receive standard of care and half will receive clinical management of 25[OH] Vit D levels.
详细描述
Low 25[OH] Vit D levels have become a public epidemic with increasing recognition of its widespread insufficiency both in the United States and worldwide. Epidemiologic studies have associated low 25[OH] Vit D levels with coronary risk factors and adverse cardiovascular outcomes. However, randomized trials are needed to establish the relevance of 25[OH] Vit D status to cardiovascular health. While a few randomized trials have evaluated vitamin D supplementation, none have "treated to target" (i.e., individual dosing so that adequate 25[OH] Vit D levels are obtained), but have rather given "blanket" doses regardless of 25[OH] Vit D level.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients, both male and female, >18 years old
- •Undergone angiography for a MI (troponin positive [>0.04 ng/mL] and ACS diagnosis) within the past month
- •Receive follow-up care at an Intermountain Healthcare facility
- •Not taking or taking <1000 IU of vitamin D daily within the last 3 months
- •Willing to provide informed consent and participate in follow-up visits
排除标准
- •Hypersensitivity to vitamin D products
- •History of previous vitamin D supplementation of >1000 IU daily within the past 3 months (i.e., >40% of the days during the past 3 months).
- •Systemic disease (including terminal cancer, cirrhosis, end stage COPD, etc) with a reduced (<12 months) life expectancy
- •Hypercalcemia (calcium levels >10.6 mg/dL)
- •Subject participation in previous investigational interventional studies within 30 days of the current study.
- •History of psychiatric illness/condition that would interfere with their ability to understand or complete the requirements of the study, a condition that in the opinion of the investigator or their designee places the subject at an unacceptable risk as a participant.
- •Pregnant and/or lactating women and women of child bearing potential who are not using acceptable means of contraception as determined by the clinical investigators.
研究组 & 干预措施
Treatment
Patients randomized to the treatment arm will have a 25[OH] Vit D test performed, a sample taken and stored for future tests, and completion of a PHQ-9 depression survey. If at baseline a patient has a 25[OH] Vit D >40 ng/mL then follow-up testing will occur 1 year from baseline and the patient will continue current treatment strategy (no supplementation or current supplementation dosage). If baseline 25[OH] Vit D levels are <40 ng/mL then the patient will initiate or increase dose and return in 3 months (±15 days) to determine 25[OH] Vit D level. At 3 months, if 25[OH] Vit D >40 ng/mL then current dose should be kept and the patient will return in 1 year for follow-up testing. However, if 25[OH] Vit D <40 ng/mL then patients should double current dose and test again in 3 months. This should occur until 25[OH] Vit D reaches a level >40 ng/mL and once achieved, the patient will return in 1 year for follow-up 25[OH] Vit D testing.
干预措施: Vitamin D3 (Biological)
结局指标
主要结局
Composite Outcome of Death, Myocardial Infarction, Heart Failure Hospitalization, and Cerebral Vascular Accident
时间窗: from date of randomization until the date of first documented event, up to 48 months
次要结局
未报告次要终点