EUCTR2013-003514-40-NO进行中（未招募）不适用
The effect of vitamin D supplementation on cardiovascular risk factors in subjects with low serum 25-hydroxyvitamin D levels
niversity Hospital of North Norway0 个研究点开始时间: 2013年8月20日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •males and females 20 - 80 yearts
- •participated in the 7th Tromsø study
- •low serum 25OHD (< 35 nmol/L)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 500
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 500
排除标准
- •-subjects allergic to nuts (the study capsules contain peanut oil)
- •-subjects with primary hyperparathyroidism
- •-granulomatous diseases (sarcoidosis, tuberculosis, Wegner’s granulomatosis)
- •-reduced kidney function (creatinine > 130 µmol/L in males and 120 µmol/L in females)
- •-systolic BP > 174 mmHg, diastolic BP > 104 mmHg,
- •-diabetes (fasting blood glucose > 6.9 mmol/L and/or HbA1c > 6.5 %)
- •-renal stones the last 5 years
- •-subjects who use solarium on a regular basis (more than twice a month on average)
- •-subjects who plan holiday(s) in tropical areas (or Mediterranean during the summer months) for more than two weeks
- •-subjects with BDI score higher than 29
- •-subjects with clinical signs of proximal myopathy (problems with standing up from chair or walking stairs)
- •-subjects seriously ill and unfit for participation in a clinical study (as judged by one of the study doctors)
- •-subjects using vitamin D supplements exceeding 800 IU per day or active vitamin D drugs (Rocaltrol or Etalpha)
研究者
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dHeart failure is a condition that occurs when the heart loses its normal ability to pump blood to maintain vital body functions and, therefore, works with lower efficiency. Several studies have shown that deficiency of vitamin D would delete the renin gene, regulate the myocytes growth and facilitate ventricular hypertrophy, favoring cardiovascular damage and the incidence of heart failure.MedDRA version: 14.1Level: SOCClassification code 10007541Term: Cardiac disordersSystem Organ Class: 10007541 - Cardiac disordersEUCTR2011-002823-16-ITA.O. UNIVERSITARIA INTEGRATA DI VERONA36