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临床试验/NCT01477801
NCT01477801Unknown2 期

Effects of Cholecalciferol Supplementation in Patients With Chronic Heart Failure and LOw vITamind D Levels. A Phase 2 Randomized Double Blind Study

Azienda Unita' Sanitaria Locale Di Modena1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2011年11月最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
2 期
入组人数
34
试验地点
1
主要终点
SIX MINUTE WALKING TEST DISTANCE
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to determine whether cholecalciferol supplementation in patients with chronic heart failure and low vitamin D levels improves:

  1. performance at six minutes walking test
  2. echocardiographic parameters
  3. neurohormonal imbalance

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
60 Years 至 —（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Heart failure diagnosis according to European Society of Cardiology Guideline criteria
  • •Age > 60 years old
  • •25(OH) Vitamin D level < 30 ng/ml
  • •Clinical and therapeutic stability for one month (NYHA class II or III)

排除标准

  • •Chronic use of anticonvulsants or barbiturates, steroids, thiazides, aluminium or magnesium, colestipol or cholestyramine
  • •Glomerular filtration rate lower than 30 ml/min/1.73 m2 according to MDRD equation
  • •Nephrolitiasis, Sarcoidosis or hypercalcemia
  • •Recent (three months) acute coronary syndrome or stroke or major vascular surgery
  • •Reduced life expectancy due to other diseases (active neoplasms, liver cirrhosis...)

研究组 & 干预措施

CHOLECALCIFEROL

Experimental

干预措施: CHOLECALCIFEROL (Drug)

PLACEBO

Placebo Comparator

干预措施: PLACEBO (Drug)

结局指标

主要结局

SIX MINUTE WALKING TEST DISTANCE

时间窗: six months

次要结局

  • ECHOCARDIOGRAPHIC PARAMETERS(six months)
  • NEUROHORMONAL CHANGES(six months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

TURRINI FABRIZIO

MD

Azienda Unita' Sanitaria Locale Di Modena

研究点 (1)

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