Impact of Vitamin D Supplementation on Cardiac Hypertrophy and Function in Chronic Kidney Disease Patients - a Randomised Controlled Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Left ventricular mass
研究概览
简要总结
Patients with Chronic Kidney Disease (CKD) are upto 3.5 times more likely to die from diseases of heart and blood vessels (Cardiovascular Disease-CVD). Vitamin D insufficiency is very common in CKD and associated with CVD. Animal studies have shown an improvement in heart size and function with Vitamin D therapy, although evidence in humans is lacking. The proposed study will test if oral Vitamin D treatment, in deficient CKD patients, will improve heart enlargement and function. With these proposed changes the investigators expect to reduce CVD and deaths in patients with CKD.
详细描述
Impact of Vitamin D supplementation on Cardiac Hypertrophy and Function in Chronic Kidney Disease Patients- A randomised placebo controlled trial.
- Lay summary:
Patients with Chronic Kidney Disease (CKD) are up to 3.5 times more likely to die from diseases of heart and blood vessels (Cardiovascular Disease-CVD). Vitamin D insufficiency is very common in CKD and associated with CVD. Animal studies have shown an improvement in heart size and function with Vitamin D therapy, although evidence in humans is lacking. The proposed study will test if oral Vitamin D treatment, in deficient CKD patients, will improve heart enlargement and function. With these proposed changes the investigators expect to reduce CVD and deaths in patients with CKD. 2. Abstract of proposed investigation:
Traditional risk factors inadequately explain the disproportionate increase in CV risk in CKD. Hypovitaminosis D is common in CKD and associated with increased CV mortality. In animal experiments, vitamin D reduces LV mass (LVM) and improves systolic function. In dialysis patients, observational studies show that vitamin D therapy reduces CV mortality and improves diastolic function. However, benefit of native vitamin D repletion on cardiac structure and function has not been investigated in humans.
The investigators propose to test in a randomised, placebo-controlled trial, if 40 weeks of oral Colecalciferol, in predialysis CKD patients, will result in reduction of LV mass and improvement in systolic/diastolic function along with cardiac extracellular matrix composition.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •50 adult (18-75 years old)
- •patients with estimated GFR between 15-45 ml/min/1.73 m2 (CKD stage 3b and 4) on ACE inhibitors and/or ARB therapy will be recruited.
排除标准
- •The following patients will be excluded from the trial:
- •patients with diabetes mellitus
- •Hb < 10gm% or on EPO
- •serum calcium > 2.55 mmol/L
- •known malignancies
- •patients on vitamin D supplementation
- •heart failure (ejection fraction < 40 or pro NT BNP > 500 pg/ml
- •uncontrolled hypertension (BP > 150/90 mmHg)
- •patients with AV fistula for dialysis access
- •significant valvular heart disease
- •conditions that may influence collagen metabolism such as recent (< 6months) surgery or trauma
- •fibrotic diseases or active inflammatory conditions
- •history of myocardial infarction and/or Troponin T > 0.5
结局指标
主要结局
Left ventricular mass
时间窗: 52 weeks
次要结局
- Cardiac systolic and diastolic function(52 weeks)