NCT00748618已完成不适用
Vitamin D Replacement After Kidney Transplant
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 2
- 主要终点
- Compare Efficacy and Safety of Two Vitamin D Supplements of These Doses in Normalizing Vitamin D Concentrations.
研究概览
简要总结
Vitamin D deficiency accelerates vascular risk progression after kidney transplant.
详细描述
This trial will assess the following aims:
- Time to plateau vitamin D concentrations after initiating vitamin D supplements
- Safety of vitamin D replacement based on serum and urine calcium
- Effect of vitamin D on PTH concentration in individuals with elevated parathyroid hormone
- Effect of vitamin D on markers of insulin resistance and inflammation
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Kidney transplant more than 6 months ago
- •19 years or older
- •25-hydroxy vitamin D ≤35 ng/ml
排除标准
- •Estimated Glomerular filtration rate (GFR) <30 ml/min/1.73m²
- •Previous small bowel or lung transplant
- •Pancreas transplant less than 6 months ago
- •Cancer or any condition that would change their weight dramatically in the near future such as malabsorption
- •Willing to return for testing every two months
- •Women who are pregnant or < 6 weeks postpartum
- •Calcium > 10.5 mg/dl
- •Phosphate > 4.8 mg/dl
- •Drinking more than 2 alcohol drinks a day or 14 drinks per week
- •History of parathyroid surgery
- •Known granulomatous disease
- •Taking any seizure medication that affects vitamin D
- •Taking Zemplar ® and/or Rocaltrol ®
- •History of kidney stones in the past 20 years
- •Not on a stable dose of bisphosphonate for the past three months
- •Planning on a pancreas transplant within the next year
- •In any other research study
结局指标
主要结局
Compare Efficacy and Safety of Two Vitamin D Supplements of These Doses in Normalizing Vitamin D Concentrations.
时间窗: Baseline and 6 months
The 6 month change (6 month - Baseline) was compared between the two treatment arms of vitamin D supplements for normalizing vitamin D concentrations. Higher change values indicate improvement in vitamin D levels.
次要结局
- The Ability of Vitamin D to Reduce Parathyroid Hormone Concentration.(baseline and 6 months)
- The Ability of Vitamin D to Alter Spot Urine Protein-Creatinine Ratio.(6 months)
- The Effect of Vitamin D Supplementation on 6 Month High-sensitivity C-reactive Protein (HsCRP) Levels.(Baseline and 6 months)
- The Effect of Vitamin D Supplementation on Insulin Resistance at 6 Months(Baseline and 6 months)
研究者
研究点 (2)
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