NCT00674154已完成2 期
Effect of Vitamin D Treatment in Primary Hyperparathyroidism
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Decrease in Preoperative P-PTH
研究概览
简要总结
The primary aim of the study is to assess whether 6-months of vitamin D supplements can decrease PTH compared with placebo treatment in primary hyperparathyroidism.
详细描述
The study investigates effects and safety of six months of vitamin D supplementation before and after surgery in primary hyperparathyroidism. Effects are assessed as changes in calcium homeostasis, bone metabolism, quality of life, and muscle strength and function.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •P-Ca-ion > 1,30 mmol/l
- •P-PTH > 5 pmol/l
- •P-OH25-vitamin D < 80 nmol/l
排除标准
- •P-creatinin > 120 mumol/l
- •usage of Etalpha, Mimpara
- •Sarcoidosis
- •malabsorption
- •pancreatitis
- •alcohol abuse
- •pregnancy
研究组 & 干预措施
Vitamin D group
Experimental
Cholecalciferol 1400 IU, 2 tablets once daily in 52 weeks
干预措施: Cholecalciferol (Drug)
Placebo group
Placebo Comparator
Placebo, two tablets daily in 52 weeks.
干预措施: Cholecalciferol (Drug)
结局指标
主要结局
Decrease in Preoperative P-PTH
时间窗: 25 weeks
Decrease in plasma PTH after 25 weeks of preoperative vitamin D treatment compared with the plasebo Group.
次要结局
- Increased Bone Mineral Density(One year)
- Increase in Quality of Life(One year)
- Improved Muscular Function(One Year)
- Reduced Postoperative Hypocalcemia(Postoperative week)
- Increase in Trabecular and Cortical vBMD Measured by QCT and pQCT of Hip, Spine and Forearm(one year)
研究者
研究点 (1)
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