NCT02830789已完成不适用
Investigation of the Optimal Calcium Supplement Following Roux-en-Y Gastric Bypass in Order to Treat Secondary Hyperparathyroidism: A Clinical Randomized Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Parathyroid Hormone
研究概览
简要总结
This study investigates whether calcium citrate or calcium carbonate are the optimal supplement to treat secondary hyperparathyroidism following Roux-en-Y gastric bypass operation.
Half of the participants will be randomized to receive calcium citrate, while the other half will receive calcium carbonate. The study will be double blinded.
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
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Roux-en-Y gastric bypass operation ≥12 months ago
- •Parathyroid hormone > 6.9 pmol/l
- •Vitamin D > 50 nmol/l
- •P-Calcium [1.18-1.32] mmol/l
排除标准
- •Liver disease
- •Renal disease
- •Hypercalcemia
- •Untreated thyroid disease
- •Parathyroid disease except secondary hyperparathyroidism
- •Use of diuretics, bisphosphonates, calcitonin, teriparatide, oral corticosteroids, anabolic steroids, calcimimetics, lithium, strontium, denosumab or anticonvulsants within 1 year of inclusion
- •abusing alcohol
结局指标
主要结局
Parathyroid Hormone
时间窗: Change from baseline at 6 weeks and 12 weeks
次要结局
- Se-ion-calcium(Change from baseline at 6 weeks and 12 weeks)
- P-25-OH-vitamin D(Change from baseline at 6 weeks and 12 weeks)
- P-calcitriol(Change from baseline at 6 weeks and 12 weeks)
- 24h U-calcium(Change from baseline at 12 weeks)
- P-magnesium(Change from baseline at 6 weeks and 12 weeks)
- Vitamin D binding protein(Change from baseline at 6 weeks and 12 weeks)
- P-bone specific alkaline phosphatase(Change from baseline at 6 weeks and 12 weeks)
- 24h U-phosphate(Change from baseline at 12 weeks)
- P-phosphate(Change from baseline at 6 weeks and 12 weeks)
- P-24,25-(OH)2-vitamin D(Change from baseline at 6 weeks and 12 weeks)
- Procollagen type 1 N-terminal propeptide (P1NP)(Change from baseline at 6 weeks and 12 weeks)
- Cross-linked C-telopeptide (CTX)(Change from baseline at 6 weeks and 12 weeks)
研究者
Lene Ring Madsen
PhD student, MD
University of Aarhus
研究点 (2)
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