Treatment of Vitamin D Deficiency With Large Bolus Cholecalciferol in the Outpatient Setting
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Efficacy of treatment of vitamin D deficiency over a one year time frame: normalization of vitamin D levels above 30ng/mL
研究概览
简要总结
Comparing two treatment regimens (solitary large dose vs daily smaller dose) in patients diagnosed with vitamin D deficiency.
详细描述
Study is looking at patients with diagnosed vitamin D deficiency (<20ng/mL). Participants are healthy adults between 18 and 75. No diagnosis of cancer, pregnancy, hypercalcemia, hyperparathyroidism, gastrointestinal absorption disorder, or chronic kidney disease and not taking medications for seizures or osteoporosis. Participants are randomized into two treatment groups: (1) 5,000IU cholecalciferol daily or (2) one-time 300,000 international units (IU) cholecalciferol. Vitamin D level, calcium level, and renal function are measure one week after initiating treatment and then at 3 months, 6 months, 9 months, and 12 months.
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
- None
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
- •age 18-75yrs old
- •serum 25(OH)-vitamin D level <20ng/mL
- •patient of Parkview Adult Medicine clinic
- •not currently on cholecalciferol >2,000IU daily
- •no ergocalciferol administration within last week
排除标准
- •history of hypercalcemia or hyperparathyroidism
- •history of chronic kidney disease with baseline creatinine >1.1
- •history of gastric absorption abnormalities
- •history of Paget's disease or osteomalacia
- •history of thyrotoxicosis
- •known malignancy
- •currently pregnant
- •taking medications for osteoporosis or seizures
- •taking more than 1200mg/day of calcium
- •inpatient hospitalization at the initiation of study meds
研究组 & 干预措施
Large bolus
干预措施: Cholecalciferol (Drug)
Standard
干预措施: Cholecalciferol (Drug)
结局指标
主要结局
Efficacy of treatment of vitamin D deficiency over a one year time frame: normalization of vitamin D levels above 30ng/mL
时间窗: 12months
Looking for normalization of vitamin D levels
次要结局
- Duration of efficacy after starting vitamin D replacement as monitored at one week and then three month intervals for one year(1 week, 3 months, 6 months, 9 months, 12 months)
- Compliance with therapy as measured by the reported number of missed doses at one week on therapy and then every three months for a year(1 week, 3 months, 6 months, 9 months, 12 months)
研究者
Doug Duffee
Administrator
Parkview Medical Center