Effect of Vitamin D Oral Supplements on 25 OH Vitamin D Levels: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 279
- 试验地点
- 1
- 主要终点
- area under the curve of 25 OH vitamin D level
研究概览
简要总结
Vitamin D deficiency is common world wide. 25 OH vitamin D level is the best indicator of vitamin D status. Vitamin D supplements are available as vitamin D2 or D3, in small daily or large weekly/monthly doses. Controversy continues on the relative potency of vitamin D2 compared to D3 and of daily compared to weekly or monthly doses, in increasing/maintaining total 25 OH vitamin D level.
The investigators plan to conduct a controlled trial to compare the effect of various vitamin D supplements on 25 OH vitamin D levels in healthy adults with starting 25 OH vitamin D level between 20 to 50 nmol/L.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults living in Riyadh area who consume no more than one serving of milk/day, do not take vitamin supplement, habitually have less than 10 hr of sun exposure per week, don't suffer from granulomatous conditions, liver disease, or kidney disease, and don't take anticonvulsants, barbiturates, or steroids.
- •25 OH vitamin D level between 20 to 50 nmol/L.
排除标准
- 未提供
研究组 & 干预措施
placebo daily
干预措施: placebo orally everyday (Drug)
D2 25000 IU Q2wk
干预措施: ergocalciferol 25000 IU oraly every 2 weeks (Drug)
D3 25000 IU Q2wk
干预措施: Cholecalciferol 25000 IU orally every 2 weeks (Drug)
D2 50000 IU Q4wk
干预措施: ergocalciferol 50000 IU orally every 4 weeks (Drug)
D3 50000 IU Q4wk
干预措施: Cholecalciferol 50000 orally every 4 weeks (Drug)
D2 2000 IU daily
干预措施: ergocalciferol 2000 IU orally, daily (Drug)
D3 2000 IU daily
干预措施: cholecalciferol 2000 IU orally daily (Drug)
D2 1000 IU + D3 1000 IU daily
干预措施: ergocal1000 IU & cholecal 1000 IU orally daily (Drug)
结局指标
主要结局
area under the curve of 25 OH vitamin D level
时间窗: 140 days
area under the curve of total 25 OH vitamin D level from day 1 to 140
次要结局
- Cmax of 25 OH vitamin D(140 days)
- incidence of hypercalciuria(140 days)
- Tmax of 25 OH vitamin D level(140 days)
- area under the curve of vitamin D level(140 days)
- incidence of hypercalcemia(140 days)
研究者
Muhammad Maher Hammami
Chairman, Department of Clinical Studies & Empirical Ethics
King Faisal Specialist Hospital & Research Center