Magnitude of Changes in 25 OH Vitamin D3 Levels After Vitamin D3 Supplementation: A Randomized Controlled Study
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Slope of 25 OH vitamin D3 level vs vitamin D3 dose
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. The determination of the appropriate dose of vitamin D supplement is essential for management of vitamin D deficiency as well as for designing vitamin D fortification programs. The increments in 25 OH vitamin D levels following various doses of vitamin D supplement for different genders, body weights, and starting 25 OH vitamin D level have not been well defined. The time course of depletion of repleted vitamin D stores is also not known.
The investigators plan to conduct a double blind randomized study on 9 cohorts to determine levels of 25 OH vitamin D following supplementation with different doses of vitamin D3 for 5 months and their withdrawal for 3 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
- 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
- •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.
- •Individuals with with total 25 OH vitamin D level exceeding 100 nmol/l will be excluded from the study. Individuals with 25 OH vitamin D levels less than 20 nmol/L will be excluded from the placebo arm.
排除标准
- 未提供
研究组 & 干预措施
vitamin D3 1000 IU
干预措施: vitamin D3 1000 IU orally daily for 5 months (Drug)
Vitamin D3 3000 IU
干预措施: vitamin D3 3000 IU orally daily for 5 months (Drug)
Vitamin D3 5000 IU
干预措施: vitamin D3 5000 IU orally daily for 5 months (Drug)
Placebo
干预措施: Placebo orally daily for 5 months (Drug)
结局指标
主要结局
Slope of 25 OH vitamin D3 level vs vitamin D3 dose
时间窗: 5 months
The primary endpoint is the slope of the dose (vitamin D3)- response (25 OH vitamin D3 level) curve for each cohort. The slope of the placebo group will be used to determine changes in 25 OH vitamin D3 levels that are not related to study intervention. The slope will be determined over 5 months.
次要结局
- slope of vitamin D3 level vs vitamin D3 dose(5 months)
- incidence of hypercalcemia(8 months)
- incidence of hypercalciuria(8 months)
- slope of decline of 25 OH vitamin D3 level vs time(3 months)
研究者
Muhammad Maher Hammami
Chairman, Department of Clinical Studies & Empirical Ethics
King Faisal Specialist Hospital & Research Center