Estudo clínico Randomizado, Controlado e Duplo-cego do Impacto da inibição de um Transportador de Membrana do Colesterol na absorção da Vitamina D
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- 25-hydroxyvitamin D
研究概览
简要总结
Double-blind randomized controlled trial to evaluate the serum levels of 25(OH)D after a single oral dose of cholecalciferol 50,000 IU plus ezetimibe or placebo.
Differences between the serum levels of 25(OH)D in response to cholecalciferol plus ezetimibe compared to cholecalciferol plus placebo.
详细描述
Objectives: To evaluate the serum levels of 25(OH)D after a single oral dose of cholecalciferol 50,000 IU plus ezetimibe or placebo.
Experimental design: Double-blind randomized controlled trial. Research location: Porto Alegre Clinical Hospital (HCPA), RS, Brazil. Participants: Medical residents of the HCPA. Intervention: The groups will be randomized to ezetimibe 10 mg for 5 days or placebo. On the fifth day, they should came after an overnight fast for blood tests collection [25(OH)D, PTH, calcium, albumin]. Next, all participants will receive orally a cholecalciferol 50,000 IU capsule and a snack containing 15g of fat. Participants will return 14 days after that for a second blood test.
Statistical Analysis
Paired samples t-test or Wilcoxon signed rank-test will be used for comparing variables in two distinct moments (before cholecalciferol and 14 days after). The correlation between the numerical variables will be evaluated by the Spearman's correlation coefficient. A p value of less than 0.05 was considered statistically significant.
Expected results: Differences between the serum levels of 25(OH)D in response to cholecalciferol plus ezetimibe compared to cholecalciferol plus placebo.
Cost/benefit of the project: This is a low budget and minimal risks study that will contribute to a better understanding of the absorptive process of vitamin D and the effect of ezetimibe on its absorption.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Medical students of the HCPA
排除标准
- •Body mass index >+ 25 or < 18.5 kg/m2
- •Known liver, kidney or endocrine disease
- •Known malabsorption
- •Use of supplements of calcium and/or vitamin Danticonvulsants, barbiturates, or glucocorticoids
- •Travel outside the Brazilian south region during the previous 120 days
研究组 & 干预措施
Placebo + Cholecalciferol
The groups will be randomized to ezetimibe or placebo. All participants will receive orally a cholecalciferol capsule.
干预措施: Cholecalciferol (Drug)
Placebo + Cholecalciferol
The groups will be randomized to ezetimibe or placebo. All participants will receive orally a cholecalciferol capsule.
干预措施: Placebo (Other)
Ezetimibe + Cholecalciferol
The groups will be randomized to ezetimibe or placebo. All participants will receive orally a cholecalciferol capsule.
干预措施: Ezetimibe (Drug)
Ezetimibe + Cholecalciferol
The groups will be randomized to ezetimibe or placebo. All participants will receive orally a cholecalciferol capsule.
干预措施: Cholecalciferol (Drug)
结局指标
主要结局
25-hydroxyvitamin D
时间窗: up to 24 months
The groups will be randomized to ezetimibe 10 mg for 5 days or placebo. On the fifth day, they should came after an overnight fast for blood tests collection \[25(OH)D, PTH, calcium, albumin\]. Next, all participants will receive orally a cholecalciferol 50,000 IU capsule and a snack containing 15g of fat. Participants will return 14 days after that for a second blood test.
次要结局
未报告次要终点
研究者
Mariana Costa Silva
MD, MSc
Federal University of Rio Grande do Sul