Effect of an Inhibitor of Cholesterol Absorption on Vitamin D Levels
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Ezetimibe; Cholecalciferol; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): 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.; 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.; 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.
Other intervention name(s): Vitamin D
Intervention MeSH terms: Vitamin D; Cholecalciferol; Ezetimibe
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: vitamin D; absorption; ezetimibe