NCT02234544

Effect of an Inhibitor of Cholesterol Absorption on Vitamin D Levels

Estudo clínico Randomizado, Controlado e Duplo-cego do Impacto da inibição de um Transportador de Membrana do Colesterol na absorção da Vitamina D

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Federal University of Rio Grande do Sul · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Vitamin D Deficiency

Interventions

Type	Name	Description
DRUG	Ezetimibe	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.
DRUG	Cholecalciferol	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	Placebo	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.

Timeline

• Start date: 2014-10-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2014-09-09
• Last updated: 2015-04-09

Locations

1 site across 1 country: Brazil