Clinical trial NCT02234544: Effect of an Inhibitor of Cholesterol Absorption on Vitamin D Levels
Official title: Estudo clínico Randomizado, Controlado e Duplo-cego do Impacto da inibição de um Transportador de Membrana do Colesterol na absorção da Vitamina D
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vitamin D Deficiency
Keywords: vitamin D
absorption
ezetimibe
Lead sponsor: Federal University of Rio Grande do Sul
Sponsor class: OTHER
First posted: 2014-09-09
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Medical students of the HCPA

Exclusion Criteria:

* 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

Primary outcomes:
measure: 25-hydroxyvitamin D
timeFrame: up to 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: RS
Study officials:
References:
citation: Silva MC, Faulhauber GAM, Leite EN, Goulart KR, Ramirez JMA, Cocolichio FM, Furlanetto TW. Impact of a cholesterol membrane transporter's inhibition on vitamin D absorption: A double-blind randomized placebo-controlled study. Bone. 2015 Dec;81:338-342. doi: 10.1016/j.bone.2015.07.022. Epub 2015 Jul 21.