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

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.

Study Overview

• Status: Completed
• Conditions: Vitamin D Deficiency
• Intervention / Treatment: Drug: Cholecalciferol; Other: Placebo; Drug: Ezetimibe

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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • RS
    • Porto Alegre, RS, Brazil, 90035-903
      • Hospital de Clinicas de Porto Alegre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo + Cholecalciferol; The groups will be randomized to ezetimibe or placebo. All participants will receive orally a cholecalciferol capsule.	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 Names: Vitamin D; 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.
Active Comparator: Ezetimibe + Cholecalciferol; The groups will be randomized to ezetimibe or placebo. All participants will receive orally a cholecalciferol capsule.	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 Names: Vitamin D; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
25-hydroxyvitamin D	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.	up to 24 months

Collaborators and Investigators

• Sponsor: Federal University of Rio Grande do Sul

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: August 31, 2014
• First Submitted That Met QC Criteria: September 8, 2014
• First Posted (Estimate): September 9, 2014

Study Record Updates

• Last Update Posted (Estimate): April 9, 2015
• Last Update Submitted That Met QC Criteria: April 7, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: vitamin D; absorption; ezetimibe
• Additional Relevant MeSH Terms: Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Vitamin D Deficiency; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Micronutrients; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol; Ezetimibe
• Other Study ID Numbers: 14-0378