Vitamin D Deficiency
Conditions
Keywords
vitamin D, absorption, ezetimibe
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.
Interventions
DRUGEzetimibe
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.
DRUGCholecalciferol
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.
OTHERPlacebo
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.
Sponsors
Federal University of Rio Grande do Sul
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 25-hydroxyvitamin D | 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. |
Countries
Brazil
Outcome results
None listed