NCT02234544

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2014

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 9, 2014

Completed
22 days until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

April 9, 2015

Status Verified

April 1, 2015

Enrollment Period

6 months

First QC Date

August 31, 2014

Last Update Submit

April 7, 2015

Conditions

Vitamin D Deficiency

Keywords

vitamin Dabsorptionezetimibe

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Placebo + Cholecalciferol

PLACEBO COMPARATOR

The groups will be randomized to ezetimibe or placebo. All participants will receive orally a cholecalciferol capsule.

Drug: CholecalciferolOther: Placebo

Ezetimibe + Cholecalciferol

ACTIVE COMPARATOR

The groups will be randomized to ezetimibe or placebo. All participants will receive orally a cholecalciferol capsule.

Drug: EzetimibeDrug: Cholecalciferol

Interventions

EzetimibeDRUG

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.

Ezetimibe + Cholecalciferol
CholecalciferolDRUG

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.

Also known as: Vitamin D
Ezetimibe + CholecalciferolPlacebo + Cholecalciferol
PlaceboOTHER

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.

Placebo + Cholecalciferol

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Medical students of the HCPA

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 26208795DERIVED

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

EzetimibeCholecalciferolVitamin D

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

AzetidinesAzetinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsSecosteroidsMembrane LipidsLipids

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, MSc

Study Record Dates

First Submitted

August 31, 2014

First Posted

September 9, 2014

Study Start

October 1, 2014

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

April 9, 2015

Record last verified: 2015-04

Locations

BR(1)