CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 666 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02925195
NCT02925195N/ACompleted

Multi Ethnic Study of Atherosclerosis Individualized Response to Vitamin D Treatment Study

University of Washington·interventional·Posted Oct 5, 2016·Updated Nov 2, 2023

In Brief

A clinical study evaluating Vitamin D3 and Placebo for Characteristics That Modify the Response to Cholecalciferol Treatment. Completed, enrolled 666 participants across 5 sites.

Detailed Summary

The goal of this clinical trial is to determine individual-level genetic and metabolic characteristics that modify the response to cholecalciferol treatment. This study is double blind, parallel design, randomized clinical trial that will assess genetic and metabolic characteristics that modify the response to cholecalciferol treatment. . Eligible participants will be randomly assigned to receive cholecalciferol treatment (2,000 international units of cholecalciferol daily by mouth) or placebo in a 3:1 ratio for a total duration of 16-weeks. The planned sample size is 1,600. The primary aim of this study is to identify genetic polymorphisms, clinical characteristics, and biomarkers that modify the biologic response to vitamin D3 treatment, assessed by changes in serum concentrations of parathyroid hormone (PTH) and 1,25(OH)2D and urine calcium excretion.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedOct 5, 2016
Enrollment StartJan 11, 2017
Primary CompletionNov 30, 2021
Study CompletionMar 4, 2022
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 9.7 years ago

Interventions

Vitamin D3dietary

cholecalciferol (vitamin D3) 2000 IU capsules daily

Placebodrug