Individualized Response to Vitamin D Treatment Study



Status:Enrolling by invitation
Healthy:No
Age Range:18 - Any
Updated:10/13/2018
Start Date:January 11, 2017
End Date:December 2018

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Trial Summary
Trial Overview
Inclusion Criteria

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

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.


Inclusion Criteria:

1,600 participants from the Multi-Ethnic Study of Atherosclerosis (MESA) study who are
returning for their scheduled 6th MESA study visit.

Participants will be recruited from four field centers: Wake Forest University,
Winston-Salem, NC; Columbia University, New York, NY; Northwestern University, Evanston,
IL; and Johns Hopkins University, Baltimore, MD.

Exclusion Criteria:

1. Current use of >1,000 international units (IU) of cholecalciferol daily

2. Current use of any activated vitamin D product (calcitriol, paricalcitol, hectorol)

3. Known history of allergy or adverse reaction to vitamin D treatment

4. Known clinical history of primary hyperparathyroidism

5. Known clinical history of kidney stones within the previous 5 years

6. Current participation in another interventional study

7. Inability to provide written informed consent
We found this trial at
5
sites
John Hopkins University
1101 East 33rd Street
Baltimore, Maryland 21287
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University of California at Los Angeles
Los Angeles, California 90095
310-825-4321
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
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Northwestern University
Evanston, Illinois 60208
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Evanston, IL
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Columbia Univeristy
New York, New York 10032
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New York, NY
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Wake Forest University
Winston-Salem, North Carolina 27157
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Winston-Salem, NC
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