Individualized Response to Vitamin D Treatment Study

Completed · Not applicable · Has a placebo group

Conditions studied: Characteristics That Modify the Response to Cholecalciferol Treatment

In brief

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.

Key facts

Study ID

NCT02925195

Run by

University of Washington

People needed

666

Starts

2017-01-11

Expected to finish

2022-03-04

Last updated by the study team

2023-11-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Current use of >1,000 international units (IU) of cholecalciferol daily
• Current use of any activated vitamin D product (calcitriol, paricalcitol, hectorol)
• Known history of allergy or adverse reaction to vitamin D treatment
• Known clinical history of primary hyperparathyroidism
• Known clinical history of kidney stones within the previous 5 years
• Current participation in another interventional study
• Inability to provide written informed consent

Where it is running

• University of California, Los Angeles — Los Angeles, California, United States
• Northwestern University — Evanston, Illinois, United States
• John Hopkins University — Baltimore, Maryland, United States
• Columbia Univeristy — New York, New York, United States
• Wake Forest University — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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