Individualized Response to Vitamin D Treatment Study

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.

Timeline

Start

2017-01-11

Primary completion

2021-11-30

Completion

2022-03-04

Publications

• Results Hsu S, Prince DK, Williams K, Allen NB, Burke GL, Hoofnagle AN, Li X, Liu KJ, McClelland RL, Michos ED, Psaty BM, Shea SJ, Rice KM, Rotter JI, Siscovick D, Tracy RP, Watson KE, Kestenbaum BR, de Boer IH. Clinical and biomarker modifiers of vitamin D treatment response: the Multi-Ethnic Study of Atherosclerosis. Am J Clin Nutr. 2022 Mar 4;115(3):914-924. doi: 10.1093/ajcn/nqab390.

Drugs

Indications