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Individualized Response to Vitamin D Treatment Study

NCT02925195 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 666

Last updated 2023-11-02

Study results available
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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.

Conditions

  • Characteristics That Modify the Response to Cholecalciferol Treatment

Interventions

DIETARY_SUPPLEMENT

Vitamin D3

cholecalciferol (vitamin D3) 2000 IU capsules daily

DRUG

Placebo

Sponsors & Collaborators

Principal Investigators

  • Ian de Boer · University of Washington

  • Bryan Kestenbaum · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-11
Primary Completion
2021-11-30
Completion
2022-03-04

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02925195 on ClinicalTrials.gov