Skip to main content
OpenTrials
Completed

NCT Number: NCT02925195

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Characteristics That Modify the Response to Cholecalciferol Treatment Cardiovascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Los Angeles, Los Angeles, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Vitamin D3

Dietary Supplement

cholecalciferol (vitamin D3) 2000 IU capsules daily

Placebo

Drug

Primary outcomes

  1. Change in Serum 1,25(OH)2D Concentration

    Time frame: 16 weeks

  2. Change in Serum PTH Concentration

    Time frame: 16 weeks

Secondary outcomes

  1. Change in Systolic Blood Pressure

    Time frame: 16 weeks

  2. Change in Urine Calcium Excretion

    Time frame: 16 weeks

    Urine calcium excretion estimated as spot urine calcium-creatinine ratio

  3. Change in Serum Calcium Concentrations

    Time frame: 16 weeks

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Acronym: INVITE

Important dates

Study start
2017
Primary completion
2021
Study completion
2022
First posted
Oct 5, 2016
Registry last updated
Nov 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.