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Trial record 2 of 161 for:    InVite

Individualized Response to Vitamin D Treatment Study (INVITE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02925195
Recruitment Status : Enrolling by invitation
First Posted : October 5, 2016
Last Update Posted : May 19, 2017
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Characteristics That Modify the Response to Cholecalciferol Treatment Dietary Supplement: Vitamin D3 Drug: Placebo

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multi Ethnic Study of Atherosclerosis Individualized Response to Vitamin D Treatment Study
Actual Study Start Date : January 11, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Active Treatment Dietary Supplement: Vitamin D3
cholecalciferol (vitamin D3) 2000 IU capsules daily
Placebo Comparator: Placebo
Drug: Placebo

Outcome Measures

Primary Outcome Measures :
  1. Change in serum 1,25(OH)2D concentration [ Time Frame: 16 weeks ]
  2. Change in serum PTH concentration [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  1. Change in blood pressure [ Time Frame: 16 weeks ]
  2. Change in urine calcium concentrations [ Time Frame: 16 weeks ]
  3. Change in serum calcium concentrations [ Time Frame: 16 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02925195

United States, Illinois
Northwestern University
Evanston, Illinois, United States
United States, Maryland
John Hopkins University
Baltimore, Maryland, United States
United States, New York
Columbia Univeristy
New York, New York, United States
United States, North Carolina
Wake Forest University
Winston-Salem, North Carolina, United States
Sponsors and Collaborators
University of Washington
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Ian de Boer University of Washington
Principal Investigator: Bryan Kestenbaum University of Washington
More Information

Responsible Party: Ian deBoer, Associate Professor, Medicine/Nephrology, University of Washington
ClinicalTrials.gov Identifier: NCT02925195     History of Changes
Other Study ID Numbers: STUDY00001485
R01HL096875 ( U.S. NIH Grant/Contract )
First Posted: October 5, 2016    Key Record Dates
Last Update Posted: May 19, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ian deBoer, University of Washington:
Vitamin D
cardiovascular disease
blood pressure

Additional relevant MeSH terms:
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents