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Trial record 2 of 151 for:    InVite

Individualized Response to Vitamin D Treatment Study (INVITE)

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Ian deBoer, University of Washington
ClinicalTrials.gov Identifier:
NCT02925195
First received: October 3, 2016
Last updated: May 17, 2017
Last verified: May 2017
  Purpose

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 Intervention
Characteristics That Modify the Response to Cholecalciferol Treatment Dietary Supplement: Vitamin D3 Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: Multi Ethnic Study of Atherosclerosis Individualized Response to Vitamin D Treatment Study

Resource links provided by NLM:


Further study details as provided by Ian deBoer, University of Washington:

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

Secondary Outcome Measures:
  • Change in blood pressure [ Time Frame: 16 weeks ]
  • Change in urine calcium concentrations [ Time Frame: 16 weeks ]
  • Change in serum calcium concentrations [ Time Frame: 16 weeks ]

Estimated Enrollment: 1600
Actual Study Start Date: January 11, 2017
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active Treatment Dietary Supplement: Vitamin D3
cholecalciferol (vitamin D3) 2000 IU capsules daily
Placebo Comparator: Placebo
Placebo
Drug: Placebo

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02925195

Locations
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)
Investigators
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 )
Study First Received: October 3, 2016
Last Updated: May 17, 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
MESA
genetics
pharmacogenetics
blood pressure
biomarkers

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

ClinicalTrials.gov processed this record on July 28, 2017