INVITE: Individualized Response to Vitamin D Treatment Study

Sponsor

University of Washington (Other)

Overall Status

Completed

CT.gov ID

NCT02925195

Collaborator

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

666

Enrollment

Locations

Arms

61.7

Actual Duration (Months)

133.2

Patients Per Site

2.2

Patients Per Site Per Month

Study Details

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	Phase
Characteristics That Modify the Response to Cholecalciferol Treatment	Dietary Supplement: Vitamin D3 Drug: Placebo	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

666 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 :

Jan 11, 2017

Actual Primary Completion Date :

Nov 30, 2021

Actual Study Completion Date :

Mar 4, 2022

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Active Treatment

Dietary Supplement: Vitamin D3

cholecalciferol (vitamin D3) 2000 IU capsules daily

Placebo Comparator: Placebo

Placebo

Drug: Placebo

Outcome Measures

Primary Outcome Measures

Change in serum 1,25(OH)2D concentration [16 weeks]
Change in serum PTH concentration [16 weeks]

Secondary Outcome Measures

Change in blood pressure [16 weeks]
Change in urine calcium concentrations [16 weeks]
Change in serum calcium concentrations [16 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country
1	University of California, Los Angeles	Los Angeles	California	United States
2	Northwestern University	Evanston	Illinois	United States
3	John Hopkins University	Baltimore	Maryland	United States
4	Columbia Univeristy	New York	New York	United States
5	Wake Forest University	Winston-Salem	North Carolina	United States