NCT02925195

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
666

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 3, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 5, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

January 11, 2017

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 4, 2022

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

November 2, 2023

Completed
Last Updated

November 2, 2023

Status Verified

October 1, 2023

Enrollment Period

4.9 years

First QC Date

October 3, 2016

Results QC Date

September 18, 2023

Last Update Submit

October 11, 2023

Conditions

Characteristics That Modify the Response to Cholecalciferol Treatment

Keywords

Vitamin Dcardiovascular diseaseMESAgeneticspharmacogeneticsblood pressurebiomarkers

Outcome Measures

Primary Outcomes (2)

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

    16 weeks

  • Change in Serum PTH Concentration

    16 weeks

Secondary Outcomes (3)

  • Change in Systolic Blood Pressure

    16 weeks

  • Change in Urine Calcium Excretion

    16 weeks

  • Change in Serum Calcium Concentrations

    16 weeks

Study Arms (2)

Active Treatment

EXPERIMENTAL
Dietary Supplement: Vitamin D3

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Vitamin D3DIETARY_SUPPLEMENT

cholecalciferol (vitamin D3) 2000 IU capsules daily

Active Treatment
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ,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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University of California, Los Angeles

Los Angeles, California, United States

Location

Northwestern University

Evanston, Illinois, United States

Location

John Hopkins University

Baltimore, Maryland, United States

Location

Columbia Univeristy

New York, New York, United States

Location

Wake Forest University

Winston-Salem, North Carolina, United States

Location

Related Publications (1)

  • Hsu S, Prince DK, Williams K, Allen NB, Burke GL, Hoofnagle AN, Li X, Liu KJ, McClelland RL, Michos ED, Psaty BM, Shea SJ, Rice KM, Rotter JI, Siscovick D, Tracy RP, Watson KE, Kestenbaum BR, de Boer IH. Clinical and biomarker modifiers of vitamin D treatment response: the Multi-Ethnic Study of Atherosclerosis. Am J Clin Nutr. 2022 Mar 4;115(3):914-924. doi: 10.1093/ajcn/nqab390.

    PMID: 34849546RESULT

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Cholecalciferol

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Results Point of Contact

Title
Dr. Ian de Boer
Organization
University of Washington
IDeBoer@Nephrology.washington.edu
206-616-5403

Study Officials

  • Ian de Boer

    University of Washington

    PRINCIPAL INVESTIGATOR

  • Bryan Kestenbaum

    University of Washington

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Medicine/Nephrology

Study Record Dates

First Submitted

October 3, 2016

First Posted

October 5, 2016

Study Start

January 11, 2017

Primary Completion

November 30, 2021

Study Completion

March 4, 2022

Last Updated

November 2, 2023

Results First Posted

November 2, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will share

Locations

US(5)