Characteristics That Modify the Response to Cholecalciferol TreatmentINVITENCT02925195

Individualized Response to Vitamin D Treatment Study

A study testing Vitamin D3 in people with Characteristics That Modify the Response to Cholecalciferol Treatment, run by University of Washington at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Characteristics That Modify the Response to Cholecalciferol Treatment
What is being tested?: Vitamin D3
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 666 participants
Where: 5 sitesUnited States
Study dates: 11 Jan 2017to 4 Mar 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

John Hopkins University
Baltimore, Maryland
Northwestern University
Evanston, Illinois
University of California, Los Angeles
Los Angeles, California
Columbia Univeristy
New York, New York
Wake Forest University
Winston-Salem, North Carolina

Other trials in United States

About this study

Official title: Multi Ethnic Study of Atherosclerosis 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.

Conditions: Characteristics That Modify the Response to Cholecalciferol Treatment
Being tested: Vitamin D3, Placebo
Keywords: Vitamin D, cardiovascular disease, MESA, genetics, pharmacogenetics, blood pressure, biomarkers
Medical subject headings: Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Vitamin D3Dietary supplement
cholecalciferol (vitamin D3) 2000 IU capsules daily
PlaceboDrug

Study groups in NCT02925195
Study group	Role	What they receive
Active Treatment	Experimental	Not described Receives: Dietary Supplement: Vitamin D3
Placebo	Placebo comparator	Placebo Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Serum 1,25(OH)2D Concentration
Measured: 16 weeks
Change in Serum PTH Concentration
Measured: 16 weeks

Secondary outcomes (3)

Change in Systolic Blood Pressure
Measured: 16 weeks
Change in Urine Calcium Excretion
Urine calcium excretion estimated as spot urine calcium-creatinine ratio
Measured: 16 weeks
Change in Serum Calcium Concentrations
Measured: 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Jan 20174 Mar 2022

First posted5 Oct 2016 (estimated)
Study start11 Jan 2017
Primary completion30 Nov 2021
Study completion4 Mar 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Characteristics That Modify the Response to Cholecalciferol TreatmentStudies of the same condition, open and under way.
More trials run by University of WashingtonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 666 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02925195
Sponsor's protocol ID: STUDY00001485
Other IDs: R01HL096875
Acronym: INVITE
Status last verified: Oct 2023
First submitted: 3 Oct 2016
Last updated: 2 Nov 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes

Publications

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.
PubMed 34849546

Study at a glance

From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multi Ethnic Study of Atherosclerosis Individualized Response to Vitamin D Treatment Study
ClinicalTrials.gov ID: NCT02925195
Acronym / sponsor ID: INVITE / STUDY00001485
Conditions: Characteristics That Modify the Response to Cholecalciferol Treatment
Keywords: Vitamin D, cardiovascular disease, MESA, genetics, pharmacogenetics, blood pressure, biomarkers
Study type: Interventional
Recruitment status: Completed
Enrolment: 666 participants (actual)
Lead sponsor: University of WashingtonUniversity, hospital or other
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Study start: 11 Jan 2017 (actual)
Primary completion: 30 Nov 2021 (actual)
Study completion: 4 Mar 2022 (actual)
First posted: 5 Oct 2016 (estimated)
Results: Posted 2 Nov 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The goal of this clinical trial is to determine individual-level genetic and metabolic characteristics that modify the response to cholecalciferol treatment.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Active Treatment	Experimental	Dietary Supplement: Vitamin D3
Placebo	Placebo comparator	Drug: PlaceboPlacebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Vitamin D3cholecalciferol (vitamin D3) 2000 IU capsules daily	Dietary supplement	Active Treatment
Placebo	Drug	Placebo

Primary outcome

Change in Serum 1,25(OH)2D Concentration
Time frame: 16 weeks
Change in Serum PTH Concentration
Time frame: 16 weeks

3 secondary outcomes

Change in Systolic Blood Pressure
Time frame: 16 weeks
Change in Urine Calcium Excretion
Time frame: 16 weeks
Change in Serum Calcium Concentrations
Time frame: 16 weeks

Results and safety

Results posted to the registry on 2 Nov 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Active Treatment	499	453
Placebo	167	158

Primary outcome: Change in Serum 1,25(OH)2D Concentration

Time frame: 16 weeks. Mean (Standard Deviation). Unit: pg/mL

Measure	Active Treatment n = 499	Placebo n = 167
Value	2 (16)	-1 (17)

Primary outcome: Change in Serum PTH Concentration

Time frame: 16 weeks. Mean (Standard Deviation). Unit: pg/mL

Measure	Active Treatment n = 499	Placebo n = 167
Value	-3 (16)	2 (18)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 16 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active Treatment	2 of 499 (0.4%)	55 of 499 (11%)	1 of 499
Placebo	2 of 167 (1.2%)	16 of 167 (9.6%)	0 of 167

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 34849546Hsu 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.
Individual participant dataSharing planned: Yes

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ian de Boer principal investigator

University of Washington

Bryan Kestenbaum principal investigator

University of Washington

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Vitamin D3 in people with Characteristics That Modify the Response to Cholecalciferol Treatment, run by University of Washington at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Serum 1,25(OH)2D Concentration (time frame: 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02925195, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2023; AzTrials last refreshed its copy on 26 Oct 2026.