Clinical trial NCT02925195: Individualized Response to Vitamin D Treatment Study
Official title: Multi Ethnic Study of Atherosclerosis Individualized Response to Vitamin D Treatment Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Characteristics That Modify the Response to Cholecalciferol Treatment
Keywords: Vitamin D
cardiovascular disease
MESA
genetics
pharmacogenetics
blood pressure
biomarkers
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2016-10-05
Enrollment: 666
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change in Serum 1,25(OH)2D Concentration
timeFrame: 16 weeks
measure: Change in Serum PTH Concentration
timeFrame: 16 weeks
Secondary outcomes:
measure: Change in Systolic Blood Pressure
timeFrame: 16 weeks
measure: Change in Urine Calcium Excretion
timeFrame: 16 weeks
measure: Change in Serum Calcium Concentrations
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
city: Evanston
country: United States
facility: Northwestern University
state: Illinois
city: Baltimore
country: United States
facility: John Hopkins University
state: Maryland
city: New York
country: United States
facility: Columbia Univeristy
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest University
state: North Carolina
Study officials:
affiliation: University of Washington
name: Ian de Boer
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: Bryan Kestenbaum
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.