Study Results
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View full resultsBasic Information
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COMPLETED
NA
666 participants
INTERVENTIONAL
2017-01-11
2022-03-04
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Active Treatment
Vitamin D3
cholecalciferol (vitamin D3) 2000 IU capsules daily
Placebo
Placebo
Placebo
Interventions
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Vitamin D3
cholecalciferol (vitamin D3) 2000 IU capsules daily
Placebo
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
University of Washington
OTHER
Responsible Party
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Ian deBoer
Associate Professor, Medicine/Nephrology
Principal Investigators
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Ian de Boer
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Bryan Kestenbaum
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Locations
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University of California, Los Angeles
Los Angeles, California, United States
Northwestern University
Evanston, Illinois, United States
John Hopkins University
Baltimore, Maryland, United States
Columbia Univeristy
New York, New York, United States
Wake Forest University
Winston-Salem, North Carolina, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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STUDY00001485
Identifier Type: -
Identifier Source: org_study_id
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