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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL096875 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Treatment | Experimental |
| |
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D3 | Dietary Supplement | cholecalciferol (vitamin D3) 2000 IU capsules daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Serum 1,25(OH)2D Concentration | 16 weeks | |
| Change in Serum PTH Concentration | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Systolic Blood Pressure | 16 weeks | |
| Change in Urine Calcium Excretion | Urine calcium excretion estimated as spot urine calcium-creatinine ratio | 16 weeks |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Ian de Boer | University of Washington | Principal Investigator |
| Bryan Kestenbaum | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Los Angeles | Los Angeles | California | United States | |||
| Northwestern University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34849546 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Treatment | Vitamin D3: cholecalciferol (vitamin D3) 2000 IU capsules daily |
| FG001 | Placebo | Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Treatment | Vitamin D3: cholecalciferol (vitamin D3) 2000 IU capsules daily |
| BG001 | Placebo | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Serum 1,25(OH)2D Concentration | Posted | Mean | Standard Deviation | pg/mL | 16 weeks |
|
|
16 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Treatment | Vitamin D3: cholecalciferol (vitamin D3) 2000 IU capsules daily |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diverticulosis | Gastrointestinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac disorders | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ian de Boer | University of Washington | 206-616-5403 | IDeBoer@Nephrology.washington.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 5, 2018 | Sep 18, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Placebo |
| Drug |
|
| Change in Serum Calcium Concentrations | 16 weeks |
| 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 |
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
|
| Primary | Change in Serum PTH Concentration | Posted | Mean | Standard Deviation | pg/mL | 16 weeks |
|
|
|
| Secondary | Change in Systolic Blood Pressure | Posted | Mean | Standard Deviation | mmHg | 16 weeks |
|
|
|
| Secondary | Change in Urine Calcium Excretion | Urine calcium excretion estimated as spot urine calcium-creatinine ratio | Posted | Mean | Standard Deviation | mg per g of creatinine | 16 weeks |
|
|
|
| Secondary | Change in Serum Calcium Concentrations | Posted | Mean | Standard Deviation | mg/dL | 16 weeks |
|
|
|
| 1 |
| 499 |
| 2 |
| 499 |
| 55 |
| 499 |
| EG001 | Placebo | Placebo | 0 | 167 | 2 | 167 | 16 | 167 |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Death | General disorders | Systematic Assessment |
|
| Kidney stone | Renal and urinary disorders | Systematic Assessment |
|
| Gastrointestinal disorders | Gastrointestinal disorders | Systematic Assessment |
|
| General disorders and administration site conditions | General disorders | Systematic Assessment |
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| Immune system disorders | Immune system disorders | Systematic Assessment |
|
| Metabolism and nutrition disorders | Metabolism and nutrition disorders | Systematic Assessment |
|
| Musculoskeletal, connective tissue, and bone disorders | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Neoplasms benign, malignant, and unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Psychiatric disorders | Psychiatric disorders | Systematic Assessment |
|
| Renal and urinary tract disorders | Renal and urinary disorders | Systematic Assessment |
|
| Respiratory, thoracic, and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| General disorders | Systematic Assessment |
|
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| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |