Vitamin D to Improve Outcomes by Leveraging Early Treatment: Long-term Brain Outcomes in Vitamin D Deficient Patients
NCT ID: NCT03733418
Last Updated: 2024-10-21
Study Results
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View full resultsBasic Information
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COMPLETED
95 participants
OBSERVATIONAL
2018-11-01
2020-02-21
Brief Summary
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Detailed Description
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This ancillary study will provide additional funding to perform comprehensive neuropsychological (cognitive) evaluations, which were not part of the parent trial. These neuropsychological evaluations will be conducted 12 (+/- 4) months after randomization among a subset of 140 survivors enrolled in VIOLET. This ancillary study will conducted in 7 (out of 42) sites.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Intervention
Patients who received high dose D3 and completed the neuropsychological evaluations at 12 (+/-4) months after randomization.
540,000 IU vitamin D3
This intervention was administered as part of VIOLET parent study. A single dose of 540,000 IU vitamin D3 was administered within 2 hours of randomization time.
Placebo
Patients who received placebo and completed the neuropsychological evaluations at 12 (+/-4) months after randomization.
Placebo
Placebo that matched the vitamin D3 color was provided.
Interventions
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540,000 IU vitamin D3
This intervention was administered as part of VIOLET parent study. A single dose of 540,000 IU vitamin D3 was administered within 2 hours of randomization time.
Placebo
Placebo that matched the vitamin D3 color was provided.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Non-English speaking
18 Years
ALL
No
Sponsors
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Beth Israel Deaconess Medical Center
OTHER
Brigham and Women's Hospital
OTHER
University of Colorado, Denver
OTHER
Montefiore Medical Center
OTHER
Intermountain Medical Center
OTHER
Oregon Health and Science University
OTHER
Vanderbilt University Medical Center
OTHER
Responsible Party
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Jin H. Han
Associate Professor
Principal Investigators
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Jin H. Han, MD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center
Locations
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University of Colorado Hospital
Aurora, Colorado, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Montefiore Medical Center
New York, New York, United States
Oregon Health and Science University Hospital
Portland, Oregon, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Intermountain Medical Center
Murray, Utah, United States
Countries
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References
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Han JH, Ginde AA, Brown SM, Baughman A, Collar EM, Ely EW, Gong MN, Hope AA, Hou PC, Hough CL, Iwashyna TJ, Jackson JC, Khan A, Orun OM, Patel MB, Raman R, Rice TW, Ringwood N, Semler MW, Shapiro NI, Talmor DS, Self WH; Vitamin D to Improve Outcomes by Leveraging Early Treatment Network Investigators. Effect of Early High-Dose Vitamin D3 Repletion on Cognitive Outcomes in Critically Ill Adults. Chest. 2021 Sep;160(3):909-918. doi: 10.1016/j.chest.2021.03.046. Epub 2021 Apr 2.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Pubmed link to manuscript
Other Identifiers
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181553
Identifier Type: -
Identifier Source: org_study_id
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