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Vitamin D to Improve Outcomes by Leveraging Early Treatment: Long-term Brain Outcomes in Vitamin D Deficient Patients

NCT03733418 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 95

Last updated 2024-10-21

Study results available
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Summary

This ancillary study will determine if early administration of a single high-dose (540,000 IU) oral vitamin D3 (cholecalciferol) treatment improves 12-month global cognition and executive function as determined by comprehensive neuropsychological testing in 140 critically ill patients with Vitamin D deficiency at enrollment.

Conditions

Interventions

DRUG

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.

DRUG

Placebo

Placebo that matched the vitamin D3 color was provided.

Sponsors & Collaborators

  • Beth Israel Deaconess Medical Center

    collaborator OTHER

  • Brigham and Women's Hospital

    collaborator OTHER

  • University of Colorado, Denver

    collaborator OTHER

  • Montefiore Medical Center

    collaborator OTHER

  • Intermountain Medical Center

    collaborator OTHER

  • Oregon Health and Science University

    collaborator OTHER

  • Vanderbilt University Medical Center

    lead OTHER

Principal Investigators

  • Jin H. Han, MD · Vanderbilt University Medical Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-01
Primary Completion
2019-10-02
Completion
2020-02-21

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03733418 on ClinicalTrials.gov