Last updated on July 2018

Vitamin D to Improve Outcomes by Leveraging Early Treatment


Brief description of study

This study aims to evaluate the effect of early administration of high-dose vitamin D3 in reducing all-cause, all-location mortality in vitamin D deficient patients at high risk for ARDS. Patients will be screened for vitamin D deficiency (<20 ng/mL). Only patients screened as vitamin D deficient will be randomized. Half of the vitamin-D deficient patients will be given a high-dose of vitamin D3 and the other half will be given a placebo.

Detailed Study Description

Primary Objective:

To assess the efficacy and safety of early administration of vitamin D3 (cholecalciferol) in reducing mortality and morbidity for vitamin D deficient patients at high risk for ARDS and mortality.

Primary Hypothesis:

Early administration of vitamin D3 (cholecalciferol) will improve all-cause, all-location mortality to day 90 in vitamin D deficient patients at high risk for ARDS and mortality.

Patients will be recruited from the EDs, hospital wards, operating rooms, ICUs and other acute care areas of the PETAL Network Clinical Centers. Screening will include a test for Vitamin D (25OHD) levels using either the hospital's clinical laboratory or an FDA-approved point-of-care device (FastPack IP, Qualigen Inc). Patients screened as vitamin D deficient (<20 ng/mL) will be randomized. Half of the randomized patients will receive an early administration of high-dose vitamin D3 and the other half will receive a placebo (orally or via naso/orogastric tube).

Vitamin D has pleiotropic roles in regulating immune function and maintaining epithelial surface integrity. Strong preclinical data support the protective role of vitamin D in regulating pulmonary inflammation and disruption of the alveolar-capillary membrane that are fundamental to ARDS pathogenesis.

Clinical Study Identifier: NCT03096314

Contact Investigators or Research Sites near you

Start Over

Katie Oldmixon, RN

UCSF Fresno
Fresno, CA United States

Katie Oldmixon, RN

Ronald Reagan UCLA Medical Center
Los Angeles, CA United States

Katie Oldmixon, RN

UC Davis Medical Center
Sacramento, CA United States

Katie Oldmixon, RN

UCSF Medical Center
San Francisco, CA United States

Katie Oldmixon, RN

Stanford University
Stanford, CA United States

Katie Oldmixon, RN

Medical Center of Aurora
Aurora, CO United States

Katie Oldmixon, RN

University of Colorado Hospital
Aurora, CO United States

Katie Oldmixon, RN

St. Joseph Hospital
Del Norte, CO United States

Katie Oldmixon, RN

Denver Health Medical Center
Denver, CO United States

Katie Oldmixon, RN

Swedish Medical Center
Englewood, CO United States

Katie Oldmixon, RN

IU Health Methodist Hospital
Indianapolis, IN United States

Katie Oldmixon, RN

University of Kentucky
Lexington, KY United States

Katie Oldmixon, RN

University Medical Center
New Orleans, LA United States

Katie Oldmixon, RN

Maine Medical Center
Portland, ME United States

Katie Oldmixon, RN

Tufts Medical Center
Boston, MA United States

Katie Oldmixon, RN

Brigham and Women's Hospital
Boston, MA United States

Katie Oldmixon, RN

Massachusetts General Hospital
Boston, MA United States

Katie Oldmixon, RN

Beth Israel Deaconess Medical Center
Boston, MA United States

Katie Oldmixon, RN

Baystate Medical Center
Springfield, MA United States

Katie Oldmixon, RN

St. Vincent's Hospital
Worcester, MA United States

Katie Oldmixon, RN

University of Michigan Medical Center
Ann Arbor, MI United States

Katie Oldmixon, RN

Henry Ford Medical Center
Detroit, MI United States

Katie Oldmixon, RN

University of Mississippi Medical Center
Jackson, MS United States

Katie Oldmixon, RN

Mt. Sinai Hospital
New York, NY United States

Katie Oldmixon, RN

Montefiore Medical Center
The Bronx, NY United States

Katie Oldmixon, RN

Wake Forest Baptist Medical Center
Winston-Salem, NC United States

Katie Oldmixon, RN

Summa Akron City Hospital
Akron, OH United States

Katie Oldmixon, RN

University of Cincinnati Medical Center
Cincinnati, OH United States

Katie Oldmixon, RN

Cleveland Clinic Foundation
Cleveland, OH United States

Katie Oldmixon, RN

OSU Hospital East Campus
Columbus, OH United States

Katie Oldmixon, RN

Ohio State University Wexner Medical Center
Columbus, OH United States

Katie Oldmixon, RN

Providence Portland Medical Center
Portland, OR United States

Katie Oldmixon, RN

Oregon Health and Science University
Portland, OR United States

Katie Oldmixon, RN

Penn State Hershey Medical Center
Hershey, PA United States

Katie Oldmixon, RN

UPMC Presbyterian/Mercy/Shadyside
Pittsburgh, PA United States

Katie Oldmixon, RN

Vanderbilt University Medical Center
Nashville, TN United States

Katie Oldmixon, RN

Intermountain Medical Center
Murray, UT United States

Katie Oldmixon, RN

McKay-Dee Hospital
Ogden, UT United States

Katie Oldmixon, RN

Utah Valley Regional Medical Center
Provo, UT United States

Katie Oldmixon, RN

University of Utah Hospital
Salt Lake City, UT United States

Katie Oldmixon, RN

LDS Hospital
Salt Lake City, UT United States

Katie Oldmixon, RN

University of Virginia Health System
Charlottesville, VA United States

Katie Oldmixon, RN

VCU Medical Center
Richmond, VA United States

Katie Oldmixon, RN

Harborview Medical Center
Seattle, WA United States

Katie Oldmixon, RN

University of Washington Medical Center
Seattle, WA United States

Katie Oldmixon, RN

Swedish Hospital Cherry Hill
Seattle, WA United States

Katie Oldmixon, RN

Swedish Hospital First Hill
Seattle, WA United States