Study of early treatment, high dose Vitamin D impact on improving outcomes of ICU patients

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"Does Vitamin D improve a patient’s chances of living through a severe illness?"
Age:
18 to 100 years old
Gender:
Any
Healthy Volunteers:
No
Keywords:
Vitamin D deficiency, critical illness, acute respiratory distress syndrome
Type:
Drug study, Phase 3
Investigator:
Description
This study will look at 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 Acute Respiratory Distress Syndrome (ARDS). Patients will be screened for vitamin D deficiency . Only patients screened as vitamin D deficient will be included. 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.
This study requires
Review of medical record
Blood test
Vitamin D3/placebo administration
Three month follow- up phone call
Who can participate?
Inclusion Criteria:

1. Age ≥ 18 years

2. Intention to admit to ICU from emergency department, hospital ward, operating room, or outside facility

3. One or more of the following acute risk factors for ARDS and mortality contributing directly to the need for ICU admission:

Pulmonary

1. Pneumonia

2. Aspiration

3. Smoke Inhalation

4. Lung contusion

5. Mechanical ventilation for acute hypoxemic or hypercarbic respiratory failure Extra-Pulmonary

6. Shock

7. Sepsis

8. Pancreatitis

4. Vitamin D deficiency (screening 25OHD level <20 ng/mL)


Exclusion Criteria:

1. Inability to obtain informed consent

2. Unable to randomize within 12 hours of ICU admission decision

3. Unable to take study medication by mouth or enteral tube

4. Baseline serum calcium >10.2 mg/dL (2.54 mmol/L) or ionized calcium >5.2 mg/dL (1.30 mmol/L)

5. Known kidney stone in past year or history of multiple (>1) prior kidney stone episodes

6. Decision to withhold or withdraw life-sustaining treatment (patients are still eligible if they are committed to full support except cardiopulmonary resuscitation if a cardiac arrest occurs)

7. Expect <48 hour survival

8. If no other risk factors present, a) mechanical ventilation primarily for airway protection, pain/agitation control, or procedure; or b) elective surgical patients with routine postoperative mechanical ventilation; or c) anticipated mechanical ventilation duration <24 hours; or d) chronic/home mechanical ventilation for chronic lung or neuromuscular disease (non-invasive ventilation used solely for sleep-disordered breathing is not an exclusion).

9. Prisoner

10. Pregnancy
Resources
Schedule
Study duration and period
Three months
Recruitment period
From June 16, 2017
Location
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Contact
Skyler Pearson
Research Topic
Conditions:
  • Acute Respiratory Distress Syndrome
  • Vitamin D Deficiency
  • Critical Illness

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