Correction of vitamin D deficiency in critically ill patients - VITdAL@ICU study protocol of a double-blind, placebo-controlled randomized clinical trial.
BMC Endocr Disord. 2012 Nov 7;12(1):27
Amrein K, Schnedl C, Berghold A, Pieber TR, Dobnig H.
BACKGROUND: Vitamin D deficiency is associated with multiple adverse health outcomes including increased morbidity and mortality in the general population and in critically ill patients. However, no randomized controlled trial has evaluated so far whether treatment with sufficiently large doses of vitamin D can improve clinical outcome of patients in an intensive care setting.
The VITdAL@ICU trial is an investigator-initiated, non-commercial, double-blind, placebo-controlled randomized clinical trial. This study compares high-dose oral cholecalciferol (vitamin D3) versus placebo treatment in a mixed population of 480 critically ill patients with low 25-hydroxyvitamin-D levels at study enrollment (<= 20ng/ml). Following an initial loading dose of 540,000 IU of vitamin D3, patients receive 90,000 IU of vitamin D3 on a monthly basis for 5 months. The study is designed to compare clinical outcome in the two study arms with the primary endpoint being length of hospital stay. Secondary endpoints include among others length of ICU stay, the percentage of patients with 25(OH)D levels > 30 ng/ml at day 7, ICU and hospital mortality and duration of mechanical ventilation. We describe here the VITdAL@ICU study protocol for the primary report.
This trial is designed to evaluate whether high-dose vitamin D3 is able to improve morbidity and mortality in a mixed population of adult critically ill patients and correct vitamin D deficiency safely.Trial registration ClinicalTrials: NCT01130181
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540,000 IU loading dose is a somewhat typical total loading dose spread out over a month or so, but this apparently was given as a single liquid dose
While we see the ICU need for urgency, perhaps a test for rare vitamin D allergy should have been made first
Ongoing amount is 90,000 IU/month = 3,000 IU daily = not excessive, and far far better than 200 IU daily via IV in ICU
- 5 days longer in ICU if low on vitamin D - April 2012
- All items in category After Surgery or Trauma
- ICU time is 2X more likely to be longer than 2 days if vitamin D less than 20 ng – Mar 2011
- Health Care Providers save $ by providing vitamin D before and/or after surgery or trauma - reduces the time in bed, etc.
- Overview Loading of vitamin D
- 3X more likely to die within 3 months of being in ICU for 2 days if less than 20 ng vitamin D – Sept 2013
- 540000 IU before ICU raised vitamin D level average at least 25 ng – March 2011
Which is an early report of the same RCT - which has the following chartWill lots of vitamin D help in ICU – RCT protocol Nov 2012
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