VITdAL-ICU: What does it mean to you
The VITdAL@ICU trial is an investigator-initiated, non-commercial, prospective, randomised, controlled trial comparing high-dose oral cholecalciferol (vitamin D3) versus placebo treatment in a mixed population of 480 critically ill patients with low 25 OHD levels (<= 20 ng/mL) at the time of admission to the ICU study enrolment.
Patients received an initial bolus dose of 540,000 IU of vitamin D3 and 90,000 IU of vitamin D3 on a monthly basis for 5 months resulting in a total treatment observation period of 6 months.
The primary outcome was hospital length of stay.
Secondary outcomes included hospital mortality, ICU mortality and 6 month mortality.
Listen to the podcast to hear Karin’s take on the results, the implications, as well as how she pulled it off with two young kids.
Karin Amrein, MD, MSc is Assistant Professor and Consultant in Internal Medicine/Endocrinology and has a subspecialty degree in intensive care medicine. She trained at the Medical University of Graz, Austria including one Erasmus semester in Cagliari, Italy, graduating in 2001 as the youngest MD in Austria (aged 21). Following this Karin started training in general internal medicine in Switzerland (Sursee, Bern).
In 2006, she returned to Austria, made a detour to transfusion medicine (Medical University of Graz) and developed an interest in clinical research, studying the effects of apheresis on bone health of blood donors. In 2008, she moved to the Division of Endocrinology and was involved in several ICU trials on glycemic control. At this time Karin realised the huge potential that exists for critical care research, conducted the VITdAL@ICU pilot trial and developed the protocol for the larger study, starting in 2010.
Karin is the lead author of the VITdAL-ICU randomized clinical trial, the first large randomized controlled trial on vitamin D in critical care. It was recently presented at the Annual Congress of the European Society of Intensive Care Medicine, and published in JAMA in September 2014.
Her major research interests are vitamin D and glucose control in critical illness, bone metabolism in critical care and other settings, and donor health, specifically donation induced iron depletion (and its therapy) and the effects of apheresis on bone health.
In pre-defined subgroup analysis there was a suggestion of a hospital mortality benefit for patients with SEVERE Vit D deficiency who received Vit D rather than Placebo.
This was significant in the log rank test for 28-day, 6 month and hospital mortality (Table 2) and in the test for interaction for hospital mortality.
However, with this being a subgroup finding and a secondary endpoint, the study was not powered to look at this.
These findings are very promising, and at the very least, hypothesis generating.
If this had been a Vit D drug company sponsored trial, you can imagine the fanfare surrounding this result would be much louder!
Here is the Figure 2B Karin refers to in the podcast.
The brief Vit D inspired music clips in the Podcast are from the late Heavy D’s This is Your Night; the Jamaican-born American rapper is unlike the population of this study, which is remarkable in having a 100% caucasian population. Thanks to Chris B(@smaccteam) for suggesting this.
Karin and many others will be at Rob Mac Sweeney’s Crit Care Reviews Meeting in Belfast on 21st of Jan 2015.
Find out more!
