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ICU survival increased with vitamin D single loading dose - JAMA Sept 2014

Effect of High-Dose Vitamin D3 on Hospital Length of Stay in Critically Ill Patients With Vitamin D Deficiency The VITdAL-ICU Randomized Clinical Trial

JAMA. Published online September 30, 2014. doi:10.1001/jama.2014.13204
Karin Amrein, MD, MSc1; Christian Schnedl, MD1; Alexander Holl, MD2; Regina Riedl, MSc3; Kenneth B. Christopher, MD4; Christoph Pachler, MD5; Tadeja Urbanic Purkart, MD6; Andreas Waltensdorfer, MD5; Andreas Münch, MD5; Helga Warnkross, MD1; Tatjana Stojakovic, MD7; Egbert Bisping, MD8; Wolfgang Toller, MD5; Karl-Heinz Smolle, MD9; Andrea Berghold, PhD3; Thomas R. Pieber, MD1; Harald Dobnig, MD1,10

VitaminDWiki Comment: 540,000 IU loading dose

Vitamin D helped those who had very low levels (< 12ng) when entering the ICU
(Note: = 42% of patients)
Image
Vitamin D would have helped even more patients if
Had limited the amount of Calcium taken (But this is extremely hard to do in a RCT)
Had provided Omega-3 to increase the benefit of vitamin D to the cells
   (The results of Omega-3 are not measures by a blood test, but Omega-3 increases Vit D to the cellsl)

“However, only half of patients treated with vitamin D3 achieved serum 25-hydroxyvitamin D levels higher than 30ng/mL.”
Would have had significantly more responses > 30ng if they had
Provided other forms of vitamin D - there are about 20 - such as injection
Provided co-factors to increase the response – such as Magnesium ~30% increased response
Had spread the loading dose over a week or so ~20% increased response
Had given the vitamin D after the largest meal of the day ~30% increased response


Items in both categories Trauma-Surgery and Loading Dose are listed here:

Objective To investigate whether a vitamin D3 treatment regimen intended to restore and maintain normal vitamin D status over 6 months is of health benefit for patients in ICUs.

Design, Setting, and Participants A randomized double-blind, placebo-controlled, single-center trial, conducted from May 2010 through September 2012 at 5 ICUs that included a medical and surgical population of 492 critically ill adult white patients with vitamin D deficiency (≤20 ng/mL) assigned to receive either vitamin D3 (n = 249) or a placebo (n = 243).

Interventions Vitamin D3 or placebo was given orally or via nasogastric tube once at a dose of 540 000 IU followed by monthly maintenance doses of 90 000 IU for 5 months.

Main Outcomes and Measures The primary outcome was hospital length of stay. Secondary outcomes included, among others, length of ICU stay, the percentage of patients with 25-hydroxyvitamin D levels higher than 30 ng/mL at day 7, hospital mortality, and 6-month mortality. A predefined severe vitamin D deficiency (≤12 ng/mL) subgroup analysis was specified before data unblinding and analysis.

Results A total of 475 patients were included in the final analysis (237 in the vitamin D3 group and 238 in the placebo group). The median (IQR) length of hospital stay was not significantly different between groups (20.1 days [IQR, 11.1-33.3] for vitamin D3 vs 19.3 days [IQR, 11.1-34.9] for placebo; P = .98). Hospital mortality and 6-month mortality were also not significantly different (hospital mortality: 28.3% [95% CI, 22.6%-34.5%] for vitamin D3 vs 35.3% [95% CI, 29.2%-41.7%] for placebo; hazard ratio [HR], 0.81 [95% CI, 0.58-1.11]; P = .18; 6-month mortality: 35.0% [95% CI, 29.0%-41.5%] for vitamin D3 vs 42.9% [95% CI, 36.5%-49.4%] for placebo; HR, 0.78 [95% CI, 0.58-1.04]; P = .09). For the severe vitamin D deficiency subgroup analysis (n = 200), length of hospital stay was not significantly different between the 2 study groups: 20.1 days (IQR, 12.9-39.1) for vitamin D3 vs 19.0 days (IQR, 11.6-33.8) for placebo. Hospital mortality was significantly lower with 28 deaths among 98 patients (28.6% [95% CI, 19.9%-38.6%]) for vitamin D3 compared with 47 deaths among 102 patients (46.1% [95% CI, 36.2%-56.2%]) for placebo (HR, 0.56 [95% CI, 0.35-0.90], P for interaction = .04), but not 6-month mortality (34.7% [95% CI, 25.4%-45.0%] for vitamin D3 vs 50.0% [95% CI, 39.9%-60.1%] for placebo; HR, 0.60 [95% CI, 0.39-0.93], P for interaction = .12).

Conclusions and Relevance Among critically ill patients with vitamin D deficiency, administration of high-dose vitamin D3 compared with placebo did not reduce hospital length of stay, hospital mortality, or 6-month mortality. Lower hospital mortality was observed in the severe vitamin D deficiency subgroup, but this finding should be considered hypothesis generating and requires further study.

Trial Registration clinicaltrials.gov Identifier: NCT01130181

Stayed almost 2X longer in hospital than in ICU

(no indication of how much of hospital time before vs after ICU)
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If moderate vitamin D (12-20 ng) - only some improvement in survival

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See also VitaminDWiki

http://vitamindwiki.com/tiki-index.php?page_id=5466

 Download the PDF from VitaminDWiki.

Why did JAMA put out such negative PR for such a very positive study?

Press Release by JAMA "High-dose vitamin D for ICU patients who are vitamin D deficient does not improve outcomes"

Administration of high-dose vitamin D3 compared with placebo did not reduce hospital length of stay, intensive care unit (ICU) length of stay, hospital mortality, or the risk of death at 6 months among patients with vitamin D deficiency who were critically ill, according to a study published in JAMA. The study is being posted early online to coincide with its presentation at the European Society of Intensive Care Medicine annual congress.

A high prevalence of low vitamin D levels has been confirmed in patients who are critically ill. Many studies suggest that a low vitamin D status is a significant factor associated with disease severity, mortality, or a shorter survival time in the ICU. However, it is unknown whether a low vitamin D status is an independent contributor to the risk of illness or death for these patients, according to background information in the article.

Karin Amrein, M.D., M.Sc., of the Medical University of Graz, Austria, and colleagues randomly assigned 492 adult ICU patients with vitamin D deficiency to receive either high-dose vitamin D3 (n = 249) or a placebo (n = 243).

For the primary study outcome, length of hospital stay, the vitamin D3 group was not significantly different from the placebo group: 20.1 days vs 19.3 days. There was also no significant difference for length of ICU stay: 9.6 days for the vitamin D3 group vs 10.7 days for the placebo group.

Among the patients in the vitamin D3 group, 28.3 percent died in the hospital compared with 35.3 percent in the placebo group.
After 6 months, 35.0 percent of the patients had died in the vitamin D3 group and 42.9 percent in the placebo group.

Lower hospital mortality was observed in a subgroup of patients with severe vitamin D deficiency, but this finding should be considered hypothesis generating and requires further study, the authors write.

"Among patients with vitamin D deficiency who are critically ill, administration of high-dose vitamin D3 compared with placebo did not improve hospital length of stay, hospital mortality, or 6-month mortality."

That PR resulted in headlines such as

High Dose of Vitamin D among ICU Patients With the Deficiency Does Not Enhance Outcome
Vitamin D supplementation in the ICU does not improve outcomes [VITdAL-ICU trial]
Treating Vitamin D Deficient ICU Patients with Supplements was not Beneficial
Vitamin D Deficient ICU Patients Do Not Benefit From High-Dose Supplementation; No Reduction In Hospital Stay Length, Mortality
Vitamin D Blog: No Help in the ICU

Review of this study

Pediatric Critical Care Medical Website April 2015

ICU survival increased with vitamin D single loading dose - JAMA Sept 2014        

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Attached files

ID Name Comment Uploaded Size Downloads
4439 Total length of stay.jpg admin 01 Oct, 2014 14:46 16.95 Kb 1061
4438 ICU survive if 12 -20 ng initially.jpg admin 01 Oct, 2014 14:46 28.24 Kb 1074
4437 ICU survive if less than 12ng initially.jpg admin 01 Oct, 2014 14:46 29.13 Kb 3747
4436 High dose ICU.pdf PDF 2014 admin 01 Oct, 2014 14:16 325.19 Kb 785
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