Short-term effects of high-dose oral vitamin D3 in critically ill vitamin D deficient patients: a randomized, double-blind, placebo-controlled pilot study

Abstract

IntroductionVitamin D deficiency is encountered frequently in critically ill patients and might be harmful. Current nutrition guidelines recommend very low vitamin D doses. The objective of this trial was to evaluate the safety and efficacy of a single oral high-dose vitamin D3 supplementation in an intensive care setting over a one-week observation period.MethodsThis was a randomized, double-blind, placebo-controlled pilot study in a medical ICU at a tertiary care university center in Graz, Austria. Twenty-five patients (mean age 62 ± 16yrs) with vitamin D deficiency [25-hydroxyvitamin D (25(OH)D) ≤20 ng/ml] and an expected stay in the ICU >48 hours were included and randomly received either 540,000 IU (corresponding to 13.5 mg) of cholecalciferol (VITD) dissolved in 45 ml herbal oil or matched placebo (PBO) orally or via feeding tube.ResultsThe mean serum 25(OH)D increase in the intervention group was 25 ng/ml (range 1-47 ng/ml). The highest 25(OH)D level reached was 64 ng/ml, while two patients showed a small (7 ng/ml) or no response (1 ng/ml). Hypercalcemia or hypercalciuria did not occur in any patient. From day 0 to day 7, total serum calcium levels increased by 0.10 (PBO) and 0.15 mmol/L (VITD; P < 0.05 for both), while ionized calcium levels increased by 0.11 (PBO) and 0.05 mmol/L (VITD; P < 0.05 for both). Parathyroid hormone levels decreased by 19 and 28 pg/ml (PBO and VITD, ns) over the seven days, while 1,25(OH)D showed a transient significant increase in the VITD group only.ConclusionsThis pilot study shows that a single oral ultra-high dose of cholecalciferol corrects vitamin D deficiency within 2 days in most patients without causing adverse effects like hypercalcemia or hypercalciuria. Further research is needed to confirm our results and establish whether vitamin D supplementation can affect the clinical outcome of vitamin D deficient critically ill patients.EudraCT Number2009-012080-34German Clinical Trials Register (DRKS)DRKS00000750

Preliminary Report: Vitamin D Deficiency in Advanced Cancer Patients with Symptoms of Fatigue or Anorexia

“…One study reported that higher physiological testosterone levels in older men and women may protect against falls, and that the benefit may be additive in those taking vitamin D supplementation [35]. In critically ill patients, a single oral ultrahigh dose of 540,000 IU cholecalciferol corrected vitamin D deficiency within 2 days without causing hypercalcemia [36]. Because vitamin D and testosterone replacement are relatively inexpensive and could improve symptoms, function, and quality of life, prospective intervention studies in patients with cancer are warranted.…”

Serum Vitamin D Level at ICU Admission and Mortality

“…However, we knew that all patients with low vitamin D level had received vitamin D as a single loading dose of 600,000 IU in this study. It has been demonstrated that vitamin D deficiency can be corrected with the same dose of enteral vitamin D replacement in critically ill patients (25,26). In our study, patients with vitamin D level <25 ng mL -1 at ICU admission had a median vitamin D level after vitamin D replacement of 31.6 ng mL -1 .…”

Hypocalcemia in the Critically Ill: A Mini-Review

“…Probably this was due to a substrate boost for local tissue mitochondrial 1-alpha-hydroxylase activity. There were large individual differences in 25(OH)D3 levels probably due to large variations in gastrointestinal absorption [51]. Intravenous formulations could overcome this problem but i.v administration of calcitriol had no impact on 25(OH)D3 and 1.25 di-(OH)D3 levels in septic patients as shown in the Mata-Granados study [28].…”