title: 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: BACKGROUND
  Vitamin 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.
  
  
  METHODS
  This 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 ± 16 yrs) 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.
  
  
  RESULTS
  The 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.
  
  
  CONCLUSIONS
  This 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 NUMBER: 2009-012080-34 GERMAN CLINICAL TRIALS REGISTER (DRKS): DRKS00000750.
authors: Medical University of Graz, Department of Internal Medicine, Division of Endocrinology and Metabolism, Auenbruggerplatz 15, 8036 Graz, Austria.
authors: Karin
authors: K
authors: Amrein
authors: Harald
authors: H
authors: Sourij
authors: Gerit
authors: G
authors: Wagner
authors: Alexander
authors: A
authors: Holl
authors: Thomas R
authors: TR
authors: Pieber
authors: Karl Heinz
authors: KH
authors: Smolle
authors: Tatjana
authors: T
authors: Stojakovic
authors: Christian
authors: C
authors: Schnedl
authors: Harald
authors: H
authors: Dobnig
mesh_terms: D000284:Administration, Oral; D000368:Aged; D002762:Cholecalciferol / Q000009:adverse effects / Q000097:blood / Q000627:therapeutic use*; D003422:Critical Care / Q000379:methods*; D016638:Critical Illness; D019587:Dietary Supplements; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D013997:Time Factors; D016896:Treatment Outcome; D014808:Vitamin D Deficiency / Q000188:drug therapy*; D014815:Vitamins / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D014815:Vitamins; D002762:Cholecalciferol