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Short-term effects of high-dose oral vitamin D3 in critically ill vitamin D deficient patients: a randomized, double-blind, placebo-controlled pilot study.
Crit Care. 2011; 15(2):R104.CC

Abstract

INTRODUCTION

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+Show Affiliations

Medical University of Graz, Department of Internal Medicine, Division of Endocrinology and Metabolism, Auenbruggerplatz 15, 8036 Graz, Austria.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

21443793

Citation

Amrein, Karin, et al. "Short-term Effects of High-dose Oral Vitamin D3 in Critically Ill Vitamin D Deficient Patients: a Randomized, Double-blind, Placebo-controlled Pilot Study." Critical Care (London, England), vol. 15, no. 2, 2011, pp. R104.
Amrein K, Sourij H, Wagner G, et al. Short-term effects of high-dose oral vitamin D3 in critically ill vitamin D deficient patients: a randomized, double-blind, placebo-controlled pilot study. Crit Care. 2011;15(2):R104.
Amrein, K., Sourij, H., Wagner, G., Holl, A., Pieber, T. R., Smolle, K. H., Stojakovic, T., Schnedl, C., & Dobnig, H. (2011). Short-term effects of high-dose oral vitamin D3 in critically ill vitamin D deficient patients: a randomized, double-blind, placebo-controlled pilot study. Critical Care (London, England), 15(2), R104. https://doi.org/10.1186/cc10120
Amrein K, et al. Short-term Effects of High-dose Oral Vitamin D3 in Critically Ill Vitamin D Deficient Patients: a Randomized, Double-blind, Placebo-controlled Pilot Study. Crit Care. 2011;15(2):R104. PubMed PMID: 21443793.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Short-term effects of high-dose oral vitamin D3 in critically ill vitamin D deficient patients: a randomized, double-blind, placebo-controlled pilot study. AU - Amrein,Karin, AU - Sourij,Harald, AU - Wagner,Gerit, AU - Holl,Alexander, AU - Pieber,Thomas R, AU - Smolle,Karl Heinz, AU - Stojakovic,Tatjana, AU - Schnedl,Christian, AU - Dobnig,Harald, Y1 - 2011/03/28/ PY - 2010/11/03/received PY - 2011/01/21/revised PY - 2011/03/28/accepted PY - 2011/3/30/entrez PY - 2011/3/30/pubmed PY - 2011/12/13/medline SP - R104 EP - R104 JF - Critical care (London, England) JO - Crit Care VL - 15 IS - 2 N2 - INTRODUCTION: 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. SN - 1466-609X UR - https://www.unboundmedicine.com/medline/citation/21443793/Short_term_effects_of_high_dose_oral_vitamin_D3_in_critically_ill_vitamin_D_deficient_patients:_a_randomized_double_blind_placebo_controlled_pilot_study_ L2 - https://ccforum.biomedcentral.com/articles/10.1186/cc10120 DB - PRIME DP - Unbound Medicine ER -