Short-term effects of high-dose oral vitamin D3 in critically ill vitamin D deficient patients: a randomized, double-blind, placebo-controlled pilot study
Amrein K, Sourij H, Wagner G, Holl A, Pieber TR, Smolle KH, Stojakovic T, Schnedl C, Dobnig H
Critical care (London, England) · 126 citas
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación independiente
- Universidad u hospital
- Karl-Franzens-Universität Graz
- Universidad u hospital
- Medizinische Universität Graz
Según 2 financiadores declarados y la declaración de financiación del texto completo.
Publicación
- Publicado
- 2011-03-28 · Crit Care · vol. 15 · número 2 · pág. R104
- Editorial
- BioMed Central
- Citado
- 183 citas · más que el 98% de estudios similares · 8.6× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 30 trabajos
- Acceso
- Acceso abierto (revista) · CC-BY
- Áreas de investigación
- Vitamin D Research Studies · Clinical Nutrition and Gastroenterology · Parathyroid Disorders and Treatments
- Palabras clave
- vitamin D deficiency, vitamin D3, critically ill patients, intensive care unit, 25-hydroxyvitamin D, serum calcium, parathyroid hormone, 1,25-dihydroxyvitamin D, hypercalcemia, hypercalciuria, vitamin D repletion, enteral nutrition
- MeSH
- humans, vitamin d deficiency, critical illness, cholecalciferol, vitamins, treatment outcome, critical care, administration, oral, pilot projects, double-blind method, dose-response relationship, drug, time factors, dietary supplements, aged, middle aged, female, male
9 autores
- Karin Amrein🇦🇹Medical University of Graz
- Harald Sourij🇦🇹Medical University of Graz
- Gerit Wagner🇦🇹Medical University of Graz
- Alexander Höll🇦🇹Medical University of Graz
- Thomas Rudolf Pieber🇦🇹Medical University of Graz
- Karl Heinz Smolle🇦🇹Medical University of Graz
- Tatjana Stojaković🇦🇹Medical University of Graz
- Christian Schnedl🇦🇹Medical University of Graz
- Harald Dobnig🇦🇹 · autor de correspondenciaMedical University of Graz
Resumen
El texto original del estudio, en el idioma en que se publicó.
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.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial (CC BY).
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