title: Oral High-Dose Vitamin D Dissolved in Oil Raised Serum 25-Hydroxy-Vitamin D to Physiological Levels in Obese Patients After Sleeve Gastrectomy-A Double-Blind, Randomized, and Placebo-Controlled Trial.
abstract: Osteomalacia and cardiometabolic disorders are favored in morbidly obese patients due to an inadequate vitamin D (VD) status. Former trials supplementing orally VD (20-50 μg/day) in crystalline form after sleeve gastrectomy (SG) could not stabilize serum 25-hydroxycholecalciferol levels at predefined concentrations (≥50 nmol/l). We hypothesized that VD in an oily suspension would increase its bioavailability resulting in normal serum VD levels minimizing markers of cardiometabolic risk.
  
  
  
  Morbidly obese patients (n = 94, BMI 51.8 ± 11.5 kg/m(2)) received orally 80 μg/day VD3 dissolved in oil or placebo (pure oil) in a randomized, double-blind, parallel-group study for 12 weeks after SG. 25-hydroxycholecalciferol, parathyroid hormone, albumin, alkaline phosphatase, phosphate, magnesium, calcium, creatinine, C-reactive protein, lipids, glucose, and glycated hemoglobin were determined in serum/plasma before surgery and after 4 and 12 weeks of supplementation. Intake of energy, fat, and VD were monitored using a 3-day food record.
  
  
  
  Seventy-nine patients were included in statistical analysis. Preoperatively, 77.2 and 40.5 % presented 25-hydroxycholecalciferol levels <75 and <50 nmol/l, respectively. After 12 weeks of supplementation, significantly more patients in the VD group exhibited levels >50 nmol/l (92 %) and >75 nmol/l (68 %) compared to the placebo group (54 and 22 %, respectively). Parameters of mineral metabolism and cardiometabolic risk were not modulated by intervention.
  
  
  
  Supplementation of 80 μg/day VD3 by oil is an effective and safe measure to prevent VD deficiency and to treat a preexisting undersupply in patients after SG. Cardiometabolic risk factors were, however, not affected; probably, higher VD doses might be necessary.
  
  
  
  This trial was registered retrospectively on November 14, 2014, at the German Clinical Trials Register as DRKS00007143.
authors.affiliation: Department of General and Visceral Surgery, Klinikum Vest, Dorstener Str. 151, 45657, Recklinghausen, Germany.|Department of Nutrition and Food Sciences, Nutritional Physiology, University of Bonn, Endenicher Allee 11-13, 53115, Bonn, Germany.
authors.forename: Eva
authors.initials: E
authors.lastname: Wolf
authors.affiliation: Department of General and Visceral Surgery, Klinikum Vest, Dorstener Str. 151, 45657, Recklinghausen, Germany.
authors.forename: Markus
authors.initials: M
authors.lastname: Utech
authors.affiliation: Department of Nutrition and Food Sciences, Nutritional Physiology, University of Bonn, Endenicher Allee 11-13, 53115, Bonn, Germany.
authors.forename: Peter
authors.initials: P
authors.lastname: Stehle
authors.affiliation: Department of General and Visceral Surgery, Klinikum Vest, Dorstener Str. 151, 45657, Recklinghausen, Germany.
authors.forename: Martin
authors.initials: M
authors.lastname: Büsing
authors.affiliation: Institute for Numerical Simulation, University of Bonn, Endenicher Allee 60, 53115, Bonn, Germany.
authors.forename: Hans-Peter
authors.initials: HP
authors.lastname: Helfrich
authors.affiliation: Department of Clinical Chemistry and Clinical Pharmacology, University Hospital Bonn, Sigmund-Freud-Str. 25, 53127, Bonn, Germany.
authors.forename: Birgit
authors.initials: B
authors.lastname: Stoffel-Wagner
authors.affiliation: Department of Nutrition and Food Sciences, Nutritional Physiology, University of Bonn, Endenicher Allee 11-13, 53115, Bonn, Germany.
authors.forename: Sarah
authors.initials: S
authors.lastname: Egert
authors.affiliation: Department of Nutrition and Food Sciences, Nutritional Physiology, University of Bonn, Endenicher Allee 11-13, 53115, Bonn, Germany.
authors.forename: Birgit
authors.initials: B
authors.lastname: Alteheld
authors.affiliation: Department of General and Visceral Surgery, Klinikum Vest, Dorstener Str. 151, 45657, Recklinghausen, Germany.
authors.forename: Raute
authors.initials: R
authors.lastname: Riege
authors.affiliation: Department of General and Visceral Surgery, Klinikum Vest, Dorstener Str. 151, 45657, Recklinghausen, Germany.
authors.forename: Annette
authors.initials: A
authors.lastname: Knapp
authors.affiliation: Department of Nutrition and Food Sciences, Nutritional Physiology, University of Bonn, Endenicher Allee 11-13, 53115, Bonn, Germany. Sabine.Ellinger@hs-niederrhein.de.|Faculty of Food, Nutrition and Hospitality Sciences, Hochschule Niederrhein, University of Applied Sciences, Rheydter Str. 277, 41065, Mönchengladbach, Germany. Sabine.Ellinger@hs-niederrhein.de.
authors.forename: Sabine
authors.identifier: 0000-0002-9988-9406
authors.initials: S
authors.lastname: Ellinger
mesh_terms: D000284:Administration, Oral; D000328:Adult; D019587:Dietary Supplements; D004311:Double-Blind Method; D005260:Female; D005743:Gastrectomy; D006801:Humans; D008297:Male; D009767:Obesity, Morbid / Q000150:complications / Q000601:surgery*; D011184:Postoperative Period; D016896:Treatment Outcome; D014807:Vitamin D / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000097:blood / Q000627:therapeutic use*; D014808:Vitamin D Deficiency / Q000097:blood / Q000150:complications / Q000188:drug therapy*
chemical_list: D014807:Vitamin D; C104450:25-hydroxyvitamin D
keywords: 25-hydroxycholecalciferol; Bariatric surgery; Obesity; Sleeve gastrectomy; Supplementation; Vitamin D