Eva Wolf1,2, Markus Utech1, Peter Stehle2, Martin Büsing1, Hans-Peter Helfrich3, Birgit Stoffel-Wagner4, Sarah Egert2, Birgit Alteheld2, Raute Riege1, Annette Knapp1, Sabine Ellinger5,6. 1. Department of General and Visceral Surgery, Klinikum Vest, Dorstener Str. 151, 45657, Recklinghausen, Germany. 2. Department of Nutrition and Food Sciences, Nutritional Physiology, University of Bonn, Endenicher Allee 11-13, 53115, Bonn, Germany. 3. Institute for Numerical Simulation, University of Bonn, Endenicher Allee 60, 53115, Bonn, Germany. 4. Department of Clinical Chemistry and Clinical Pharmacology, University Hospital Bonn, Sigmund-Freud-Str. 25, 53127, Bonn, Germany. 5. Department of Nutrition and Food Sciences, Nutritional Physiology, University of Bonn, Endenicher Allee 11-13, 53115, Bonn, Germany. Sabine.Ellinger@hs-niederrhein.de. 6. Faculty of Food, Nutrition and Hospitality Sciences, Hochschule Niederrhein, University of Applied Sciences, Rheydter Str. 277, 41065, Mönchengladbach, Germany. Sabine.Ellinger@hs-niederrhein.de.
Abstract
BACKGROUND: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. METHODS:Morbidly obese patients (n = 94, BMI 51.8 ± 11.5 kg/m(2)) receivedorally 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. RESULTS: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. CONCLUSION: 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. CLINICAL TRIAL REGISTRATION: This trial was registered retrospectively on November 14, 2014, at the German Clinical Trials Register as DRKS00007143.
RCT Entities:
BACKGROUND:Osteomalacia and cardiometabolic disorders are favored in morbidly obesepatients 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. METHODS: Morbidly obesepatients (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. RESULTS: 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. CONCLUSION: 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. CLINICAL TRIAL REGISTRATION: This trial was registered retrospectively on November 14, 2014, at the German Clinical Trials Register as DRKS00007143.
Entities:
Keywords:
25-hydroxycholecalciferol; Bariatric surgery; Obesity; Sleeve gastrectomy; Supplementation; Vitamin D
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