Vitamin D3 Loading Is Superior to Conventional Supplementation After Weight Loss Surgery in Vitamin D-Deficient Morbidly Obese Patients: a Double-Blind Randomized Placebo-Controlled Trial

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Abstract

Background

Bariatric patients often suffer from vitamin D deficiency (VDD), and both, morbid obesity and VDD, are related to non-alcoholic fatty liver disease. However, limited data are available regarding best strategies for treating VDD, particularly, in bariatric patients undergoing omega-loop gastric bypass (OLGB). Therefore, we examined the efficacy and safety of a forced vitamin D dosing regimen and intervention effects in liver fibrotic patients.

Methods

In this double-blind, randomized, placebo-controlled trial, 50 vitamin D-deficient patients undergoing OLGB were randomly assigned to receive, in the first month postoperatively, oral vitamin D ₃ (≤3 doses of 100,000 IU; intervention group) or placebo as loading dose (control group) with subsequent maintenance dose (3420 IU/day) in both groups until 6-month visit.

Results

Compared with control group, higher increase of 25(OH)D (67.9 (21.1) vs. 55.7 nmol/L (21.1); p = 0.049) with lower prevalence of secondary hyperparathyroidism (10 vs. 24 %; p = 0.045) was observed in intervention group. No (serious) adverse events related to study medication were found. The loading dose regimen was more effective in increasing 25(OH)D in patients with significant liver fibrosis while this was not the case for conventional supplementation (placebo with maintenance dose) (71.5 (20.5) vs. 22.5 nmol/L (13.8); p = 0.022; n = 14).

Conclusions

Our findings indicate that a high vitamin D ₃ loading dose, in the first month postoperatively, with subsequent maintenance dose is effective and safe in achieving higher vitamin D concentrations in OLGB patients. Unexpectedly, it is more effective in patients with significant liver fibrosis which is of potentially high clinical relevance and requires further investigation.

Electronic supplementary material

The online version of this article (doi:10.1007/s11695-016-2437-0) contains supplementary material, which is available to authorized users.

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Most cited references 36

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Statistical Power Analysis for the Behavioral Sciences

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Statistical Power Analysis is a nontechnical guide to power analysis in research planning that provides users of applied statistics with the tools they need for more effective analysis. The Second Edition includes: * a chapter covering power analysis in set correlation and multivariate methods; * a chapter considering effect size, psychometric reliability, and the efficacy of "qualifying" dependent variables and; * expanded power and sample size tables for multiple regression/correlation.

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From vitamin D to hormone D: fundamentals of the vitamin D endocrine system essential for good health.

Anthony W Norman (2008)

New knowledge of the biological and clinical importance of the steroid hormone 1alpha,25-dihydroxyvitamin D(3) [1alpha,25(OH)(2)D(3)] and its receptor, the vitamin D receptor (VDR), has resulted in significant contributions to good bone health. However, worldwide reports have highlighted a variety of vitamin D insufficiency and deficiency diseases. Despite many publications and scientific meetings reporting advances in vitamin D science, a disturbing realization is growing that the newer scientific and clinical knowledge is not being translated into better human health. Over the past several decades, the biological sphere of influence of vitamin D(3), as defined by the tissue distribution of the VDR, has broadened at least 9-fold from the target organs required for calcium homeostasis (intestine, bone, kidney, and parathyroid). Now, research has shown that the pluripotent steroid hormone 1alpha,25(OH)(2)D(3) initiates the physiologic responses of >/=36 cell types that possess the VDR. In addition to the kidney's endocrine production of circulating 1alpha,25(OH)(2)D(3,) researchers have found a paracrine production of this steroid hormone in >/=10 extrarenal organs. This article identifies the fundamentals of the vitamin D endocrine system, including its potential for contributions to good health in 5 physiologic arenas in which investigators have clearly documented new biological actions of 1alpha,25(OH)(2)D(3) through the VDR. As a consequence, the nutritional guidelines for vitamin D(3) intake (defined by serum hydroxyvitamin D(3) concentrations) should be reevaluated, taking into account the contributions to good health that all 36 VDR target organs can provide.

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Strong association between non alcoholic fatty liver disease (NAFLD) and low 25(OH) vitamin D levels in an adult population with normal serum liver enzymes

Ilaria Barchetta, Francesco Angelico, Maria Del Ben … (2011)

Background Hypovitaminosis D has been recently recognized as a worldwide epidemic. Since vitamin D exerts significant metabolic activities, comprising free fatty acids (FFA) flux regulation from the periphery to the liver, its deficiency may promote fat deposition into the hepatocytes. Aim of our study was to test the hypothesis of a direct association between hypovitaminosis D and the presence of NAFLD in subjects with various degree of insulin-resistance and related metabolic disorders. Methods We studied 262 consecutive subjects referred to the Diabetes and Metabolic Diseases clinics for metabolic evaluation. NAFLD (non-alcoholic fatty liver disease) was diagnosed by upper abdomen ultrasonography, metabolic syndrome was identified according to the Third Report of National Cholesterol Education Program/Adult Treatment Panel (NCEP/ATPIII) modified criteria. Insulin-resistance was evaluated by means of HOMA-IR. Fatty-Liver-Index, a recently identified correlate of NAFLD, was also estimated. Serum 25(OH)vitamin D was measured by colorimetric method. Results Patients with NAFLD (n = 162,61.8%) had reduced serum 25(OH) vitamin D levels compared to subjects without NAFLD (14.8 ± 9.2 vs 20.5 ± 9.7 ng/ml, p < 0.001, OR 0.95, IC 95% 0.92-0.98). The relationship between NAFLD and reduced 25(OH)vitamin D levels was independent from age, sex, triglycerides, high density lipoproteins (HDL) and glycaemia (p < 0.005) and Fatty Liver Index inversely correlated with low 25(OH) vitamin D regardless sex, age and HOMA-IR (p < 0.007). Conclusions Low 25(OH)vitamin D levels are associated with the presence of NAFLD independently from metabolic syndrome, diabetes and insulin-resistance profile.

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Author and article information

Contributors

Maria Luger: maria.luger@medunwien.ac.at

Renate Kruschitz:

ORCID: http://orcid.org/0000-0001-6722-9780

+43 1 40160 34892 , renate.kruschitz@meduniwien.ac.at

Christian Kienbacher: christian.a.kienbacher@meduniwien.ac.at

Stefan Traussnigg: stefan.traussnigg@meduniwien.ac.at

Felix B. Langer: felix.langer@meduniwien.ac.at

Gerhard Prager: gerhard.prager@meduniwien.ac.at

Karin Schindler: karin.schindler@meduniwien.ac.at

Enikö Kallay: enikoe.kallay@meduniwien.ac.at

Friedrich Hoppichler: office@sipcan.at

Michael Trauner: michael.trauner@meduniwien.ac.at

Michael Krebs: michael.krebs@meduniwien.ac.at

Rodrig Marculescu: rodrig.marculescu@meduniwien.ac.at

Bernhard Ludvik: bernhard.ludvik@wienkav.at

Journal

Journal ID (nlm-ta): Obes Surg

Journal ID (iso-abbrev): Obes Surg

Title: Obesity Surgery

Publisher: Springer US (New York )

ISSN (Print): 0960-8923

ISSN (Electronic): 1708-0428

Publication date (Electronic): 12 November 2016

Publication date PMC-release: 12 November 2016

Publication date (Print): 2017

Volume: 27

Issue: 5

Pages: 1196-1207

Affiliations

[1 ]ISNI 0000 0000 9259 8492, GRID grid.22937.3d, Division of Endocrinology and Metabolism, Department of Internal Medicine III, , Medical University of Vienna, ; Vienna, Austria

[2 ]Special Institute for Preventive Cardiology and Nutrition-SIPCAN Save Your Life, Salzburg, Austria

[3 ]ISNI 0000 0000 9259 8492, GRID grid.22937.3d, Institute of Social Medicine, Centre for Public Health, , Medical University of Vienna, ; Vienna, Austria

[4 ]ISNI 0000 0004 0522 8258, GRID grid.413303.6, Department of Medicine 1 and Karl Landsteiner Institute for Obesity and Metabolic Diseases, , Rudolfstiftung Hospital, ; Juchgasse 25, 1030 Vienna, Austria

[5 ]ISNI 0000 0000 9259 8492, GRID grid.22937.3d, Division of Gastroenterology and Hepatology, Department of Internal Medicine III, , Medical University of Vienna, ; Vienna, Austria

[6 ]ISNI 0000 0000 9259 8492, GRID grid.22937.3d, Division of General Surgery, Department of Surgery, , Medical University of Vienna, ; Vienna, Austria

[7 ]ISNI 0000 0000 9259 8492, GRID grid.22937.3d, Department of Pathophysiology and Allergy Research, , Medical University of Vienna, ; Vienna, Austria

[8 ]Division of Internal Medicine, Krankenhaus der Barmherzigen Brüder Salzburg, Salzburg, Austria

[9 ]ISNI 0000 0000 9259 8492, GRID grid.22937.3d, Clinical Institute for Medical and Chemical Laboratory Diagnostics, Department of Laboratory Medicine, , Medical University of Vienna, ; Vienna, Austria

Author information

Renate Kruschitz http://orcid.org/0000-0001-6722-9780

Article

Publisher ID: 2437

DOI: 10.1007/s11695-016-2437-0

PMC ID: 5403855

PubMed ID: 27837387

SO-VID: 8845a1f3-b326-4cab-822e-a90d1661046b

License:

Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.

History

Funding

Funded by: Austrian Biobanking and BioMolecular resources Research Infrastructure

Funded by: Austrian Federal Ministry of Science, Research and Economy

Award ID: BMWFW GZ 10.470/0016-II/3/2013

Funded by: non-profit organization “Special Institute for Preventive Cardiology And Nutrition – SIPCAN save your life” (Salzburg)

Funded by: Fesenius Kabi

Custom metadata

ScienceOpen disciplines: Surgery

Keywords: vitamin d,vitamin d supplementation,obesity,gastric bypass,omega-loop gastric bypass,weight loss,secondary hyperparathyroidism,liver fibrosis

Data availability:

ScienceOpen disciplines: Surgery

Keywords: vitamin d, vitamin d supplementation, obesity, gastric bypass, omega-loop gastric bypass, weight loss, secondary hyperparathyroidism, liver fibrosis