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The link between obesity and vitamin D in bariatric patients with omega-loop gastric bypass surgery - a vitamin D supplementation trial to compare the efficacy of postoperative cholecalciferol loading (LOAD): study protocol for a randomized controlled trial.
Trials 2015; 16:328T

Abstract

BACKGROUND

Beyond its classical role in calcium homoeostasis and bone metabolism, vitamin D deficiency has been found to be associated with several diseases, including diabetes, non-alcoholic fatty liver disease, and even obesity itself. Importantly, there are limited data on therapeutic strategies for vitamin D deficiency in bariatric patients, and the procedure-specific guidelines may not be sufficient. To improve long-term outcomes, nutritional screening and appropriate supplementation to prevent nutrient deficiencies are urgently needed. Therefore, the aim of this study is to examine effects and safety of a forced dosing regimen of vitamin D versus conventional dose supplementation on vitamin D levels and other parameters in bariatric patients.

METHODS/DESIGN

The study includes loading plus repeat dosing compared with repeated administration of vitamin D without a loading dose, according to guidelines, in a prospective, double-blind, randomized controlled trial. Up to a triple oral loading dose is given on day 1, then 2 and 4 weeks after surgery (100,000 IU dose each time), followed by an oral maintenance dose (3420 IU/day). The control group (n = 25) will receive placebo, followed by administration of a standard dose (3420 IU/day). We hypothesize that a significant increase in vitamin D levels will occur in patients in the treatment group (n = 25) by 24 weeks after surgery. Further measurements are aimed at evaluating changes in inflammation, bone turnover, insulin resistance, blood pressure, liver, mental health, and gut microbiota of patients undergoing omega-loop gastric bypass surgery. Furthermore, possible associations between concentrations of vitamin D, the involved enzymes, or vitamin D receptor in adipose and/or liver tissues will be determined.

DISCUSSION

To our knowledge, this trial is the first of its kind with this type of vitamin D supplementation in bariatric patients. Its major strength is the design and implementation of evaluation of influencing factors such as liver function, bone health, inflammation, insulin resistance, blood pressure, symptoms of depression, or microbiota. This alternative vitamin D dosing regimen has the potential to be a safe, fast, evidence-based treatment of vitamin D deficiency in bariatric patients. Owing to the increasing number of bariatric patients, it is also of interest to elucidate the link between obesity and vitamin D.

TRIAL REGISTRATION

ClinicalTrials.gov identifier: NCT02092376 . Registered on 17 March 2014.

Authors+Show Affiliations

Division of Endocrinology and Metabolism, Department of Internal Medicine III, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria. maria.luger@meduniwien.ac.at. Special Institute for Preventive Cardiology and Nutrition - SIPCAN, Guggenbichlerstraβe 8/15, 5026, Salzburg, Austria. maria.luger@meduniwien.ac.at.Division of Endocrinology and Metabolism, Department of Internal Medicine III, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria. renate.kruschitz@meduniwien.ac.at.Clinical Institute for Medical and Chemical Laboratory Diagnostics, Department of Laboratory Medicine, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria. rodrig.marculescu@meduniwien.ac.at.Clinical Institute for Medical and Chemical Laboratory Diagnostics, Department of Laboratory Medicine, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria. helmuth.haslacher@meduniwien.ac.at.Special Institute for Preventive Cardiology and Nutrition - SIPCAN, Guggenbichlerstraβe 8/15, 5026, Salzburg, Austria. office@sipcan.at.Department of Pathophysiology and Allergy Research, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria. enikoe.kallay@meduniwien.ac.at.Division of Gastroenterology and Hepatology, Department of Internal Medicine III, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria. christian.a.kienbacher@meduniwien.ac.at.Division of Endocrinology and Metabolism, Department of Internal Medicine III, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria. n0748048@students.meduniwien.ac.at.Division of Gastroenterology and Hepatology, Department of Internal Medicine III, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria. melanie.kral@akhwien.at.Division of General Surgery, Department of Surgery, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria. felix.langer@meduniwien.ac.at.Institute of Social Medicine, Centre for Public Health, Medical University of Vienna, Kinderspitalgasse 15/1, 1090, Vienna, Austria. eva.luger@meduniwien.ac.at.Division of General Surgery, Department of Surgery, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria. gerhard.prager@meduniwien.ac.at.Division of Gastroenterology and Hepatology, Department of Internal Medicine III, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria. michael.trauner@meduniwien.ac.at.Division of Gastroenterology and Hepatology, Department of Internal Medicine III, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria. stefan.traussnigg@meduniwien.ac.at.Department of Pathology, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria. tanja.wuerger@meduniwien.ac.at.Division of Endocrinology and Metabolism, Department of Internal Medicine III, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria. karin.schindler@meduniwien.ac.at.Division of Endocrinology and Metabolism, Department of Internal Medicine III, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria. bernhard.ludvik@meduniwien.ac.at.

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

26242295

Citation

Luger, Maria, et al. "The Link Between Obesity and Vitamin D in Bariatric Patients With Omega-loop Gastric Bypass Surgery - a Vitamin D Supplementation Trial to Compare the Efficacy of Postoperative Cholecalciferol Loading (LOAD): Study Protocol for a Randomized Controlled Trial." Trials, vol. 16, 2015, p. 328.
Luger M, Kruschitz R, Marculescu R, et al. The link between obesity and vitamin D in bariatric patients with omega-loop gastric bypass surgery - a vitamin D supplementation trial to compare the efficacy of postoperative cholecalciferol loading (LOAD): study protocol for a randomized controlled trial. Trials. 2015;16:328.
Luger, M., Kruschitz, R., Marculescu, R., Haslacher, H., Hoppichler, F., Kallay, E., ... Ludvik, B. (2015). The link between obesity and vitamin D in bariatric patients with omega-loop gastric bypass surgery - a vitamin D supplementation trial to compare the efficacy of postoperative cholecalciferol loading (LOAD): study protocol for a randomized controlled trial. Trials, 16, p. 328. doi:10.1186/s13063-015-0877-9.
Luger M, et al. The Link Between Obesity and Vitamin D in Bariatric Patients With Omega-loop Gastric Bypass Surgery - a Vitamin D Supplementation Trial to Compare the Efficacy of Postoperative Cholecalciferol Loading (LOAD): Study Protocol for a Randomized Controlled Trial. Trials. 2015 Aug 5;16:328. PubMed PMID: 26242295.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The link between obesity and vitamin D in bariatric patients with omega-loop gastric bypass surgery - a vitamin D supplementation trial to compare the efficacy of postoperative cholecalciferol loading (LOAD): study protocol for a randomized controlled trial. AU - Luger,Maria, AU - Kruschitz,Renate, AU - Marculescu,Rodrig, AU - Haslacher,Helmuth, AU - Hoppichler,Friedrich, AU - Kallay,Enikö, AU - Kienbacher,Christian, AU - Klammer,Carmen, AU - Kral,Melanie, AU - Langer,Felix, AU - Luger,Eva, AU - Prager,Gerhard, AU - Trauner,Michael, AU - Traussnigg,Stefan, AU - Würger,Tanja, AU - Schindler,Karin, AU - Ludvik,Bernhard, Y1 - 2015/08/05/ PY - 2014/12/01/received PY - 2015/07/17/accepted PY - 2015/8/6/entrez PY - 2015/8/6/pubmed PY - 2016/5/3/medline SP - 328 EP - 328 JF - Trials JO - Trials VL - 16 N2 - BACKGROUND: Beyond its classical role in calcium homoeostasis and bone metabolism, vitamin D deficiency has been found to be associated with several diseases, including diabetes, non-alcoholic fatty liver disease, and even obesity itself. Importantly, there are limited data on therapeutic strategies for vitamin D deficiency in bariatric patients, and the procedure-specific guidelines may not be sufficient. To improve long-term outcomes, nutritional screening and appropriate supplementation to prevent nutrient deficiencies are urgently needed. Therefore, the aim of this study is to examine effects and safety of a forced dosing regimen of vitamin D versus conventional dose supplementation on vitamin D levels and other parameters in bariatric patients. METHODS/DESIGN: The study includes loading plus repeat dosing compared with repeated administration of vitamin D without a loading dose, according to guidelines, in a prospective, double-blind, randomized controlled trial. Up to a triple oral loading dose is given on day 1, then 2 and 4 weeks after surgery (100,000 IU dose each time), followed by an oral maintenance dose (3420 IU/day). The control group (n = 25) will receive placebo, followed by administration of a standard dose (3420 IU/day). We hypothesize that a significant increase in vitamin D levels will occur in patients in the treatment group (n = 25) by 24 weeks after surgery. Further measurements are aimed at evaluating changes in inflammation, bone turnover, insulin resistance, blood pressure, liver, mental health, and gut microbiota of patients undergoing omega-loop gastric bypass surgery. Furthermore, possible associations between concentrations of vitamin D, the involved enzymes, or vitamin D receptor in adipose and/or liver tissues will be determined. DISCUSSION: To our knowledge, this trial is the first of its kind with this type of vitamin D supplementation in bariatric patients. Its major strength is the design and implementation of evaluation of influencing factors such as liver function, bone health, inflammation, insulin resistance, blood pressure, symptoms of depression, or microbiota. This alternative vitamin D dosing regimen has the potential to be a safe, fast, evidence-based treatment of vitamin D deficiency in bariatric patients. Owing to the increasing number of bariatric patients, it is also of interest to elucidate the link between obesity and vitamin D. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02092376 . Registered on 17 March 2014. SN - 1745-6215 UR - https://www.unboundmedicine.com/medline/citation/26242295/The_link_between_obesity_and_vitamin_D_in_bariatric_patients_with_omega_loop_gastric_bypass_surgery___a_vitamin_D_supplementation_trial_to_compare_the_efficacy_of_postoperative_cholecalciferol_loading__LOAD_:_study_protocol_for_a_randomized_controlled_trial_ L2 - https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-015-0877-9 DB - PRIME DP - Unbound Medicine ER -