Clinical trial NCT02092376: The Link Between Obesity And Vitamin D in Bariatric Patients With Omega-loop Bypass Surgery
Official title: The Link Between Obesity And Vitamin D in Bariatric Patients With Omega-loop Bypass Surgery: a Randomized Controlled, Double-blinded Clinical Supplementation Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bariatric Surgery Candidate
Keywords: Bariatric surgery
vitamin D
supplementation
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2014-03-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to increase vitamin D concentrations or to keep it on high level, respectively, by supplementing with vitamin D3 in a different dose regime, and to improve the overall health status in bariatric patients. In this project, the vitamin D status, the parameters of inflammation, bone turnover, insulin resistance, liver and depression score of bariatric patients are expected to improve, due to supplementation of a loading dose compared to the standard therapy.


Eligibility criteria: Inclusion Criteria:

* Planned omega loop bypass surgery
* 25-hydroxy vitamin D \< 75 nmol/l
* BMI \>40 or ≥35 kg/m2 with co-morbidities e.g. diabetes mellitus, hypertension
* Body weight \<140 kg (due to limitation of DEXA measurement)
* Capability to consent

Exclusion Criteria:

* Another planned form of bariatric surgery
* Hypercalcemia (calcium \>2.63 mmol/l) or hypocalcemia (\<1.75 mmol/l)
* Renal insufficiency (creatinine \>133 μmol/l or GFR \<50 ml/min)
* Primary hyperparathyroidism
* Malignancy
* Infection e.g. human immunodeficiency virus
* Medical conditions requiring daily calcium supplements or antacid use
* Known hypersensitivity to cholecalciferol
* No capability to consent
* Imprisoned persons

Primary outcomes:
measure: 25-hydroxy vitamin D levels
timeFrame: 24 weeks postoperatively
Secondary outcomes:
measure: Prevalence of sufficient vitamin D
timeFrame: 24 weeks postoperatively
measure: Prevalence of vitamin D deficiency
timeFrame: 24 weeks postoperatively
measure: Co-morbidities
timeFrame: 24 weeks postoperatively
measure: Prescribed medication
timeFrame: 24 weeks postoperatively
measure: Body weight, body composition
timeFrame: 24 weeks postoperatively
measure: Blood pressure
timeFrame: 24 weeks postoperatively
measure: Laboratory parameters
timeFrame: 24 weeks postoperatively
measure: Depression symptoms
timeFrame: 24 weeks postoperatively
measure: Bone mineral density and body fat content
timeFrame: 24 weeks postoperatively
measure: Liver condition
timeFrame: 24 weeks postoperatively
measure: Dietary assessment
timeFrame: 24 weeks postoperatively
measure: Gut microbiota composition
timeFrame: 24 weeks postoperatively
measure: Vitamin D in adipose and liver tissue
timeFrame: during surgery
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Division of Endocrinology & Metabolism, Department of Internal Medicine III, Medical University of Vienna
name: Bernhard Ludvik, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kruschitz R, Wakolbinger M, Schindler K, Prager G, Hoppichler F, Marculescu R, Ludvik B. Effect of one-anastomosis gastric bypass on cardiovascular risk factors in patients with vitamin D deficiency and morbid obesity: A secondary analysis. Nutr Metab Cardiovasc Dis. 2020 Nov 27;30(12):2379-2388. doi: 10.1016/j.numecd.2020.08.011. Epub 2020 Aug 20.
citation: Luger M, Kruschitz R, Winzer E, Schindler K, Grabovac I, Kainberger F, Krebs M, Hoppichler F, Langer F, Prager G, Marculescu R, Ludvik B. Changes in Bone Mineral Density Following Weight Loss Induced by One-Anastomosis Gastric Bypass in Patients with Vitamin D Supplementation. Obes Surg. 2018 Nov;28(11):3454-3465. doi: 10.1007/s11695-018-3353-2.
citation: Luger M, Kruschitz R, Kienbacher C, Traussnigg S, Langer FB, Prager G, Schindler K, Kallay E, Hoppichler F, Trauner M, Krebs M, Marculescu R, Ludvik B. 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. Obes Surg. 2017 May;27(5):1196-1207. doi: 10.1007/s11695-016-2437-0.
citation: Luger M, Kruschitz R, Kienbacher C, Traussnigg S, Langer FB, Schindler K, Wurger T, Wrba F, Trauner M, Prager G, Ludvik B. Prevalence of Liver Fibrosis and its Association with Non-invasive Fibrosis and Metabolic Markers in Morbidly Obese Patients with Vitamin D Deficiency. Obes Surg. 2016 Oct;26(10):2425-32. doi: 10.1007/s11695-016-2123-2.
citation: Luger M, Kruschitz R, Marculescu R, Haslacher H, Hoppichler F, Kallay E, Kienbacher C, Klammer C, Kral M, Langer F, Luger E, Prager G, Trauner M, Traussnigg S, Wurger T, Schindler K, Ludvik B. 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. doi: 10.1186/s13063-015-0877-9.