The Link Between Obesity And Vitamin D in Bariatric Patients With Omega-loop Bypass Surgery

Phase 4CompletedNCT02092376

Maria Luger50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Bariatric Surgery Candidate

Interventions

CholecalciferolDRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

Locations (1)

Medical University of Vienna

Vienna, Vienna, Austria

Outcomes

Primary Outcomes

25-hydroxy vitamin D levels

25-hydroxy vitamin D levels after 24 weeks measured in intervention and placebo group, adjusting for the baseline value as covariate