The aim of the study is to increase vitamin D concentrations respectively to keep it on high level by supplementing with cholecalciferol 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 and depression score of bariatric patients are expected to improve, due to supplementation of a loading dose compared to the standard therapy.
Conditions
Interventions
Trade Name: Oleovit D3-Tropfen
Product Name: Oleovit D3-Tropfen
Pharmaceutical Form: Oral drops
INN or Proposed INN: Colecalciferol
CAS Number: 0000067-97-0
Current Sponsor code: not applicable
Other
Sponsors
Medizinische Universität Wien, Klin. Abt. für Endokrinologie & Stoffwechsel, Universitätsklinik für Innere Medizin III
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Men and women over the age of 18 and under 100 years Planned omega loop bypass surgery 25-OHD 40 or = 35 kg/m2 with co-morbidities e.g. diabetes mellitus and hypertension Body weight =65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: Another planned form of bariatric surgery Hypercalcemia (calcium > 2.63 mmol/l) or hypocalcemia (calcium 133 µmol/l or GFR < 50 ml/min) Primary hyperparathyroidism Malignancy infection e.g. human immunodeficiency virus (HIV) Medical conditions requiring daily calcium supplements or antacid use Known hypersensitivity to cholecalciferol No capability to consent Imprisoned persons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To test whether administering up to three doses of 100 000 IU vitamin D3 in the first month postoperatively (loading dose), followed by 3420 IU/day (intervention group LMD) in bariatric patients will increase significantly 25-hydroxyvitamin D levels 24 weeks after surgery, compared with a control group receiving placebo, followed by the standard daily doses of 3420 IU/ day (control group ST).;Secondary Objective: • Number of patients reaching 25-hydroxyvitamin D levels above 75 nmol/l in both groups (placebo and intervention) • Prevalence of vitamin D deficiency in morbidly obese bariatric patients • The expression of the 25-hydroxylases: CYP27A1, CYP2R1, CYP2J2, CYP3A4, CYP2C11, CYP27B1 (1a-hydroxylase), 24-hydroxylase (CYP24A1) and VDR genes by adipocytes in morbidly obese patients • Measurement of vitamin D concentrations in two adipose tissue depots, visceral (VAT) and subcutaneous adipose tissue (SAT), and liver tissue at the time of omega loop bypass surgery (vitamin D storage in adipose and liver tissue) • Change in body fat mass: by Dual energy X-Ray absorptiometry DEXA • Change in blood pressure: systolic and diastolic (mmHg) • Change in food intake: 5-day food record and Mediterranean Score • Change in depression symptoms: Beck Depression Inventory (BDI Score);Primary end point(s): 25-OHD levels (nmol/l) after 24 weeks measured in intervention and control group, adjusting for the baseline value as covariate.;Timepoint(s) of evaluation of this end point: 24 weeks postoperatively | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Changes after 24 weeks between intervention and control group: • Number of patients reaching 25-hydroxyvitamin D levels above 75 nmol/l • Prevalence of vitamin D deficiency • Co-morbidities, • Prescribed medication, • Body weight, body composition (lean body mass and fat), • Vital signs (blood pressure), • Laboratory parameter, • Depression symptoms (BDI score), • Bone mineral density and structure (DEXA and qCT), • Liver condition (FibroScan® and CAPTM), • Dietary assessment.;Timepoint(s) of evaluation of this end point: 24 weeks postoperatively | — |
Countries
Austria
Contacts
Public ContactMaria Luger
Medizinische Universität Wien, Klin. Abt. für Endokrinologie & Stoffwechsel, Universitätsklinik für Innere Medizin III
Outcome results
None listed