Laporoscopic Sleeve-Gastrectomy E66
Conditions
Interventions
Group 1: Patients assigned to the vitamin D group supplemented 80 µg vitamin D3 by an oily suspension for 12 weeks (wk) once daily. This suspension was prepared by diluting Vigantol oil ® with Miglyol
Sponsors
Klinikum Vest GmbH
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: • Indication for sleeve-gastrectomy according to the current S3-guideline "Surgery of Obesity" (CA-ADIP, 2010): BMI > 40 kg/m2 after exhausting conservative treatment methods, or BMI > 35 kg/m2 with one or more obesity-associated comorbidities exhaustion of conservative treatment methods • Written informed consent • Voluntary participation
Exclusion criteria
Exclusion criteria: • Previous surgery of the stomach • Malignancies and chronic diseases such as liver cirrhosis • Unstable psychopathological states, active substance dependence, and untreated bulimia nervosa • Known pregnancy or lactation • Ingestion of dietary supplements (e.g., vitamins) • Hypercalcaemia • Kidney stones • Mental illness, cast doubt on the ability to understand business-capacity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum 25-OHD-concentration. Serum 25-OHD was measured using an ELISA kit (IDS, Frankfurt/Main, Germany) at baseline and 4 and 12 weeks after bariatric surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| Laboratory values: - PTH (IMMULITE 2000 Intact PTH), - calcium, phosphat, magnesium (photometry) - alkaline phosphatase, creatinine, albumin, CRP, HbA1c, glucose, cholesterol, HDL, LDL, triglycerides (routine clinical chemistry) - TNF-alpha (ELISA) - retinol, ascorbic acid, tocopherol, ß-carotene (HPLC). Blood analysis was done at baseline and 4 and 12 weeks after surgery. Antrophometric data: Body height (at baseline) and Body weight (at baseline, 4 and 12 weeks after surgery) Nutritional intake: 3 day food records at baseline and 3 and 11 weeks after surgery. The daily intake of energy, macronutrients, and vitamin D was calculated using DGE-PC professional software, version 4.0, based on the German Nutrient Data Base (BLS, Bundeslebensmittelschlussel) II.3. Quality of life: BAROS-questionnaire at baseline and 4 and 12 weeks after surgery (B.A.R.O.S. = Bariatric reporting and outcome system) Compliance The patients were asked to document the intake of the oily preparations in a pre-build diary which allowed us to determine the total amount of preparations ingested during intervention. All patients received the same number of single-dose ophtiols and were requested to bring the remaining ophtiols back. The number of ingested preparations was additionally determined as difference between provided and returned single-dose ophtiols in wk4 and wk12. | — |
Countries
Germany
Contacts
Public ContactEva Wolf
Klinikum Vest GmbH
Outcome results
None listed