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

Bariatric Surgery Candidate Clinical Trial

— LOAD  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02092376
• Other study ID #: LOAD
• Secondary ID: 2013-003546-16
• Status: Completed
• Phase: Phase 4
• First received: March 17, 2014
• Last updated: July 13, 2016
• Start date: March 2014
• Est. completion date: June 2016

Study information

• Verified date: July 2016
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Office for Safety in Health Care
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 100 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bariatric Surgery Candidate

Intervention

Drug:
• Cholecalciferol

• Placebo

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Maria Luger

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	24 weeks postoperatively	No
Secondary	Prevalence of sufficient vitamin D	Number of patients reaching 25-hydroxyvitamin D levels above 75 nmol/l	24 weeks postoperatively	No
Secondary	Prevalence of vitamin D deficiency	Prevalence of vitamin D deficiency	24 weeks postoperatively	No
Secondary	Co-morbidities	Prevalence of Co-morbidities	24 weeks postoperatively	No
Secondary	Prescribed medication	Change in prescribed medication	24 weeks postoperatively	No
Secondary	Body weight, body composition	Change in body weight and body composition by bioelectrical impedance analysis	24 weeks postoperatively	No
Secondary	Blood pressure	Change of vital signs (blood pressure)	24 weeks postoperatively	No
Secondary	Laboratory parameters	Change in laboratory parameters compared to baseline: vitamin D status, bone turnover markers, calcium homeostasis, parathyroid hormone, inflammation, insulin resistance	24 weeks postoperatively	No
Secondary	Depression symptoms	Prevalence of depression symptoms assessed by Beck Depression Inventory Questionnaire	24 weeks postoperatively	No
Secondary	Bone mineral density and body fat content	Assessment of bone mineral density and total body fat content by DEXA	24 weeks postoperatively	No
Secondary	Liver condition	Measurement of liver stiffness and fat content by FibroScan and CAP	24 weeks postoperatively	No
Secondary	Dietary assessment	Dietary assessment will be documented with a 5-day food record to calculate vitamin D intake and the Mediterranean Score (questionnaire with calculated score)	24 weeks postoperatively	No
Secondary	Gut microbiota composition	Association between vitamin D, gut microbiota and surgery-induced weight loss, by collecting stool samples	24 weeks postoperatively	No
Secondary	Vitamin D in adipose and liver tissue	For instance, for the purposes of describing adipose depot vitamin D concentrations and expression of enzymes in subcutaneous, visceral adipose and liver tissue samples will be collected during the omega loop gastric bypass surgery. Furthermore, the liver tissue samples should be used in addition for a histological examination as extended diagnostics (NAFLD/ NASH).	during surgery	No