A Phase 4 interventional study of Cholecalciferol and Placebo in Bariatric Surgery Candidate, sponsored by Maria Luger. Completed at 1 site in Austria. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2016-07-14.
Sponsored by Maria Luger · Phase 4, Interventional, and Treatment
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.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's enrollment of 50 is below the median of 78 across 4,878 interventional studies indexed under Obesity.
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Exclusion Criteria:
The loading dose of 300 000 IU is divided into three doses (100 000 IU) and will be given over the first months. All patients in the intervention group will receive the first loading dose of 100 000 IU at day of discharge. The second (2 weeks) and third (4 weeks postoperative) administration will be given based on the 25-hydroxy vitamin D concentration. After the last respectively third loading dose a maintenance dose of 3420 IU per day should maintain the high 25-hydroxy vitamin D concentration. It should be administered for up to 46 weeks (until follow-up visit)
Drug: Cholecalciferol
The placebo loading dose (oil) is divided into three administrations and will be given over the first months. All patients in the placebo group will receive the first placebo loading dose at day of discharge. After the last placebo loading dose a maintenance dose of 3420 IU per day should maintain the 25-hydroxy vitamin D concentration. It should be administered for up to 46 weeks (until follow-up).
Drug: Placebo
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
Time frame: 24 weeks postoperatively
Prevalence of sufficient vitamin D
Number of patients reaching 25-hydroxyvitamin D levels above 75 nmol/l
Time frame: 24 weeks postoperatively
Prevalence of vitamin D deficiency
Prevalence of vitamin D deficiency
Time frame: 24 weeks postoperatively
Co-morbidities
Prevalence of Co-morbidities
Time frame: 24 weeks postoperatively
Prescribed medication
Change in prescribed medication
Time frame: 24 weeks postoperatively
Body weight, body composition
Change in body weight and body composition by bioelectrical impedance analysis
Time frame: 24 weeks postoperatively
Blood pressure
Change of vital signs (blood pressure)
Time frame: 24 weeks postoperatively
Laboratory parameters
Change in laboratory parameters compared to baseline: vitamin D status, bone turnover markers, calcium homeostasis, parathyroid hormone, inflammation, insulin resistance
Time frame: 24 weeks postoperatively
Depression symptoms
Prevalence of depression symptoms assessed by Beck Depression Inventory Questionnaire
Time frame: 24 weeks postoperatively
Bone mineral density and body fat content
Assessment of bone mineral density and total body fat content by DEXA
Time frame: 24 weeks postoperatively
Liver condition
Measurement of liver stiffness and fat content by FibroScan and CAP
Time frame: 24 weeks postoperatively
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)
Time frame: 24 weeks postoperatively
Gut microbiota composition
Association between vitamin D, gut microbiota and surgery-induced weight loss, by collecting stool samples
Time frame: 24 weeks postoperatively
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).
Time frame: during surgery
This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.
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