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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02092376
Recruitment Status : Completed
First Posted : March 20, 2014
Last Update Posted : July 14, 2016
Sponsor:
Information provided by (Responsible Party):
Maria Luger, Medical University of Vienna

Tracking Information
First Submitted Date  ICMJE March 17, 2014
First Posted Date  ICMJE March 20, 2014
Last Update Posted Date July 14, 2016
Study Start Date  ICMJE March 2014
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 19, 2014)
25-hydroxy vitamin D levels [ Time Frame: 24 weeks postoperatively ]
25-hydroxy vitamin D levels after 24 weeks measured in intervention and placebo group, adjusting for the baseline value as covariate
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 19, 2014)
  • Prevalence of sufficient vitamin D [ Time Frame: 24 weeks postoperatively ]
    Number of patients reaching 25-hydroxyvitamin D levels above 75 nmol/l
  • Prevalence of vitamin D deficiency [ Time Frame: 24 weeks postoperatively ]
    Prevalence of vitamin D deficiency
  • Co-morbidities [ Time Frame: 24 weeks postoperatively ]
    Prevalence of Co-morbidities
  • Prescribed medication [ Time Frame: 24 weeks postoperatively ]
    Change in prescribed medication
  • Body weight, body composition [ Time Frame: 24 weeks postoperatively ]
    Change in body weight and body composition by bioelectrical impedance analysis
  • Blood pressure [ Time Frame: 24 weeks postoperatively ]
    Change of vital signs (blood pressure)
  • Laboratory parameters [ Time Frame: 24 weeks postoperatively ]
    Change in laboratory parameters compared to baseline: vitamin D status, bone turnover markers, calcium homeostasis, parathyroid hormone, inflammation, insulin resistance
  • Depression symptoms [ Time Frame: 24 weeks postoperatively ]
    Prevalence of depression symptoms assessed by Beck Depression Inventory Questionnaire
  • Bone mineral density and body fat content [ Time Frame: 24 weeks postoperatively ]
    Assessment of bone mineral density and total body fat content by DEXA
  • Liver condition [ Time Frame: 24 weeks postoperatively ]
    Measurement of liver stiffness and fat content by FibroScan and CAP
  • Dietary assessment [ Time Frame: 24 weeks postoperatively ]
    Dietary assessment will be documented with a 5-day food record to calculate vitamin D intake and the Mediterranean Score (questionnaire with calculated score)
  • Gut microbiota composition [ Time Frame: 24 weeks postoperatively ]
    Association between vitamin D, gut microbiota and surgery-induced weight loss, by collecting stool samples
  • Vitamin D in adipose and liver tissue [ Time Frame: during surgery ]
    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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Link Between Obesity And Vitamin D in Bariatric Patients With Omega-loop Bypass Surgery
Official Title  ICMJE The Link Between Obesity And Vitamin D in Bariatric Patients With Omega-loop Bypass Surgery: a Randomized Controlled, Double-blinded Clinical Supplementation Trial
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Bariatric Surgery Candidate
Intervention  ICMJE
  • Drug: Cholecalciferol
  • Drug: Placebo
Study Arms  ICMJE
  • Active Comparator: Intervention
    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)
    Intervention: Drug: Cholecalciferol
  • Placebo Comparator: Placebo
    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).
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 19, 2014)
50
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2016
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02092376
Other Study ID Numbers  ICMJE LOAD
2013-003546-16 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Maria Luger, Medical University of Vienna
Study Sponsor  ICMJE Maria Luger
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Bernhard Ludvik, M.D. Division of Endocrinology & Metabolism, Department of Internal Medicine III, Medical University of Vienna
PRS Account Medical University of Vienna
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP