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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

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.

Condition or disease Intervention/treatment Phase
Bariatric Surgery Candidate Drug: Cholecalciferol Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : March 2014
Actual Primary Completion Date : October 2015
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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)
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).
Drug: Placebo



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Prevalence of sufficient vitamin D [ Time Frame: 24 weeks postoperatively ]
    Number of patients reaching 25-hydroxyvitamin D levels above 75 nmol/l

  2. Prevalence of vitamin D deficiency [ Time Frame: 24 weeks postoperatively ]
    Prevalence of vitamin D deficiency

  3. Co-morbidities [ Time Frame: 24 weeks postoperatively ]
    Prevalence of Co-morbidities

  4. Prescribed medication [ Time Frame: 24 weeks postoperatively ]
    Change in prescribed medication

  5. Body weight, body composition [ Time Frame: 24 weeks postoperatively ]
    Change in body weight and body composition by bioelectrical impedance analysis

  6. Blood pressure [ Time Frame: 24 weeks postoperatively ]
    Change of vital signs (blood pressure)

  7. 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

  8. Depression symptoms [ Time Frame: 24 weeks postoperatively ]
    Prevalence of depression symptoms assessed by Beck Depression Inventory Questionnaire

  9. Bone mineral density and body fat content [ Time Frame: 24 weeks postoperatively ]
    Assessment of bone mineral density and total body fat content by DEXA

  10. Liver condition [ Time Frame: 24 weeks postoperatively ]
    Measurement of liver stiffness and fat content by FibroScan and CAP

  11. 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)

  12. Gut microbiota composition [ Time Frame: 24 weeks postoperatively ]
    Association between vitamin D, gut microbiota and surgery-induced weight loss, by collecting stool samples

  13. 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).



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02092376


Locations
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Austria
Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Maria Luger
Investigators
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Principal Investigator: Bernhard Ludvik, M.D. Division of Endocrinology & Metabolism, Department of Internal Medicine III, Medical University of Vienna
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Maria Luger, Maria Luger, MSc, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT02092376    
Other Study ID Numbers: LOAD
2013-003546-16 ( EudraCT Number )
First Posted: March 20, 2014    Key Record Dates
Last Update Posted: July 14, 2016
Last Verified: July 2016
Keywords provided by Maria Luger, Medical University of Vienna:
Bariatric surgery
vitamin D
supplementation
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Cholecalciferol
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Nutrients
Growth Substances
Bone Density Conservation Agents