Status:
TERMINATED
Vitamin D to Improve Nutrition Prior to Bariatric Surgery and Investigate the Relationship With Negative Outcomes
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Bariatric Advantage
Conditions:
Vitamin D Deficiency
Vitamin D Insufficiency
Eligibility:
All Genders
18-64 years
Phase:
NA
Brief Summary
VISTA is looking to see if vitamin D supplements before bariatric surgery might improve vitamin D stores, which may help to prevent some complications like infections. Who can join this research stud...
Detailed Description
An estimated 2 in 3 American adults are either overweight (BMI 25-29.9 kg/m2) or obese (BMI 30-39.9 kg/m2). The prevalence of obesity, morbid obesity (BMI 40-44.9 kg/m2), and even super obesity (BMI ≥...
Eligibility Criteria
Inclusion
- Patients approved for and undergoing clinically indicated bariatric surgery -Roux-en-Y Gastric Bypass (RYGBP) or Vertical Sleeve Gastrectomy (VSG)
- 18 to 64 years of age
- BMI of 35 to 49.9 kg/m2
- VitD insufficient pre-operatively: serum 25(OH)D concentration \< 75 nmol/L or 30 ng/ml
Exclusion
- Any patient who does not want to participate in the study
- Any patient who has dietary restrictions/proscriptions prohibiting ingestion of beef gelatin
- Expected poor compliance with the medical regimen
- Any active medical conditions that could, in the opinion of the investigators, jeopardize the safety of the subject or the integrity of the study
- The elective bariatric surgery is cancelled prior to incision by a surgeon for any reason
- Pregnancy: The routine standard of care is to determine whether a female patient is pregnant either by history and/or urinary pregnancy test on the day of surgery. No additional testing specifically for this study is planned beyond the standard of care.
Key Trial Info
Start Date :
January 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2017
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT02212652
Start Date
January 1 2017
End Date
April 1 2017
Last Update
June 6 2019
Active Locations (1)
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1
The Johns Hopkins Center for Bariatric Surgery
Baltimore, Maryland, United States, 21224