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Vitamin D to Improve Nutrition Prior to Bariatric Surgery and Investigate the Relationship With Negative Outcomes (VISTA)

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ClinicalTrials.gov Identifier: NCT02212652
Recruitment Status : Suspended (Currently suspended pending staff hiring)
First Posted : August 8, 2014
Last Update Posted : December 14, 2017
Sponsor:
Collaborator:
Bariatric Advantage
Information provided by (Responsible Party):
Johns Hopkins University

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 study?

  • Approved to undergo bariatric surgery—Roux-en-Y Gastric Bypass or Vertical Sleeve Gastrectomy—at the Johns Hopkins Bayview Medical Center
  • 18 to 64 years of age
  • BMI of 35 to 49.9 kg/m2
  • VitD insufficient or deficient prior to having surgery

What will happen if a participant chooses to participate in this research study?

  • The participant will be randomly assigned (by chance) to receive either:
  • Standard care plus vitamin D supplements or
  • Standard care plus a placebo (contains no vitamin D)
  • Either would be provided at no cost to the participant
  • The investigators will ask the participant to complete a survey on the day of surgery regarding supplement use
  • The investigators will follow the participants medical record through the 12 month follow up clinic visit.

Condition or disease Intervention/treatment Phase
Vitamin D Deficiency Vitamin D Insufficiency Dietary Supplement: Vitamin D Other: Placebo Other: Standard of Care Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of VItamin D Supplementation on Nutritional STatus and Adverse Outcomes in Bariatric Surgery (VISTA)
Actual Study Start Date : January 2017
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

Arm Intervention/treatment
Active Comparator: Standard of Care plus Vitamin D
If randomized to this arm, each participant will receive a 30 day supply of 10,000 IU of VitD3 for research purposes in addition to receiving standard of care. We will ask that they take one of these supplements daily with their largest meal of the day until their surgery.
Dietary Supplement: Vitamin D
10,000 IU of VitD3 daily (one gel daily)
Other Name: Bariatric Advantage Vitamin D Chewable Gels

Other: Standard of Care
Patients will receive the standard care provided to all patients undergoing bariatric surgery regardless of research study participation status.

Placebo Comparator: Standard of Care plus Placebo
If randomized to this arm, each participant will receive a 30 day supply of placebo supplements for research purposes in addition to receiving standard of care. We will ask that they take one of these supplements daily with their largest meal of the day until their surgery.
Other: Placebo
Gummy button placebo, which will appear very similar to the vitamin D supplement.

Other: Standard of Care
Patients will receive the standard care provided to all patients undergoing bariatric surgery regardless of research study participation status.




Primary Outcome Measures :
  1. Vitamin D status as measured by serum 25(OH)D concentration. [ Time Frame: Up to 12 months after surgery ]
    Improved post-operative vitamin D status as measured by serum 25(OH)D concentration.


Secondary Outcome Measures :
  1. Adverse surgical outcomes (aggregate) [ Time Frame: Up to 30 days after surgery ]
    Adverse surgical outcomes include surgical site infection, wound separation and dehiscence, anastomotic leak, prolonged length of hospital stay (> 3 days), and re-admittance to the hospital within 30 days post-operatively.

  2. Clinical outcomes (aggregate) [ Time Frame: Up to 12 months after surgery ]
    Long-term clinical outcomes include wound healing, weight loss, nutritional status, resolution of comorbidities, and other key markers of health, such as vital signs (fever, blood pressure, heart rate, pain, etc.) and return of a regular menstrual cycle.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.

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): NCT02212652


Locations
United States, Maryland
The Johns Hopkins Center for Bariatric Surgery
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
Bariatric Advantage
Investigators
Principal Investigator: Kimberley E Steele, MD, PhD Johns Hopkins University
Study Director: Michael A. Schweitzer, MD Johns Hopkins University
Study Director: Thomas H Magnuson, MD Johns Hopkins University

Additional Information:
Publications:
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02212652     History of Changes
Other Study ID Numbers: IRB00044789
First Posted: August 8, 2014    Key Record Dates
Last Update Posted: December 14, 2017
Last Verified: December 2017

Keywords provided by Johns Hopkins University:
Bariatric surgery
Vitamin D deficiency
Vitamin D insufficiency
Adverse surgical outcomes
Clinical outcomes

Additional relevant MeSH terms:
Vitamin D Deficiency
Vitamins
Vitamin D
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Ergocalciferols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents