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

Stopped early · Not applicable · Has a placebo group

Conditions studied: Vitamin D Deficiency, Vitamin D Insufficiency

In brief

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.

Key facts

Study ID

NCT02212652

Run by

Johns Hopkins University

People needed

70

Starts

2017-01-01

Expected to finish

2017-04-01

Last updated by the study team

2019-06-06

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• The Johns Hopkins Center for Bariatric Surgery — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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