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

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.

Conditions

• Vitamin D Deficiency
• Vitamin D Insufficiency

Interventions

DIETARY_SUPPLEMENT

Vitamin D

10,000 IU of VitD3 daily (one gel daily)

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.

Sponsors & Collaborators

• Bariatric Advantage

  collaborator UNKNOWN

• Johns Hopkins University

  lead OTHER

Principal Investigators

• Kimberley E Steele, MD, PhD · Johns Hopkins University

• Michael A. Schweitzer, MD · Johns Hopkins University

• Thomas H Magnuson, MD · Johns Hopkins University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

64 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-01-31

Primary Completion

2017-04-30

Completion

2017-04-30

Countries

• United States

Study Locations