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

NCT02212652 | Terminated

• 1 other identifier: IRB00044789
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitamin D Deficiency; Vitamin D Insufficiency

Keywords

Bariatric surgery; Vitamin D deficiency; Vitamin D insufficiency; Adverse surgical outcomes; Clinical outcomes

Outcome Measures

Primary Outcomes (1)

• Vitamin D status as measured by serum 25(OH)D concentration.

  Improved post-operative vitamin D status as measured by serum 25(OH)D concentration.

  Up to 12 months after surgery

Secondary Outcomes (2)

• Adverse surgical outcomes (aggregate)

  Up to 30 days after surgery

• Clinical outcomes (aggregate)

  Up to 12 months after surgery

Study Arms (2)

Standard of Care plus Vitamin D

ACTIVE COMPARATOR

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; Other: Standard of Care

Standard of Care plus Placebo

PLACEBO COMPARATOR

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; Other: Standard of Care

Interventions

Vitamin D DIETARY_SUPPLEMENT

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

Also known as: Bariatric Advantage Vitamin D Chewable Gels

Standard of Care plus Vitamin D

Placebo OTHER

Gummy button placebo, which will appear very similar to the vitamin D supplement.

Standard of Care plus Placebo

Standard of Care OTHER

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

Standard of Care plus Placebo; Standard of Care plus Vitamin D

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients approved for and undergoing clinically indicated bariatric surgery -Roux-en-Y Gastric Bypass (RYGBP) or Vertical Sleeve Gastrectomy (VSG)
• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• Bariatric Advantage: collaborator

Study Sites (1)

The Johns Hopkins Center for Bariatric Surgery

Baltimore, Maryland, 21224, United States

Location

Related Publications (4)

• Quraishi SA, Bittner EA, Blum L, Hutter MM, Camargo CA Jr. Association between preoperative 25-hydroxyvitamin D level and hospital-acquired infections following Roux-en-Y gastric bypass surgery. JAMA Surg. 2014 Feb;149(2):112-8. doi: 10.1001/jamasurg.2013.3176.

  PMID: 24284777 BACKGROUND

• Goldner WS, Stoner JA, Lyden E, Thompson J, Taylor K, Larson L, Erickson J, McBride C. Finding the optimal dose of vitamin D following Roux-en-Y gastric bypass: a prospective, randomized pilot clinical trial. Obes Surg. 2009 Feb;19(2):173-179. doi: 10.1007/s11695-008-9680-y. Epub 2008 Sep 16.

  PMID: 18795378 BACKGROUND

• Lin E, Armstrong-Moore D, Liang Z, Sweeney JF, Torres WE, Ziegler TR, Tangpricha V, Gletsu-Miller N. Contribution of adipose tissue to plasma 25-hydroxyvitamin D concentrations during weight loss following gastric bypass surgery. Obesity (Silver Spring). 2011 Mar;19(3):588-94. doi: 10.1038/oby.2010.239. Epub 2010 Oct 14.

  PMID: 20948527 BACKGROUND

• Nguyen S, Baggerly L, French C, Heaney RP, Gorham ED, Garland CF. 25-Hydroxyvitamin D in the range of 20 to 100 ng/mL and incidence of kidney stones. Am J Public Health. 2014 Sep;104(9):1783-7. doi: 10.2105/AJPH.2013.301368. Epub 2013 Oct 17.

  PMID: 24134366 BACKGROUND

Related Links

• The Johns Hopkins Center for Bariatric Surgery

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Vitamin D; Standard of Care

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Kimberley E Steele, MD, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• Michael A. Schweitzer, MD

  Johns Hopkins University

  STUDY DIRECTOR

• Thomas H Magnuson, MD

  Johns Hopkins University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2014
• First Posted: August 8, 2014
• Study Start: January 1, 2017
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: June 6, 2019

Record last verified: 2019-06

Locations

US (1)