Vitamin D Deficiency Clinical Trial
— VISTAOfficial title:
The Effect of VItamin D Supplementation on Nutritional STatus and Adverse Outcomes in Bariatric Surgery (VISTA)
NCT number | NCT02212652 |
Other study ID # | IRB00044789 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | January 2017 |
Est. completion date | April 2017 |
Verified date | June 2019 |
Source | Johns Hopkins University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 70 |
Est. completion date | April 2017 |
Est. primary completion date | April 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 64 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | The Johns Hopkins Center for Bariatric Surgery | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University | Bariatric Advantage |
United States,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Adverse surgical outcomes (aggregate) | 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. | Up to 30 days after surgery | |
Secondary | Clinical outcomes (aggregate) | 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. | Up to 12 months after surgery |
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