Efficacy of Vitamin D Supplementation in Bariatric Surgery Patients

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ClinicalTrials.gov Identifier: NCT01385098

Recruitment Status : Completed

First Posted : June 29, 2011

Results First Posted : January 23, 2018

Last Update Posted : January 23, 2018

Sponsor:

Collaborators:

Texas Woman's University

The Methodist Hospital System

Information provided by (Responsible Party):

Vadim Sherman, MD, The Methodist Hospital System

Study Description

Brief Summary:

As the use of bariatric surgery for treatment of extreme obesity adults continues to rise, clinicians must be aware of pre-existing nutritional deficiencies in overweight and obese patients. Nutritional deficiencies are common in patients undergoing bariatric surgery and these deficiencies should be detected and addressed early to avoid post-operative complications. To improve long-term outcomes following bariatric surgery, nutritional screening and prescribing appropriate supplementation to prevent nutrient deficiencies is needed. Vitamin D deficiency is common following bariatric surgery and has been reported to occur in 50-80% bariatric patients.The goal of this pilot study is to help develop nutrient supplementation interventions following two types of bariatric surgery: Roux-en Y gastric bypass and sleeve gastrectomy.

Recently, several studies in adults have revealed an inverse relationship between body fat and blood 25-hydroxyvitamin D3 [25(OH)D] levels, the relevant marker of low vitamin D status. Although vitamin D is well known for its essential role in bone metabolism and calcium homeostasis, increasing evidence is linking vitamin D to obesity. This study will evaluate vitamin D status during post operative daily supplementation of 2,000 IU of vitamin D3 and 1500 mg of calcium through assessment of changes in serum 25(OH)D, parathyroid hormone (PTH), calcium and phosphorus at baseline, 4 weeks, and 12 weeks following surgery. The dietary contribution of vitamin D and calcium will be estimated by food records analyzed using the University of Minnesota 2010 Nutrition Data System for Research (NDSR) program.

Primary Hypothesis: Daily supplementation with 2,000 IU of vitamin D3 for 12 weeks will significantly increase mean serum 25(OH)D levels in obese subjects following bariatric surgery compared to baseline levels.

Secondary Hypothesis: The percent response above baseline to daily supplementation with 2,000 IU of vitamin D3 will significantly differ between Roux-en Y and sleeve gastrectomy patients.

Condition or disease	Intervention/treatment	Phase
Obesity Vitamin D Deficiency	Dietary Supplement: Vitamin D3 and Calcium	Not Applicable

Show Detailed Description

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	37 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Preoperative Vitamin D Status and Efficacy of Therapeutic Vitamin D Supplementation Postoperatively in Bariatric Surgery Patients
Study Start Date :	July 2011
Actual Primary Completion Date :	May 2013
Actual Study Completion Date :	September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium Vitamin D Vitamin D Deficiency Weight Loss Surgery

Drug Information available for: Cholecalciferol Calcium Gluconate Vitamin D

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Vitamin D3 and Calcium Dietary supplement of vitamin D3 and calcium	Dietary Supplement: Vitamin D3 and Calcium 1500 mg of calcium citrate plus 1000 IU of vitamin D3 and 1000 IU of vitamin D3 bariatric supplements per day Other Names: Celebrate ® calcium citrate plus vitamin D3 Celbrate ® multi-vitamin

Outcome Measures

Primary Outcome Measures :

Vitamin D Concentrations, Pre Operative and Post Bariatric Surgery Following 12 Weeks of Vitamin D Supplementation [ Time Frame: baseline and 12 weeks ]
Serum 25(OH)D ng/ml levels at baseline and 12 weeks following bariatric surgery

Secondary Outcome Measures :

Serum 25-hydroxyvitamin D Levels at Baseline and 12 Weeks of Daily Vit D Supplementation Post Roux-en Y OR Sleeve Gastrectomy [ Time Frame: Baseline and 12 weeks ]
We anticipate that vitamin D supplementation of Roux-en Y bariatric surgery patients will be less effective in improving or maintaining vitamin D status.

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria: Adult female obese patients undergoing either Roux-en Y gastric bypass or sleeve gastrectomy at The Methodist Hospital may participate in the study. Obese patients with a body mass index (BMI) > 40 or BMI >35 with a co-morbidity will be eligible.

Exclusion Criteria:Subjects will be excluded if they have evidence of vitamin D deficiency (< 20 ng/mL), hypercalcemia (calcium > 2.63 mmol/L), hypocalcemia (calcium < 1.75 mmol/L), renal insufficiency (GFR < 50 ml/min), or a history of primary hyperparathyroidism or renal tubular acidosis.Participants will be excluded if they take medications that interfere with vitamin D metabolism, have significant sun exposure, plan to travel to sunny climates during the study, or a history of hypercalcemia.

Contacts and Locations

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): NCT01385098

Locations


United States, Texas
The Methodist Hospital
Houston, Texas, United States, 77030

Sponsors and Collaborators

Vadim Sherman, MD

Texas Woman's University

The Methodist Hospital System

Investigators


Study Chair:	Susan Miller, MD	The Methodist Hospital Research Institute
Principal Investigator:	Vadim Sherman, MD	The Methodist Hospital Research Institute

More Information

Publications of Results:

Moore CE, Sherman V. Vitamin D supplementation efficacy: sleeve gastrectomy versus gastric bypass surgery. Obes Surg. 2014 Dec;24(12):2055-60. doi: 10.1007/s11695-014-1261-7.

Other Publications:

Carlin AM, Rao DS, Yager KM, Parikh NJ, Kapke A. Treatment of vitamin D depletion after Roux-en-Y gastric bypass: a randomized prospective clinical trial. Surg Obes Relat Dis. 2009 Jul-Aug;5(4):444-9. doi: 10.1016/j.soard.2008.08.004. Epub 2008 Aug 14.

Compher CW, Badellino KO, Boullata JI. Vitamin D and the bariatric surgical patient: a review. Obes Surg. 2008 Feb;18(2):220-4. doi: 10.1007/s11695-007-9289-6. Epub 2008 Jan 5. Review.

Gemmel K, Santry HP, Prachand VN, Alverdy JC. Vitamin D deficiency in preoperative bariatric surgery patients. Surg Obes Relat Dis. 2009 Jan-Feb;5(1):54-9. doi: 10.1016/j.soard.2008.07.008. Epub 2008 Jul 24.

Mechanick JI, Kushner RF, Sugerman HJ, Gonzalez-Campoy JM, Collazo-Clavell ML, Guven S, Spitz AF, Apovian CM, Livingston EH, Brolin R, Sarwer DB, Anderson WA, Dixon J. American Association of Clinical Endocrinologists, The Obesity Society, and American Society for Metabolic & Bariatric Surgery Medical Guidelines for Clinical Practice for the perioperative nutritional, metabolic, and nonsurgical support of the bariatric surgery patient. Surg Obes Relat Dis. 2008 Sep-Oct;4(5 Suppl):S109-84. doi: 10.1016/j.soard.2008.08.009. Epub 2008 Aug 19. Erratum in: Surg Obes Relat Dis. 2010 Jan-Feb;6(1):112.

Gastrointestinal surgery for severe obesity: National Institutes of Health Consensus Development Conference Statement. Am J Clin Nutr. 1992 Feb;55(2 Suppl):615S-619S. doi: 10.1093/ajcn/55.2.615s.


Responsible Party:	Vadim Sherman, MD, Sponsor-Investigator/Principal Investigator, The Methodist Hospital System
ClinicalTrials.gov Identifier:	NCT01385098 History of Changes
Other Study ID Numbers:	Pro00005625 0311-0034 ( Other Identifier: HMRI IRB )
First Posted:	June 29, 2011 Key Record Dates
Results First Posted:	January 23, 2018
Last Update Posted:	January 23, 2018
Last Verified:	January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No


Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		No

Keywords provided by Vadim Sherman, MD, The Methodist Hospital System:


Vitamin D Bariatric surgery Roux-en Y surgery Gastric sleeve surgery Parathyroid Hormone

Additional relevant MeSH terms:


Vitamin D Deficiency Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Vitamins Vitamin D	Ergocalciferols Cholecalciferol Calcium, Dietary Micronutrients Growth Substances Physiological Effects of Drugs Bone Density Conservation Agents

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