Efficacy of Vitamin D Supplementation in Bariatric Surgery Patients

NCT01385098 | Completed Results

• 2 other identifiers: Pro000056250311-0034
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Vitamin D Deficiency

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Vitamin D Concentrations, Pre Operative and Post Bariatric Surgery Following 12 Weeks of Vitamin D Supplementation

  Serum 25(OH)D ng/ml levels at baseline and 12 weeks following bariatric surgery

  baseline and 12 weeks

Secondary Outcomes (1)

• Serum 25-hydroxyvitamin D Levels at Baseline and 12 Weeks of Daily Vit D Supplementation Post Roux-en Y OR Sleeve Gastrectomy

  Baseline and 12 weeks

Study Arms (1)

Vitamin D3 and Calcium

EXPERIMENTAL

Dietary supplement of vitamin D3 and calcium

Dietary Supplement: Vitamin D3 and Calcium

Interventions

Vitamin D3 and Calcium DIETARY_SUPPLEMENT

1500 mg of calcium citrate plus 1000 IU of vitamin D3 and 1000 IU of vitamin D3 bariatric supplements per day

Also known as: Celebrate ® calcium citrate plus vitamin D3, Celbrate ® multi-vitamin

Vitamin D3 and Calcium

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Vadim Sherman, MD: lead
• Texas Woman's University: collaborator
• The Methodist Hospital Research Institute: collaborator

Study Sites (1)

The Methodist Hospital

Houston, Texas, 77030, United States

Location

Related Publications (7)

• 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.

  PMID: 18996761 BACKGROUND

• 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.

  PMID: 18176832 BACKGROUND

• 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.

  PMID: 18848507 BACKGROUND

• 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.

  PMID: 18848315 BACKGROUND

• 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.

  PMID: 1733140 BACKGROUND

• 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.

  PMID: 24748475 RESULT

• Chakhtoura MT, Nakhoul NF, Akl EA, Safadi BY, Mantzoros CS, Metzendorf MI, El-Hajj Fuleihan G. Oral vitamin D supplementation for adults with obesity undergoing bariatric surgery. Cochrane Database Syst Rev. 2024 Oct 1;10(10):CD011800. doi: 10.1002/14651858.CD011800.pub2.

  PMID: 39351881 DERIVED

MeSH Terms

Conditions

Obesity; Vitamin D Deficiency

Interventions

Cholecalciferol; Calcium

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Avitaminosis; Deficiency Diseases; Malnutrition

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals; Blood Coagulation Factors; Biological Factors

Results Point of Contact

• Title: Sherman Vadim
• Organization: Houston Methodist Hosptial

vsherman@tmhs.org

713-441-5514

Study Officials

• Susan Miller, MD

  The Methodist Hospital Research Institute

  STUDY CHAIR

• Vadim Sherman, MD

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator/Principal Investigator

Study Record Dates

• First Submitted: June 28, 2011
• First Posted: June 29, 2011
• Study Start: July 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: September 1, 2015
• Last Updated: January 23, 2018
• Results First Posted: January 23, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)