Efficacy of Vitamin D Supplementation in Bariatric Surgery Patients
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Preoperative Vitamin D Status and Efficacy of Therapeutic Vitamin D Supplementation Postoperatively in Bariatric Surgery Patients|
- Improvement or maintenance of vitamin D status following bariatric surgery after 12 weeks of vitamin D3 supplementation. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Efficacy of supplementation with 2,000 IU of vitamin D3 for 12 weeks will significantly increase or maintain mean serum 25(OH)D levels in obese subjects following bariatric surgery compared to baseline levels.
- 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. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]The percent response above baseline to daily supplementation with 2,000 IU of vitamin D3 will be compared between Roux-en Y and sleeve gastrectomy patients. We anticipate that vitamin D supplementation of Roux-en Y bariatric surgery patients will be less effective in improving or maintaining vitamin D status.
|Study Start Date:||July 2011|
|Study Completion Date:||September 2015|
|Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
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
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01385098
|United States, Texas|
|The Methodist Hospital|
|Houston, Texas, United States, 77030|
|Study Chair:||Susan Miller, MD||The Methodist Hospital Research Institute|
|Principal Investigator:||Vadim Sherman, MD||The Methodist Hospital Research Institute|