Efficacy of Vitamin D Supplementation in Bariatric Surgery Patients
|ClinicalTrials.gov Identifier: NCT01385098|
Recruitment Status : Completed
First Posted : June 29, 2011
Results First Posted : January 23, 2018
Last Update Posted : January 23, 2018
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|