Efficacy of Vitamin D Supplementation in Bariatric Surgery Patients
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Purpose
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 | Intervention |
|---|---|
|
Obesity Vitamin D Deficiency |
Dietary Supplement: Vitamin D3 and Calcium |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized 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.
| Estimated Enrollment: | 37 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | May 2012 |
| Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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:
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Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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.
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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.
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Contacts and Locations| United States, Texas | |
| The Methodist Hospital | Not yet recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Vadim Sherman, MD 713-441-5155 vsherman@tmhs.org | |
| Contact: Monica Flinn, RN (713) 441-9068 mflinn@tmhs.org | |
| Sub-Investigator: Carolyn E Moore, PhD | |
More Information
Publications:
| Responsible Party: | Dr. Vadim Sherman, The Methodist Hospital |
| ClinicalTrials.gov Identifier: | NCT01385098 History of Changes |
| Other Study ID Numbers: | 0311-0034 |
| Study First Received: | June 28, 2011 |
| Last Updated: | July 6, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by The Methodist Hospital System:
|
Vitamin D Bariatric surgery Roux-en Y surgery Gastric sleeve surgery Parathyroid Hormone |
Additional relevant MeSH terms:
|
Vitamin D Deficiency Obesity Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms Avitaminosis Deficiency Diseases Malnutrition |
Calcium, Dietary Cholecalciferol Vitamin D Ergocalciferols Vitamins Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on May 16, 2013