Efficacy of Vitamin D Supplementation in Bariatric Surgery Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Texas Woman's University
Information provided by (Responsible Party):
Carolyn Moore, The Methodist Hospital System
ClinicalTrials.gov Identifier:
NCT01385098
First received: June 28, 2011
Last updated: August 2, 2013
Last verified: August 2013
  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

Resource links provided by NLM:


Further study details as provided by The Methodist Hospital System:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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: December 2013
Primary Completion Date: May 2013 (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:
  • Celebrate ® calcium citrate plus vitamin D3
  • Celbrate ® multi-vitamin

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders 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.

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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01385098

Locations
United States, Texas
The Methodist Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
The Methodist Hospital System
Texas Woman's University
  More Information

Publications:
Responsible Party: Carolyn Moore, Associate Professor, The Methodist Hospital System
ClinicalTrials.gov Identifier: NCT01385098     History of Changes
Other Study ID Numbers: 0311-0034
Study First Received: June 28, 2011
Last Updated: August 2, 2013
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
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Calcium, Dietary
Cholecalciferol
Ergocalciferols
Vitamin D
Vitamins
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 21, 2014