Mode
Text Size
Log in / Sign up
N/A N=37 Treatment

Efficacy of Vitamin D Supplementation in Bariatric Surgery Patients

Obesity · Vitamin D Deficiency

Enrolled (actual)
37
Serious AEs
0.0%
Results posted
Jan 2018
Primary outcome: Primary: Vitamin D Concentrations, Pre Operative and Post Bariatric Surgery Following 12 Weeks of Vitamin D Supplementation — 19.1; 27.2 ng/mL — p=< 0.001

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Vitamin D3 and Calcium (Dietary_supplement)
Age
Adult, Older Adult · 18+ yrs
Sex
Female
Sponsor
Vadim Sherman, MD
Primary completion
May 2013

Outcome Measures

OutcomeResultp-value
PRIMARY
Vitamin D Concentrations, Pre Operative and Post Bariatric Surgery Following 12 Weeks of Vitamin D Supplementation
19.1; 27.2 < 0.001 sig
SECONDARY
Serum 25-hydroxyvitamin D Levels at Baseline and 12 Weeks of Daily Vit D Supplementation Post Roux-en Y OR Sleeve Gastrectomy
18.5; 19.6; 26.3; 28.1 0.013 sig

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.

Eligibility 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. - Exclusion Criteria:Subjects will be excluded if they have evidence of vitamin D deficiency ( 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. -
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01385098). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search