Study to Evaluate the Pharmacokinetics of Vitamin D (Cholecalciferol) in Patients Undergoing Obesity Surgery in a Deficit Situation and After Standardization
- Registration Number
- NCT01637155
- Lead Sponsor
- Hospital Clinic of Barcelona
- Brief Summary
Set the pattern of vitamin D supplementation in obese patients undergoing bariatric surgery in deficit of vitamin D.
Patients receive a single oral dose of vitamin D, during the 28 days will be done a kinetic curve. Then and over the next 3 months, levels are normalized. Once normalized, will be administered another single oral dose to a second pharmacokinetic evaluation.
- Detailed Description
The study is conducted in obese patients undergoing bariatric surgery (for bypass or sleeve gastrectomy) in deficit of vitamin D.
Will include a total of 44 patients, 22 from each type of surgery. Patients receive a single oral dose of vitamin D of 50,000 IU. During the 28 days after administration of vitamin D will be done a kinetic curve determining plasma levels of vitamin D on 15 occasions. Then and over the next 3 months, levels are normalized by providing a daily oral dose for each patient. Once levels are normalized, will be administered another single oral dose of 50,000 IU vitamin D and proceed to a second pharmacokinetic evaluation determining plasma levels 15 times.
Patient follow up is approximately 36 weeks. Patients go to the screening visit, baseline visit and visits on days 1, 2, 3, 14 and 28 days after each pharmacokinetic evaluation.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 44
- 18 or more years old
- with bariatric surgery in the last 18 months (+/- 6 months)
- BMI: 25-33 kg/m2
- vitamin D3 (OK)<20ng/mL.
- Clinically stable, in the opinion of the investigator, at the time of inclusion
- Signed consent form
- pregnancy, lactation or intention during the study period.
- menopause
- GOP, GPT>2 UNL
- glomerular filtration rate <60ml/min
- previous renal lithiasis
- any digestive disease to suggest malabsorption, granulomatous diseases, diabetic gastroenteropathy and taking medication likely to interfere with the absorption of vitamin D and bone metabolism such as corticosteroids and anticonvulsants
- taking medication that interferes with calcium metabolism.
- cholecalciferol hypersensitivity.
- other bariatric surgery (different of by-pass or tubular gastrectomy)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cholecalciferol Cholecalciferol -
- Primary Outcome Measures
Name Time Method Comparison of pharmacokinetic parameters 36 weeks Comparison of the pharmacokinetic parameters of vitamin D according to a non compartimental approach (AUC0-t, AUC0-∞, Cmax and t1/2) between a state of vitamin D and after normalization of the same.
- Secondary Outcome Measures
Name Time Method Change from baseline body fat distribution by DEXA 36 weeks Changes adherence in both surgeries 36 weeks Change from baseline in both biochemistry surgery 36 weeks Changes in total protein, albumin, phosphorus, magnesium and calcium will be analyzed.
Change from baseline alkaline phosphatase levels in both surgeries 36 weeks Comparison of the pharmacokinetic parameters between the two types of surgery 36 weeks Comparison of the pharmacokinetic parameters of vitamin D according to a non-compartmental approach (AUC0-t, AUC0-∞, Cmax and t1 / 2) between the two types of surgery (bypass and sleeve gastrectomy)
Proportion of patients with secondary hyperparathyroidism in both surgeries. 36 weeks Change from baseline levels of urinary excretion of calcium in both surgeries 36 weeks Change from baseline levels of urinary excretion creatinine in both surgeries 36 weeks Incidence of adverse and clinical laboratory events for each of the surgeries 36 weeks Proportion of patients with serious adverse events related to medication 36 weeks
Trial Locations
- Locations (1)
Hospital Clinic i Provincial Barcelona
🇪🇸Barcelona, Spain