Study to Evaluate the Pharmacokinetics of Vitamin D (Cholecalciferol) in Patients Undergoing Obesity Surgery in a Deficit Situation and After Standardization

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Clinic of Barcelona
• Treatments: Cholecalciferol; Ergocalciferols; Vitamin D; Vitamins

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)