Study to evaluate the pharmacokinetic of vitamin D in patients with obesity after bariatric surgery

Active, not recruiting

Conditions: Obese patients after bariatric surgery
MedDRA version: 14.1Level: PTClassification code 10059610Term: Obesity surgerySystem Organ Class: 10042613 - Surgical and medical procedures
Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]

Registration Number: EUCTR2011-006163-22-ES

Lead Sponsor: Fundació Clínic per a la Recerca Biomèdica

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Male

Target Recruitment: Not specified

Inclusion Criteria

- 18 or more years old
- with bariatric surgery in the last 18 months (+/- 6 months)
- BMI: 25-33 kg/m2
- vitamina D3 (OK)<20ng/mL.
- Clinically stable, in the opinion of the investigator, at the time of inclusion
- Signed consent form
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 44
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 44

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 meabolism.
- cholecalciferol hypersensitivity.
- other bariatric surgery (different of by-pass or tubular gastrectomy)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Establish vitamin D supplementation in obese patients after bariatric surgery.;Secondary Objective: -Evaluate the absorption of vitamin D <br>-Compare the pharmacokinetics of vitamin D between bypass and tubular gastrectomy Bariatric Surgery;Primary end point(s): Pharmacokiteics parameters of vitamin D (AUC0-t, AUC0-?, Cmax y t1/2);Timepoint(s) of evaluation of this end point: 16 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Comparison of vitamin D pharmacokinetic parameters between by-pass or tubular gastrectomy<br>- Proportion of patients with secondary hyperparathyroidism<br>- Change from baseline in urinary creatinine and calcium excretion <br>- Change from baseline in total protein, albumin, phosphor, magnesium and serum calcium<br>- Change from baseline in alkaline phosphatase<br>- Change form baseline in distribution of body fat by DEXA<br>- Change in treatment compliance<br>- Incidence of adverse events<br>- Proportion of patients with serious adverse events related with study medication.;Timepoint(s) of evaluation of this end point: 16 weeks