Obese patients after bariatric surgery MedDRA version: 14.1 Level: PT Classification code 10059610 Term: Obesity surgery System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: VITAMIN D3 Kern Pharma
Pharmaceutical Form: Oral solution
CAS Number: 8000055-64-3
Other descriptive name: VITAMIN D NOS
Concentration unit: IU international unit(s)
Concentration type: ra
Sponsors
Fundació Clínic per a la Recerca Biomèdica
Eligibility
Sex/Gender
Male
Inclusion criteria
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)=65 years) yes F.1.3.1 Number of subjects for this age range 44
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Establish vitamin D supplementation in obese patients after bariatric surgery.;Secondary Objective: -Evaluate the absorption of vitamin D -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
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Comparison of vitamin D pharmacokinetic parameters between by-pass or tubular gastrectomy - Proportion of patients with secondary hyperparathyroidism - Change from baseline in urinary creatinine and calcium excretion - Change from baseline in total protein, albumin, phosphor, magnesium and serum calcium - Change from baseline in alkaline phosphatase - Change form baseline in distribution of body fat by DEXA - Change in treatment compliance - Incidence of adverse events - Proportion of patients with serious adverse events related with study medication.;Timepoint(s) of evaluation of this end point: 16 weeks | — |
Countries
Spain
Contacts
Public ContactVioleta Moize
Hospital Clínic de Barcelona
Outcome results
None listed