Study to Evaluate the Pharmacokinetics of Vitamin D (Cholecalciferol) in Patients Undergoing Obesity Surgery in a Deficit Situation and After Standardization
PK-VIT-D
1 other identifier
interventional
44
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 10, 2012
CompletedFirst Posted
Study publicly available on registry
July 11, 2012
CompletedJuly 11, 2012
July 1, 2012
July 10, 2012
July 10, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Comparison of pharmacokinetic parameters
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.
36 weeks
Secondary Outcomes (10)
Comparison of the pharmacokinetic parameters between the two types of surgery
36 weeks
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
Change from baseline in both biochemistry surgery
36 weeks
- +5 more secondary outcomes
Study Arms (1)
Cholecalciferol
EXPERIMENTALInterventions
One baseline oral dose of 50.000 UI to determine pharmacokinetics. After 28 days, patients take a period of 90 days of standardization of cholecalciferol based on baseline levels. After this period, patients receive a second oral dose of 50.000 UI to determine a second pharmacokinetics.
Eligibility Criteria
You may qualify if:
- or more years old
- with bariatric surgery in the last 18 months (+/- 6 months)
- BMI: 25-33 kg/m2
- vitamin D3 (OK)\<20ng/mL.
- Signed consent form
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Clinic i Provincial Barcelona
Barcelona, Barcelona, 08036, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Violeta Moize, MD
Hospital Clinic i provincial de Barcelona
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 10, 2012
First Posted
July 11, 2012
Last Updated
July 11, 2012
Record last verified: 2012-07