Study to Evaluate the Pharmacokinetics of Vitamin D (Cholecalciferol) in Patients Undergoing Obesity Surgery in a Deficit Situation and After Standardization
NCT ID: NCT01637155
Last Updated: 2012-07-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
44 participants
INTERVENTIONAL
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cholecalciferol
Cholecalciferol
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.
Interventions
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Cholecalciferol
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Hospital Clinic of Barcelona
OTHER
Principal Investigators
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Violeta Moize, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Clinic i provincial de Barcelona
Locations
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Hospital Clinic i Provincial Barcelona
Barcelona, Barcelona, Spain
Countries
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Central Contacts
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Facility Contacts
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Violeta Moize, MD
Role: primary
Other Identifiers
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PK-VIT-D
Identifier Type: -
Identifier Source: org_study_id