Clinical trial NCT01637155: Study to Evaluate the Pharmacokinetics of Vitamin D (Cholecalciferol) in Patients Undergoing Obesity Surgery in a Deficit Situation and After Standardization
Official title: Study to Evaluate the Pharmacokinetics of Vitamin D (Cholecalciferol) in Patients Undergoing Obesity Surgery in a Deficit Situation and After Standardization
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Obesity
Gastric Bypass
Gastrectomy
Keywords: Cholecalciferol
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2012-07-11
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: The study is conducted in obese patients undergoing bariatric surgery (for bypass or sleeve gastrectomy) in deficit of vitamin D.

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.

Eligibility 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)

Primary outcomes:
measure: Comparison of pharmacokinetic parameters
timeFrame: 36 weeks
Secondary outcomes:
measure: Comparison of the pharmacokinetic parameters between the two types of surgery
timeFrame: 36 weeks
measure: Proportion of patients with secondary hyperparathyroidism in both surgeries.
timeFrame: 36 weeks
measure: Change from baseline levels of urinary excretion of calcium in both surgeries
timeFrame: 36 weeks
measure: Change from baseline levels of urinary excretion creatinine in both surgeries
timeFrame: 36 weeks
measure: Change from baseline in both biochemistry surgery
timeFrame: 36 weeks
measure: Change from baseline alkaline phosphatase levels in both surgeries
timeFrame: 36 weeks
measure: Change from baseline body fat distribution by DEXA
timeFrame: 36 weeks
measure: Changes adherence in both surgeries
timeFrame: 36 weeks
measure: Incidence of adverse and clinical laboratory events for each of the surgeries
timeFrame: 36 weeks
measure: Proportion of patients with serious adverse events related to medication
timeFrame: 36 weeks
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial Barcelona
Study officials:
affiliation: Hospital Clinic i provincial de Barcelona
name: Violeta Moize, MD
role: PRINCIPAL_INVESTIGATOR
References: