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Study to Evaluate the Pharmacokinetics of Vitamin D (Cholecalciferol) in Patients Undergoing Obesity Surgery in a Deficit Situation and After Standardization (PK-VIT-D)

Primary Purpose

Obesity, Gastric Bypass, Gastrectomy

Status
Unknown status
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Cholecalciferol
Sponsored by
Hospital Clinic of Barcelona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Cholecalciferol

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Hospital Clinic i Provincial Barcelona

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cholecalciferol

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Comparison of the pharmacokinetic parameters between the two types of surgery
Comparison of the pharmacokinetic parameters of vitamin D according to a non-compartmental approach (AUC0-t, AUC0-∞, Cmax and t1 / 2) between the two types of surgery (bypass and sleeve gastrectomy)
Proportion of patients with secondary hyperparathyroidism in both surgeries.
Change from baseline levels of urinary excretion of calcium in both surgeries
Change from baseline levels of urinary excretion creatinine in both surgeries
Change from baseline in both biochemistry surgery
Changes in total protein, albumin, phosphorus, magnesium and calcium will be analyzed.
Change from baseline alkaline phosphatase levels in both surgeries
Change from baseline body fat distribution by DEXA
Changes adherence in both surgeries
Incidence of adverse and clinical laboratory events for each of the surgeries
Proportion of patients with serious adverse events related to medication

Full Information

First Posted
July 10, 2012
Last Updated
July 10, 2012
Sponsor
Hospital Clinic of Barcelona
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1. Study Identification

Unique Protocol Identification Number
NCT01637155
Brief Title
Study to Evaluate the Pharmacokinetics of Vitamin D (Cholecalciferol) in Patients Undergoing Obesity Surgery in a Deficit Situation and After Standardization
Acronym
PK-VIT-D
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

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Hospital Clinic of Barcelona

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Gastric Bypass, Gastrectomy
Keywords
Cholecalciferol

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cholecalciferol
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Cholecalciferol
Other Intervention Name(s)
Oral Cholecalciferol for pharmacokinetics determination:, - VITAMIN D3 Kern Pharma mixed with chocolate or vanilla custard, Standarization cholecalciferol dose depends on baseline levels as indicated below:, - <10 2800 UI, - 10-15 2000 UI, - 15-20 1200 UI, - 20-30 1000 UI
Intervention Description
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.
Primary Outcome Measure Information:
Title
Comparison of pharmacokinetic parameters
Description
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.
Time Frame
36 weeks
Secondary Outcome Measure Information:
Title
Comparison of the pharmacokinetic parameters between the two types of surgery
Description
Comparison of the pharmacokinetic parameters of vitamin D according to a non-compartmental approach (AUC0-t, AUC0-∞, Cmax and t1 / 2) between the two types of surgery (bypass and sleeve gastrectomy)
Time Frame
36 weeks
Title
Proportion of patients with secondary hyperparathyroidism in both surgeries.
Time Frame
36 weeks
Title
Change from baseline levels of urinary excretion of calcium in both surgeries
Time Frame
36 weeks
Title
Change from baseline levels of urinary excretion creatinine in both surgeries
Time Frame
36 weeks
Title
Change from baseline in both biochemistry surgery
Description
Changes in total protein, albumin, phosphorus, magnesium and calcium will be analyzed.
Time Frame
36 weeks
Title
Change from baseline alkaline phosphatase levels in both surgeries
Time Frame
36 weeks
Title
Change from baseline body fat distribution by DEXA
Time Frame
36 weeks
Title
Changes adherence in both surgeries
Time Frame
36 weeks
Title
Incidence of adverse and clinical laboratory events for each of the surgeries
Time Frame
36 weeks
Title
Proportion of patients with serious adverse events related to medication
Time Frame
36 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Violeta Moize, MD
Phone
+34 93 227 54 00
Email
vmoize@clinic.ub.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Violeta Moize, MD
Organizational Affiliation
Hospital Clinic i provincial de Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clinic i Provincial Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Violeta Moize, MD
Phone
+34 93 227 54 00
Email
vmoize@clinic.ub.es
First Name & Middle Initial & Last Name & Degree
Violeta Moize, MD

12. IPD Sharing Statement

Learn more about this trial

Study to Evaluate the Pharmacokinetics of Vitamin D (Cholecalciferol) in Patients Undergoing Obesity Surgery in a Deficit Situation and After Standardization

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