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

Obesity Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01637155
• Other study ID #: PK-VIT-D
• Status: Not yet recruiting
• Phase: Phase 2
• First received: July 10, 2012
• Last updated: July 10, 2012

Study information

• Verified date: July 2012
• Source: Hospital Clinic of Barcelona
• Contact: Violeta Moize, MD
• Phone: +34 93 227 54 00
• Email: vmoize[@]clinic.ub.es
• Is FDA regulated: No
• Health authority: Spain: Spanish Drug and Medical Device Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 44
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastrectomy
• Gastric Bypass
• Obesity

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Spain	Hospital Clinic i Provincial Barcelona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of pharmacokinetic parameters	Comparison of the pharmacokinetic parameters of vitamin D according to a non compartimental approach (AUC0-t, AUC0-8, Cmax and t1/2) between a state of vitamin D and after normalization of the same.	36 weeks	No
Secondary	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, AUC0-8, Cmax and t1 / 2) between the two types of surgery (bypass and sleeve gastrectomy)	36 weeks	No
Secondary	Proportion of patients with secondary hyperparathyroidism in both surgeries.		36 weeks	Yes
Secondary	Change from baseline levels of urinary excretion of calcium in both surgeries		36 weeks	Yes
Secondary	Change from baseline levels of urinary excretion creatinine in both surgeries		36 weeks	Yes
Secondary	Change from baseline in both biochemistry surgery	Changes in total protein, albumin, phosphorus, magnesium and calcium will be analyzed.	36 weeks	Yes
Secondary	Change from baseline alkaline phosphatase levels in both surgeries		36 weeks	Yes
Secondary	Change from baseline body fat distribution by DEXA		36 weeks	No
Secondary	Changes adherence in both surgeries		36 weeks	No
Secondary	Incidence of adverse and clinical laboratory events for each of the surgeries		36 weeks	Yes
Secondary	Proportion of patients with serious adverse events related to medication		36 weeks	Yes