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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Hospital Clinic of Barcelona.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT01637155
First received: July 10, 2012
Last updated: NA
Last verified: July 2012
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Obesity
Gastric Bypass
Gastrectomy
Drug: Cholecalciferol
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study to Evaluate the Pharmacokinetics of Vitamin D (Cholecalciferol) in Patients Undergoing Obesity Surgery in a Deficit Situation and After Standardization

Resource links provided by NLM:


Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • Comparison of pharmacokinetic parameters [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
    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. [ Time Frame: 36 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline levels of urinary excretion of calcium in both surgeries [ Time Frame: 36 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline levels of urinary excretion creatinine in both surgeries [ Time Frame: 36 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline in both biochemistry surgery [ Time Frame: 36 weeks ] [ Designated as safety issue: Yes ]
    Changes in total protein, albumin, phosphorus, magnesium and calcium will be analyzed.

  • Change from baseline alkaline phosphatase levels in both surgeries [ Time Frame: 36 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline body fat distribution by DEXA [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
  • Changes adherence in both surgeries [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
  • Incidence of adverse and clinical laboratory events for each of the surgeries [ Time Frame: 36 weeks ] [ Designated as safety issue: Yes ]
  • Proportion of patients with serious adverse events related to medication [ Time Frame: 36 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 44
Arms Assigned Interventions
Experimental: Cholecalciferol 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.
Other Names:
  • 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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01637155

Contacts
Contact: Violeta Moize, MD +34 93 227 54 00 vmoize@clinic.ub.es

Locations
Spain
Hospital Clinic i Provincial Barcelona Not yet recruiting
Barcelona, Spain, 08036
Contact: Violeta Moize, MD    +34 93 227 54 00    vmoize@clinic.ub.es   
Principal Investigator: Violeta Moize, MD         
Sponsors and Collaborators
Hospital Clinic of Barcelona
Investigators
Principal Investigator: Violeta Moize, MD Hospital Clinic i Provincial de Barcelona
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01637155     History of Changes
Other Study ID Numbers: PK-VIT-D
Study First Received: July 10, 2012
Last Updated: July 10, 2012
Health Authority: Spain: Spanish Drug and Medical Device Agency

Keywords provided by Hospital Clinic of Barcelona:
Cholecalciferol

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 16, 2014