ObesityPhase 2PK-VIT-DNCT01637155
Study to Evaluate the Pharmacokinetics of Vitamin D (Cholecalciferol) in Patients Undergoing Obesity Surgery in a Deficit Situation and After Standardization
A Phase 2 study testing Cholecalciferol in people with Obesity and Gastric Bypass, run by Hospital Clinic of Barcelona at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Gastric Bypass, Gastrectomy
- What is being tested?
- Cholecalciferol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSpain
- Study dates
- Start not givento not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- taking medication that interferes with calcium metabolism.
- cholecalciferol hypersensitivity.
- other bariatric surgery (different of by-pass or tubular gastrectomy)
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Clinic i Provincial Barcelona
Barcelona, Barcelona, 08036
Violeta Moize, MD, +34 93 227 54 00, vmoize@clinic.ub.es
Violeta Moize, MD
About this study
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.
Read the 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.
- Conditions
- Obesity, Gastric Bypass, Gastrectomy
- Being tested
- Cholecalciferol
- Keywords
- Cholecalciferol
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholecalciferolDrug
Also called 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
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.
| Study group | Role | What they receive |
|---|---|---|
| Cholecalciferol | Experimental | Not described Receives: Drug: Cholecalciferol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 36 weeks
Secondary outcomes (10)
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)
Measured: 36 weeks
Proportion of patients with secondary hyperparathyroidism in both surgeries.
Measured: 36 weeks
Change from baseline levels of urinary excretion of calcium in both surgeries
Measured: 36 weeks
Change from baseline levels of urinary excretion creatinine in both surgeries
Measured: 36 weeks
Change from baseline in both biochemistry surgery
Changes in total protein, albumin, phosphorus, magnesium and calcium will be analyzed.
Measured: 36 weeks
Change from baseline alkaline phosphatase levels in both surgeries
Measured: 36 weeks
Change from baseline body fat distribution by DEXA
Measured: 36 weeks
Changes adherence in both surgeries
Measured: 36 weeks
Incidence of adverse and clinical laboratory events for each of the surgeries
Measured: 36 weeks
Proportion of patients with serious adverse events related to medication
Measured: 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Investigators
- Violeta Moize, MD, Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01637155
- Sponsor's protocol ID
- PK-VIT-D
- Acronym
- PK-VIT-D
- Status last verified
- Jul 2012
- First submitted
- 10 Jul 2012
- Last updated
- 11 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Evaluate the Pharmacokinetics of Vitamin D (Cholecalciferol) in Patients Undergoing Obesity Surgery in a Deficit Situation and After Standardization
- ClinicalTrials.gov ID
- NCT01637155
- Acronym / sponsor ID
- PK-VIT-D / PK-VIT-D
- Conditions
- Obesity, Gastric Bypass, Gastrectomy
- Keywords
- Cholecalciferol
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- First posted
- 11 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cholecalciferol | Experimental | Drug: Cholecalciferol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- pregnancy, lactation or intention during the study period.
- menopause
- GOP, GPT>2 UNL
- glomerular filtration rate <60ml/min
- previous renal lithiasis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CholecalciferolAlso: 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 UIOne 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. | Drug | Cholecalciferol |
Primary outcome
Comparison of pharmacokinetic parameters
Time frame: 36 weeks
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.
10 secondary outcomes
Comparison of the pharmacokinetic parameters between the two types of surgery
Time frame: 36 weeks
Proportion of patients with secondary hyperparathyroidism in both surgeries.
Time frame: 36 weeks
Change from baseline levels of urinary excretion of calcium in both surgeries
Time frame: 36 weeks
Change from baseline levels of urinary excretion creatinine in both surgeries
Time frame: 36 weeks
Change from baseline in both biochemistry surgery
Time frame: 36 weeks
Change from baseline alkaline phosphatase levels in both surgeries
Time frame: 36 weeks
Change from baseline body fat distribution by DEXA
Time frame: 36 weeks
Changes adherence in both surgeries
Time frame: 36 weeks
Incidence of adverse and clinical laboratory events for each of the surgeries
Time frame: 36 weeks
Proportion of patients with serious adverse events related to medication
Time frame: 36 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Violeta Moize, MD principal investigator
Hospital Clinic of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cholecalciferol in people with Obesity and Gastric Bypass, run by Hospital Clinic of Barcelona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Violeta Moize, MD (+34 93 227 54 00, vmoize@clinic.ub.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of pharmacokinetic parameters (time frame: 36 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2012.