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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cholecalciferol | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cholecalciferol | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 36 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 36 weeks |
| Proportion of patients with secondary hyperparathyroidism in both surgeries. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Violeta Moize, MD | Contact | +34 93 227 54 00 | vmoize@clinic.ub.es |
| Name | Affiliation | Role |
|---|---|---|
| Violeta Moize, MD | Hospital Clinic of Barcelona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinic i Provincial Barcelona | Barcelona | Barcelona | 08036 | Spain |
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|
|
| 36 weeks |
| Change from baseline levels of urinary excretion of calcium in both surgeries | 36 weeks |
| Change from baseline levels of urinary excretion creatinine in both surgeries | 36 weeks |
| Change from baseline in both biochemistry surgery | Changes in total protein, albumin, phosphorus, magnesium and calcium will be analyzed. | 36 weeks |
| Change from baseline alkaline phosphatase levels in both surgeries | 36 weeks |
| Change from baseline body fat distribution by DEXA | 36 weeks |
| Changes adherence in both surgeries | 36 weeks |
| Incidence of adverse and clinical laboratory events for each of the surgeries | 36 weeks |
| Proportion of patients with serious adverse events related to medication | 36 weeks |
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| D000069956 | Chocolate |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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